A Randomized Controlled Clinical Trial for the Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients

This randomized controlled clinical trial will be conducted to evaluate of clinical efficacy of TQ gel (5%) as an adjunct to SRP in patients with gingivitis (n=63). The patients will be recruited from the Faculty of Dentistry, Qassim University and the subjects will be divided into three groups and include Group I (SRP+TQ gel), Group II (SRP+Placebo), and Group III (Only SRP-one stage prophylaxis). The subjects will be given an explanation of the purpose of the study; informed consent will be obtained in a written format. This clinical trial will be performed in accordance with the ICH (International Conference on Harmonization-E6 'Guideline for Good Clinical Practice') and Helsinki Declaration 1975, as revised in 2000. The study protocol was approved by the Institutional Review Board, Qassim University, Saudi Arabia (IRB No: EAC 104-2018). The complete oral diagnosis will be performed during the screening visit by clinical assessment and periapical radiographs may be indicated to obtain a definitive diagnosis, The periodontal charting will be performed and recorded in the patient's case record. The participants will be consecutively enrolled with the following inclusion and exclusion criteria.

Preparation of Lipid-based TQ gel formulation (5%):

Thymoquinone extract (Sigma Aldrich extract-Product No:03416) was obtained in crystalline form.

Mode of Administration In Group I patients, the lipid-based TQ gel (5%) will be applied topically to the affected areas, twice daily for two weeks following SRP. The investigator will perform the treatment of gingivitis based on the patient's response to therapy. For home care, the patients will be instructed to clean and dry the affected area prior to the gel application and hands to be washed prior to and after its application. The patients would be instructed to not eat for 30 minutes following its application. The same will be done for Group II patients who were treated with SRP followed by a placebo gel application in the affected areas. The Group III patients will be subjected to one-stage oral prophylaxis. It will be a double-blinded clinical trial as the patients would not be made aware of which gel preparation was given to them and the principal investigators would not be aware of the patient's group while performing clinical measurements, whereas the operator performed SRP and gel application.

Treatment Compliance A diary card will be given to all the patients along with instructions on filling the card and reminders to bring it on subsequent visits will be mentioned. The principal investigator will ensure that each patient used at least 75% and not more than 125% of the study drug over the course of the study period. The drug accountability i.e., receipt, dispensing, and return of the drug) will be performed either by the principal investigator or his designee. The assessment of the primary endpoint will be based on the clinical scoring conducted on a weekly basis till the end of the study.