Application of Information-Motivation-Behavioral model–based Continuity of Care on the Peri-implantitis recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial

doi:10.21203/rs.3.rs-3419299/v1

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Research Article

Application of Information-Motivation-Behavioral model–based Continuity of Care on the Peri-implantitis recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial

https://doi.org/10.21203/rs.3.rs-3419299/v1

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Aims

To observe the effect of information-motivation-behavioral skill (IMB) model–based continuity of care for diabetic implant overdenture (IOD) patients with peri-implantitis.

Design

: A randomised controlled trial.

Methods

We recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. The control group received routine postoperative medical advice, whereas the experimental group was given an IMB model–based continuity of care.

Results

Thirty-one patients having a total of 106 implants with peri-implantitis completed the study. The Spearman correlation coefficients indicated that the plaque index (rs = 0.2475, p < 0.01), follow-up compliance (rs=-0.2326, p < 0.01), oral cleanliness compliance (rs=-0.1867, p < 0.05) and blood glucose control compliance (rs=-0.1749, p < 0.05) correlated weakly with peri-implant bone resorption at 12 months. Patient satisfaction in the experimental group was greater than that in the control group (p < 0.05). Additionally, the peri-implant bone resorption was lesser in the experimental group than in the control group, both at 6 and 12 months after treatment (p < 0.05).

Conclusion

With the IMB model–based continuity of care constructed, a remote management system for diabetic IOD patients could be used to enhance the patients’ understanding of peri-implantitis and diabetes, improve their medical and daily life behaviors, thereby promoting recovery.

information-motivation-behavioral skill model

continuity of care

peri-implantitis

diabetes

implant overdenture

bone resorption

compliance

With the advances in implantation technology, edentulous patients are increasingly opting for implant restoration rather than traditional complete dentures. Implant overdenture (IOD) connects the upper structure of restorations to implants through attachment, thus providing retention and stability. Compared with the implant-supported fixed prosthesis (ISFP), IOD is more cost-effective and has lower requirements for bone condition. The use of IOD also minimizes aesthetic problems such as soft tissue loss caused by bone resorption on a plastic base. In addition, patients can remove the IOD by themselves, which makes it easier to avoid food residue and is conducive to oral hygiene maintenance. However, if there is a lack of cleanliness, IOD is prone to bacterial accumulation and peri-implant tissue damage.

There is substantial evidence to show that there is a close interaction between glucose level and bone metabolism [1]. Hyperglycemia changes the composition of the peri-implant subgingival microflora [2]. Additionally, blood glucose level is significantly correlated with the incidence of peri-implantitis. A systematic review and meta-analysis has shown that diabetic patients with well-controlled blood glucose levels have a significantly lower risk of peri-implantitis and less marginal bone resorption than in those with poorly controlled blood glucose levels [3].

Continuity of care involves a series of actions designed to ensure that patients undergoing a transfer from different health care settings (e.g., from hospital to home) or within the same setting (e.g., different units in the hospital) receive different levels of collaborative and continuous care [4], including discharge planning, referrals, and continuous follow-up and guidance after the patient returns home [5]. It encompasses the roles of both provider and receiver. Patients who actively participate will receive more substantial treatment [4]. Additionally, a retrospective cohort study has shown that continuity of care is associated with lower risk of cardiovascular disease risk among individuals with type 2 diabetes [6]. Another prospective cohort has shown that the application of continuity of care in the dental field enhances oral anticancer therapy adherence [7].

The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements—information, motivation, and behavioral skills—and is aimed at transferring patients’ behavior into a positive direction [8], including self-behavior management ability, medication compliance and so on [9]. For diabetic patients with poor adherence, the IMB model of care can be considered [10].

This model may be particularly useful in diabetic IOD patients since they are more prone to peri-implantitis than patients with other types of implant restorations or non-diabetic patients. However, the efficacy of the combination of the IMB model and continuity of care in improving healing, bone resorption, disease management and control, and quality of life in the specific population group of diabetic IOD patients remains unclear. To this end, the current study was aimed at investigating whether this model of care can help achieve better clinical outcomes and improve patient satisfaction with the services provided, thereby obtaining data to serve as a reference and scientific basis for the improvement of intervention plans.

