Randomized Clinical Trial and Comparison of Propolis With Sodium Fluoride and Acidulated Phosphate Fluoride Using Iontophoresis as a Treatment for Cervical Dentin Hypersensitivity

Preparation of the materials 10 milligrams of Sodium Fluoride powder was mixed with 500 ml of distilled water to attain 500 ml of 2% concentrated Sodium Fluoride solution. Commercially available Acidulated Phosphate Fluoride was used at 1.23% concentration. Preparation of propolis: Commercially available raw Indian propolis in wax form was obtained from Hi-Tech Natural Product India Limited, New Delhi, India. 10% propolis was prepared after mixing with of 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in a dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper (Whatman International Ltd. England) to remove impurities. Propolis in general is fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol-based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in the dark amber-colored bottle without any preservatives.

Study Design The trial was designed after multiple discussions among the authors and strictly followed the guidelines of CONSORT (Consolidated standards of reporting trials). It was a single centered, parallel, and double-blinded randomized clinical trial, approved by an institutional ethical review board and thesis protocol was registered in concerned medical university. Centralized computer-generated randomization was done without any restrictions. Randomization codes were kept sealed and managed by the central pharmacy to follow the allocation concealment. The DH measurements were performed by two blinded examiners (NMB and NRR), and averages were noted at each time interval. Each time, while checking, a new sheet of paper was given to the examiners to record the measurements, and to hide the old measures, to prevent bias. Interventions were carried out by another blinded author (TS). Cronbach's Alpha for inter-examiner reliability was found to be 0.92 and intra-examiner reliability 0.85 and 0.82 for examiner 1 and 2 respectively.

Study Participants Consecutive patients who visited the Department of Periodontology; from April 2019 to August 2020, with the DH as a chief complaint, with an age range of 25-60 years were invited to join in the study. Participating in the study was purely voluntary. Written informed consent was taken from each patient. The willing patients were assessed for following the necessary eligibility criteria.

Patients included were: Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as >1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars. However, patients excluded were: Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.

Patients were allocated to three test groups after randomization. Oral prophylaxis was done in all three groups; baseline DH levels were then evaluated.