Overview
The study is a prospective single-center, split-mouth randomized controlled trial. 40 patients who are with periodontitis in need of periodontal treatment will be recruited. The assessments, interventions, and follow-ups will be performed at Peking University School and Hospital of Stomatology (Beijing, China). This study has been approved by the ethics committee of Peking University School and Hospital of Stomatology (PKUSSIRB-201734032) and registered in International Clinical Trials Registry Platform (ICTRP) under the identifier number ChiCTR1800017122.
Inclusion criteria
Aggressive periodontitis (AgP): according to the AgP diagnostic criteria established by the international symposium on classification of periodontal diseases in 1999 [26];
1. Aged 18 to 35 years old;
2. Rapid alveolar bone destruction and attachment loss: the probing depth of at least 6 teeth (at least 3 of them are non-first molars and incisors) in the whole mouth is greater than 5mm, and the adjacent attachment loss is greater than 3mm. All are confirmed to have alveolar bone resorption on the adjacent surface by periapical films;
3. There are at least 20 remaining teeth in the whole mouth except the third molars, and at least one molar in each quadrant;
Chronic periodontitis (CP): according to the CP diagnostic criteria established by the international symposium on classification of periodontal diseases in 1999 [26];
1. The patient's onset age is between 35 and 60 years old;
2. The patient is systematically healthy, has gingival bleeding, swelling, pain, halitosis, teeth mobility and occlusion discomfort;
3. At least one molar exists in each quadrant. At least two sites in each quadrant with probing depth greater than 5mm and attachment loss greater than 3mm;
4. At least 50% of all teeth in the whole mouth have the following conditions: (a) there exists sites with probing depth greater than 5mm; (b) alveolar bone absorption is greater than or equal to 30%; (c) bleeding on probing or periodontal abscess;
5. There are at least 20 remaining teeth in the whole mouth except the third molars, and at least one molar in each quadrant.
Exclusion criteria
1. Patients have receive periodontal treatment within 6 months or taken antibacterial drugs within 3 months;
2. Pregnant women or women of child-bearing age who do not take effective contraceptive measures;
3. Systemic diseases such as cardiovascular and endocrine;
4. Allergic to penicillin;
5. Smokers and those who cannot give up alcohol while taking drugs;
6. Patients do not agree to participate in the trial, and do not sign the informed consent.
Recruitment
Subjects who are looking for periodontal treatment and are willing to join this trial will be recruited from Periodontology Department, Peking University School and Hospital of Stomatology. Subjects will receive the study information. Before subject is included in the present study, the consent form must be signed. Figure 1 shows the procedure of participants through this trial.
Groups, randomization, and blinding
An experienced periodontist is going to do the periodontitis disease diagnostic according to clinical and radiographic examination. The randomization sequence and allocation concealment (placed in sealed envelopes) were performed by a professor in the absence of the working investigators, one quadrant of the upper and lower teeth is the test group and the other is the control group. Test group: ultrasonic subgingival scaling combined with manual root planing. Control group: ultrasonic subgingival debridement. All subjects will be treated by one experienced and calibrated therapist who do not partake in the allocation, examination, and statistical analysis. The treatment plan and grouping will be confidential to the examiner and statistical analyst.
Interventions
All enrolled subjects received supragingival scaling with ultrasonic scalers, oral hygiene instruction (OHI) including tooth brushing with modified Bass technique and interdental cleaning with interdental brushes or dental floss. They are submitted to a complete periodontal clinical assessment. Subsequently, the upper and lower teeth of each subject are randomly allocated to the following therapeutic groups: (1) ultrasonic subgingival scaling combined with manual root planing group; (2) ultrasonic subgingival debridement group. The treatment is carried out at the Periodontology Department, Peking University School and Hospital of Stomatology. The treatment is performed by an experienced periodontist who has been calibrated before the trial. The treatment is completed under local anesthesia in two sessions of approximately 1 h, distributed over a period of 7days. Ultrasonic subgingival scaling is performed using magnetostrictive ultrasonic curettes (Dentsply, model number: Gen-130B, 25kHz, America). Manual root planing is performed using Gracey curettes (conventional and mini-fives) numbers 5/6, 7/8, 11/12 and 13/14 (Hu-Friedy, Shanghai, China). At the end of each session, the clinical coordinator evaluates the effectiveness of treatment using the outcome “smoothness of the scaled roots”. All subjects will receive personalized OHI after treatment until the end of the study (24 weeks post-therapy).
Examination
Baseline examination
After the subjects are included, plaque index (PLI), probing depth (PD), clinical attachment loss (CAL), bleeding index (BI), furcation involvement (FI) and mobility are tested before treatment by a calibrated examiner (not the therapist) who has been trained to adequate levels of accuracy and reproducibility.
Examination during the follow-ups
Follow-up
All subjects will be recalled for follow-up at weeks 2, 4, 12 and 24 after the treatment. At weeks 4, 12 and 24 after the treatment, PLI, PD, CAL, BI, FI and mobility will be examined by a calibrated examiner. Any complications will be documented. Besides, subjects will finish a Visual Analogue Scale/Score (VAS) to evaluate pain and sensitivity during the 2 and 4 weeks after treatment.
Primary parameters
The primary parameters of this trial are PD, CAL and BI.
Secondary parameters
The secondary parameters of this trial include PLI, FI, mobility and VAS scale to evaluate pain and sensitivity after treatment.
The sample size of this trial is calculated based on the formula: (see Formula 1 in the Supplementary Files)
According to the preliminary experiment results and data analysis from currently published articles, the difference of PD with and without root planing (δ) is around 0.3 mm and the standard deviation in groups (σ) is around 0.2 mm.
If the inspection level (α) is set at 0.05 and the power of test (β) is set at 90%, then 18 subjects will be required for each group. Given a loss to follow-up is around 10%, this study will require 20 subjects for each group. Consequently, this trial will require at least 40 subjects in all.
Timeline
The recruitment began in October 2018, and the intervention period will be ending in June 2020. Figure 2 shows the schedule of enrollment, intervention, and assessments.
Data collection and management
The data of the patients will be documented both on spreadsheets and databases. The statistical analysis will be performed by two experimenters independently.
Statistical analysis
Shapiro–Wilk test and Levene variance homogeneity test will be performed to test the normality and variance equality, respectively. Continuous normally distributed data will be expressed as mean±standard deviation (SD), and non-normally distributed data as median (lower to upper quartile). Paired-Samples T Test or Two-Related-Samples Test will be used to identify any differences between groups. Statistical significance difference will be set as P value of less than 0.05. Data analyses will be performed by SPSS software.
Ethical considerations
Ethical approval
The trial has been approved by the ethics committee of Peking University School and Hospital of Stomatology (PKUSSIRB-201734032). Before subjects are officially recruited into this study, they will be given a study information and will be asked to sign a consent form.
Withdrawal
Subjects will be informed that they have the right to withdraw from this trial at any time without providing a reason. If the withdrawal occurs, treatment will also be provided to the subject.
Dissemination of results
The results of this trial will be saved at International Clinical Trials Registry Platform (ICTRP) and published in an international peer-reviewed journal which will allow for anyone access to obtain the results.