2.1 Design

This study was a randomised controlled open trial and followed the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) statement (Schulz et al., 2010). We enrolled 32 diabetic IOD patients, with a total of 112 problematic implants, who developed peri-implantitis and were managed at the department of Implantology at Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine. The patients were randomly assigned to one of two equal groups: a control group or an experimental group, by using a table of random numbers. After the completion of peri-implantitis treatment, patients in the experimental group were provided with a one-year IMB model-based continuity of care, while patients in the control group were provided with standard care. The demographic and clinical characteristics of the two patient groups, including age and gender, were shown in Table 1. The study protocol was approved by the ethics committee of School of Stomatology, Zhejiang University School of Medicine (approval number: 2022 − 198 (R)).

Table 1

Patient Characteristics of the Control and Experimental Groups
	Group		Number	Percentage %	p
Gender	Experiment	Male Female	10 6	62.50 37.50	0.658
Gender	Control	Male Female	10 5	66.67 33.33	0.658
Smoking	Experiment	Smoking Non-smoking	9 7	56.25 43.75	0.404
Smoking	Control	Smoking Non-smoking	7 8	46.67 53.33	0.404
Note: p < 0.05 is considered statistically significant

2.1.1 Inclusion criteria

The inclusion criteria in this study were as follows: (1) IOD patients who had type 2 diabetes with peri-implantitis in at least one implant, (2) patients with clear consciousness and good communicative competence, (3) patients who could take good care of themselves and were proficient in using mobile communication and internet devices, and (4) patients who agreed to participate in our study.

2.1.2 Exclusion criteria

Patients with any of the following were excluded from our study: (1) type 1 diabetes and other particular types of diabetes, (2) severe cognitive dysfunction or psychiatric disorders, and (3) inability to use mobile electronic devices.

2.2 Sampling

In this study, the sample size required was calculated by G*Power analysis software ( effect size = 0.90, power = 0.80 and α = 0.05 were set for the sample number estimation, and a one-tailed test was adopted ). The minimum sample number was calculated to be at least 32.

2.3 Study intervention

2.3.1 Peri-implantitis treatment

For implants that could be retained, we used the curette or ultrasound instruments to mechanically scrape off the granulation tissue around the implants, along with the local application of minocycline ointment (perioline) in the pocket of the implants once a week for four consecutive weeks.

2.3.2 Experimental group

Patients in the experimental group received further intervention in addition to standard care. First of all, an internet care model for patients was set up for the convenience of implementing continuity of care based on evidence-based nursing principles. The identity of the participants was confirmed and they consented to enter the platform, where they could communicate with nurses via messages. The nurses were required to answer the patients’ online queries and provided continuity of care based on the IMB model.

Intervention through the IMB model–based continuity of care was focused on three aspects:

(1) Information intervention: (a) instructing patients to follow the official account of the dental implant department and introducing the instructions to use the application, (b) regularly updating the educational content and disseminating detailed knowledge about the prevention and treatment of oral diseases, especially for peri-implantitis, (c) conducting regular lectures on health education to introduce the dangers and complications of diabetes and emphasize the significance of controlling blood glucose levels.

(2) Motivation intervention: (a) providing an online platform for patients to interact with nurses and doctors, where they can obtain professional answers. (b) assessing the risk factors related to peri-implantitis and diabetes and developing appropriate interventions and (c) monitoring the patients’ blood glucose status and medication compliance. If they showed negative emotions or undesirable clinical manifestations, we supported and encouraged them to sustain treatment and arranged for further consultation.

(3) Behavioral skills intervention: (a) providing feedback on the correct use of tools and implants and cleaning of the overdentures by observing the cleaning videos that the patients were required to upload, (b) sending automated notifications to remind patients about further consultation 3 days in advance, and (c) providing suggestions for proper diet and exercise.

2.3.3 Control group intervention methods

For the control group, standard care was provided in the form of routine health education regarding various topics, such as proper brushing techniques, use of an oral irrigator, and other auxiliary tools. The patients were followed-up via telephonic interviews to monitor their condition, including usage of the implant and lifestyle changes; the interviews were conducted at 2 weeks, 1 month, 3 months, and 6 months after treatment. Data were collected about oral health, blood glucose control, lifestyle habits, and comorbidities by using the compliance questionnaire. Appropriated health education was provided if there were any concerns such as gingival swelling, plaque accumulation, and elevated blood glucose levels.

2.4 Date collection

2.4.1 Compliance

The Morisky Medication Adherence Scale was used to evaluate patient compliance with oral cleanliness, follow-up and blood glucose control. The total score of this questionnaire is 8 points, and a score of < 6 points indicates poor compliance, whereas a score of 8 points indicates excellent compliance. 6–8 points indicate good compliance.

2.4.2 Patient satisfaction

An in-house questionnaire was developed to assess the patients’ satisfaction regarding nurses service attitude, timeliness of responses, effectiveness in controlling peri-implant inflammation, and feelings about their own condition. The scores ranged from 1 to 10, with higher scores indicating greater satisfaction. Patient satisfaction was assessed on follow-up at 12 months after treatment.

