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.
Aggressive periodontitis (AgP): according to the AgP diagnostic criteria established by the international symposium on classification of periodontal diseases in 1999 ;
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 were confirmed to have alveolar bone resorption on the adjacent surface by periapical films;
3. The participant did not receive periodontal treatment within 6 months before treatment, and did not take antibacterial drugs for nearly 3 months;
4. There are at least 20 remaining teeth in the whole mouth except the third molars, and at least one molar in each section;
Chronic periodontitis (CP): according to the CP diagnostic criteria established by the international symposium on classification of periodontal diseases in 1999 ;
1. The patient’s onset age was between 35 and 60 years old;
2. The patient was systematically healthy, had gingival bleeding, swelling, pain, halitosis, teeth mobility and occlusion discomfort;
3. At least one molar exists in each section. 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. The participant did not receive periodontal treatment within 6 months before treatment, and did not take antibacterial drugs for nearly 3 months;
6. There are at least 20 remaining teeth in the whole mouth except the third molars, and at least one molar in each section.
1. Patients have 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 test, and do not sign the informed consent.
Subjects will be recruited from Peking University School and Hospital of Stomatology. Subjects who are willing to join this trial 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
Through randomization tables, 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. The therapist will not partake in the statistical analysis. The treatment plan and grouping will be confidential to the examiner and statistical analyst.
Test group: ultrasonic subgingival scaling combined with manual root planing.
Control group: ultrasonic subgingival debridement.
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 the examiner (not the therapist).
The primary parameters of this trial are PD, CAL and BI.
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: . According to the preliminary experiment results and data analysis from currently published articles, the difference of PD with and without root planning (δ) is around 0.5 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.
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.
Shapiro–Wilk test and Levene variance homogeneity test were performed to test the normality and variance equality, respectively. Continuous normally distributed data were 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 were 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.
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.
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.