2.4.3 Plaque index (PI)

The Turkey-Modified Quigley-Hein Plaque Index [11] was performed by nurses with a plaque indicator on the day they came for further consultation 6 months after treatment. The scores ranged from 0 to 5, higher scores indicated worse oral hygiene.

2.4.4 Bone loss

Each patient received at least 3 panoramic radiographs on the first day patients came to our hospital for treatment of peri-implantitis (T0), 6 months after treatment (T1), and 12 months after treatment (T2), respectively. The distances from the most coronal implant-bone junction site to the implant platform in both the mesial and distal sites of the implants were measured and recorded as measured mesial bone level (mMBL) and measured distal bone level (mDBL) respectively. The lengths of the implants were measured in order to calibrate the measurements by using the actual known length of the implant [12], for example, the actual MBL(aMBL) = mMBL × (actual implant length) / (measured implant length). We obtained the average value of aMBL and aDBL, regarded T0 as the baseline, and subtracted T0 from T1 or T2 to acquire the bone loss in 6 or 12 months after treatment. Reference lines and points used in the measurements were shown in Fig. 2.

2.5 Date analysis

SPSS 25.0 statistical software was used to analysis the data. The quantitative data was represented as mean ± standard deviation, and the two independent groups having normal distribution was compared with independent samples t-test. The qualitative data was described using frequency and percentages and tested using Fisher's exact probability method. Spearman test was used to explore the correlation between peri-implant bone resorption at 12 months and the plaque index, follow-up compliance, oral hygiene compliance, and blood glucose control compliance. Because one patient usually had multiple problematical implants, we matched the individual’s PI and compliance scores to each implant. The p < 0.05 indicated statistically significant differences.

SPSS 25.0 statistical software was used to analyze the data. The quantitative data was represented as mean ± standard deviation, and and the two independent groups having normal distribution was compared using independent samples t-test. Qualitative data were described using frequency and percentages and tested using Fisher’s exact probability method. Spearman test was used to explore the correlation between peri-implant bone resorption at 12 months and the plaque index, follow-up compliance, oral hygiene compliance, and blood glucose control compliance. A p value of < 0.05 indicated a statistically significant difference.

2.6 Ethical considerations

The current study was approved by the ethics committee of School of Stomatology, Zhejiang University School of Medicine (approval number: 2022 − 198 (R)). Patients meeting the inclusion criteria were explained the clinical trial study protocol, and then, we obtained their informed consent.

3.1 Patient characteristics

A total of 32 patients with 110 problematic implants were included in our prospective study. One patient with four problematic implants in the control group was lost to follow-up at 12 months. Thus, a total of 31 patients completed the entire study, including 16 patients with 52 problematic implants in the experimental group and 15 patients with 54 problematic implants in the control group(Figure 1). The mean±SD age in the experimental group and control group was comparable (63.75±12.38 y vs 65.53±12.15 y, p=0.971). Additionally, the distribution of gender or smoking history showed no relevant differences between the two groups.

3.2 Patient compliance

Compliance with oral hygiene, follow-up, and blood glucose control was substantially better in the experimental group than in the control group (p<0.05) (Table 2). The findings indicated that with our IMB model–based continuity of care improved patients’ attention to their own health and helped them develop good medical habits.

Table 2 Comparison of compliance, PI and satisfaction in the experimental and control groups after the intervention

	Experimental group (n=16)	Control group (n=15)	t	p
Oral Cleanliness Compliance	6.81±0.56	4.47±2.84	-5.064	0.000
Follow-up Compliance	7.50±0.53	5.20±1.60	-6.251	0.000
Blood Glucose Control Compliance	7.13±0.92	6.00±2.29	-2.491	0.019
PI	1.63±0.78	3.87±0.98	6.654	0.000
Satisfaction	9.75±0.20	6.67±2.10	-8.124	0.000

Note: p<0.05 is considered statistically significant

Abbreviations: PI, plaque index

3.3 Plaque index (PI)

The plaque index (PI) on the surface of the abutment was assessed 6 months after treatment, we detected the plaque index when they came for further consultation. As shown in Table 2, the PI of the experimental group was considerably lower than that of the control group (p<0.01).

3.4 Satisfaction survey

A total of 31 patient satisfaction survey questionnaires were distributed, and all of them were collected after completion. Cronbach's α for this questionnaire was 0.72, and the retest reliability was 0.70, indicating good reliability and validity. As shown in Table 2, the satisfaction ratings in the experimental group were significantly higher than that in the control group (p<0.05).

3.5 Peri-implant bone resorption

Although continuous bone resorption occurred after treatment, just as we expected, peri-implant bone resorption in the experimental group was notably less than that in the control group, both at 6-month and or 12 months (p<0.05) (Table 3, Figure 3). The discrepancy in clinical parameters indicated that our continuity of care could truly improve the recovery of peri-implantitis.

Table3 Comparison of alveolar bone crest resorption between the experimental and control groups after the intervention

	Experimental group (n=52)	Control group (n=54)	t	p
6 months after treatment	0.39±0.20	0.74±0.48	-3.074	0.002
12 months after treatment	0.67±0.41	1.19±0.85	-3.317	0.001

Note: p<0.05 is considered statistically significant

3.6 Correlation analysis

Correlation analysis with the Spearman correlation coefficients demonstrated that the PI (r_s=0.2475, p<0.01) was positively correlated with the severity of peri-implant bone resorption. Compliance to follow-up (r_s=-0.2326, p<0.01), oral cleanliness (r_s=-0.1867, p<0.05), and blood glucose control (r_s=-0.1749, p<0.05) were negatively correlated with the severity of peri-implant bone resorption at 12 months (Table 4).

Table 4 Spearman correlation coefficients for peri-implant bone resorption at 12 months, plaque index, and patient compliance

Association with bone resorption	r_s	95% CI	p
Plaque Index	0.2475	0.0596 to 0.4185	0.007
Follow-up Compliance	-0.2326	-0.4053 to -0.0438	0.008
Oral Cleanliness Compliance	-0.1867	-0.3645 to 0.0042	0.028
Blood Glucose Control Compliance	-0.1749	-0.3539 to 0.0164	0.037

Note: p<0.05 is considered statistically significant

Diabetic patients, especially those with poorly controlled blood glucose levels, are prone to develop peri-implantitis and bone resorption. A recent meta-analysis has shown that patients with hyperglycemia (fasting plasma glucose level of at least 100 mg/dL) have a 50% greater risk of peri-implantitis by 50% than patients with normoglycemia [13]. Studies have also shown that an increase in glycated hemoglobin levels is paralleled by an increase in both the tendency of implants to bleed on probing and the degree of bone loss [14]. However, some studies have shown that due to the long duration and unreliable efficacy of the treatment process, diabetic IOD patients are relatively poor at self-management and sometimes neglect to maintain oral hygiene and denture cleaning. Hyperglycemia alters the biological behavior of inflammatory cells and reduces the immune response. The rate of peri-implant bone resorption has been shown to be negatively correlated with oral cleanliness and blood glucose control, which suggests that good oral hygiene and blood glucose control can reduce the incidence of bone resorption. Therefore, along with peri-implant cleaning and anti-inflammatory treatment, control and maintenance of blood glucose levels within normal limits should be the primary goal of treatment. If adequate blood glucose control is not achieved, a prolonged state of inflammation may lead to progressive resorption of the peri-implant bone and ultimately to the removal of the implant.

Continuity of care is an extension of inpatient care that allows discharged patients to receive continuous health care during the recovery period, thereby promoting wound healing and reducing the risk of deterioration. There are three aspects [15] to continuity of care, including continuity of information, continuity of management, and continuity of relationships. Continuity of information involves the tailoring of the standard care to each individual in accordance with the patient’s preferences, habits, disease status, etc. Stability of the patient’s condition is promoted by the continuity of management. Management must be in line with the involved subjects’ information. By monitoring peri-implant tissue status, PI, and blood glucose levels frequently, we gained a better understanding of their health status, which enabled us to make informed decisions and provide appropriate treatment. Continuity of the relationship highlights the ongoing relationship between the patient and the healthcare provider. We could provide scientific and targeted care when continuity of care was combined with the IMB model. To implement continuity of care based on the IMB model, we established a close relationship with our patients through a web-based platform. This allowed for a close monitoring of their condition and health behavior. If they encountered medical concerns, they could contact us through the platform and we would communicate with them in a timely manner or arrange for them to come in to see us. The platform served as a tool for information sharing and care coordination between healthcare providers and patients. With the IMB model–based continuity of care, patients could be provided proper education regarding diabetes and peri-implantitis to improve their awareness of disease. This helped patients develop a positive attitude towards accepting treatment and mobilized their motivation for therapy.

Our study findings indicated that continuity of care helped promote compliance and enhance patient satisfaction. This implied that providing continuity of care through the online platform helped build the patients’ trust in the service providers and ensure a more comfortable medical experience. This made patients more confident regarding their treatment. The patients in the experimental group showed better compliance with the treatment, lower PI, and less bone resorption than those in the control group. The inflammatory changes in the peri-implant tissue were indeed improved by the IMB model-based continuity of care. However, due to their lower immune function, the diabetic patients did not show post-treatment improvement to the same extent as that in non-diabetic patients. We also noted that even with proper treatment of both peri-implantitis and diabetes, some patients still had a substantial amount of bone resorption at follow-up, although the rate of bone resorption may have been reduced. This finding was similar to that of a recent meta-analysis, which showed that despite well-controlled blood glucose levels, diabetic patients had a higher risk of marginal bone loss, bleeding on probing, and pocket depth when compared with healthy patients [16]. However, one possible reason for the reduced improvement could also be that the subjects in our study tended to be older. Chan et al. have shown that while continuity of team-based care is associated with a reduction in complications in diabetic patients. The benefits of care may not be as apparent in older patients because they are likely to be in worse health [6]. This may be because such patients tend to have lower oral hygiene awareness and poorer physical recovery than people in the community.

Our study has a few limitations. Compared to CBCT, panoramic radiograph offers a less accurate measurement of alveolar bone level. Although we calibrated the data, some deviations may still exist.

In the future, we should extend the IMB model–based continuity of care to other patients, including those who are not diabetic rather than only those diabetic IOD patients, and continuity of care should accompany with them for the rest of their lives as long as the implant remains in mouth. Our medical care responsibilities not only stay in clinical cooperation with doctors, but also extend to the health maintenance and disease control of patients after discharging from the hospital, and comprehensively improve their recovery and quality of life.

The current study shows that implementing the IMB model-based continuity of care for diabetic IOD patients promotes patient compliance with medication and contributes to improved outcomes in clinical follow-up on PI and bone resorption. Additionally, patients receiving this model of care were more communicative and cooperative with the involved dental technicians and showed greater satisfaction levels than patients who received standard care.

Ethics approval and consent to participat：

All methods of this clinical study were performed in accordance with the relevant guidelines and regulations in compliance with the Declaration of Helsinki. The protocol of this prospective study was reviewed and approved by the Institutional Ethics Committee of Zhejiang University School of Stomatology and Zhejiang Hangzhou Stomatological Hospital (No. 2023 -038) and approved by ClinicalTrials.gov Protocol Registration and Results System (PRS) (No: NCT06103799). Written informed consent was obtained from all participants. Patients signed an informed consent form for the release of their data.

Consent for publication: not applicable

Availability of data and materials:

To protect the privacy rights of patients, we reached a consensus with them in the informed consent form that the clinical data we collected would only be used for specific research purposes and was disclosed. Thus, the data generated during the current study is not publicly available. However, upon reasonable request, we can provide the raw data, please contact Dr. Bai by email ([email protected]).

Competing interests:

There are no competing interests in this paper

Funded by:

Natural Science Foundation of Zhejiang Province (Grant No. LY23H140001)

Author contributions:

Yuliu Lin contributed to conceptualization, data curation, funding acquisition, investigation, methodology, project administration, supervision; Jingyao Bai contributed to the data curation, formal analysis, methodology, supervision, validation, writing – original draft; Chunchun Chen contributed to the data curation, formal analysis, validation, writing – original draft; Yi Zhou contributed to funding acquisition, methodology, resources, writing – review & editing formal analysis; Xiaoxu Guan contributed to the methodology, project administration, resources, writing – review & editing formal analysis.

Acknowledgements

This research was supported by Zhejiang Provincial Natural Science Foundation of China under Grant No.LY23H140001.

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No competing interests reported.

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You are reading this latest preprint version

Application of Information-Motivation-Behavioral model–based Continuity of Care on the Peri-implantitis recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial

Status:

Version 1

Abstract

Aims

Design

Methods

Results

Conclusion

Figures

1. Introduction

2. Materials and Methods

2.1 Design

2.1.1 Inclusion criteria

2.1.2 Exclusion criteria

2.2 Sampling

2.3 Study intervention

2.3.1 Peri-implantitis treatment

2.3.2 Experimental group

2.3.3 Control group intervention methods

2.4 Date collection

2.4.1 Compliance

2.4.2 Patient satisfaction

2.4.3 Plaque index (PI)

2.4.4 Bone loss

2.5 Date analysis

2.6 Ethical considerations

3. Results

4. Discussion

5. Conclusion

Declarations

References

Additional Declarations

Status:

Version 1