Dentine Hypersensitivity Clinical Trial
Official title:
Comparison of Clinical Efficacy of a Miswak Extract-Containing Toothpaste to a Dentifrice Containing Potassium Nitrate and to a Placebo on Dentinal Hypersensitivity: A Randomized Clinical Trial
The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design. The study designed following the criteria described by Holland et al 1997. The current experiments will follow CONSORT guidelines and will be registered at the US National Institutes of Health (ClinicalTrials.gov). The sensitivity scores will be measured at three intervals: at baseline, at 2 weeks, and at 6 weeks. The duration of the current study estimated to be 6 weeks and will be conducted between January 2020 and March 2020. The study protocol will be submitted initially to the Ethical Committee of the Aseer Central Hospital, Aseer region, Saudi Arabia. After getting the approval and facilitation letters, the participants will be selected randomly from patients attending periodontal clinics at Aseer Dental Center, Aseer region.
Three toothpastes will be investigated during the study period that are 1) commercially
available miswak extract-containing toothpaste; 2) commercially available toothpaste
containing 5% potassium nitrate as positive control; 3) a toothpaste containing the same
formulation as miswak extract except for the active ingredient (miswak extract) as negative
control. Toothpastes will be dispensed in labeled containers named A,B, and C to achieve the
triple masking for investigators, participants, and statisticians. Masked toothpastes will be
revealed to the investigators after the statistical analyses.
After allocation, all subjects will be instructed to refrain from using any desensitizing
agents for two weeks prior to the study up to the end of study period. The randomization
process will be made using SPSS, the function "RAND" to assign every subject to random A, B,
or C masked toothpastes. Moreover, to insure the blinded process of the study we will
dispense the toothpastes in a previously prepared similar containers in separate area. Two
trained examiners will read and record the scores each visit (baseline, 2-weeks, and
6-weeks). For the seek of examiners' calibration, Kappa statistic will be used to assess the
inter-rater reproducibility and we will duplicate a 10% of the study results.
During each visit, teeth around the targeted tooth will be isolated with cotton rolls then
the stimuli will be applied using a sharp dental explorer. It will be passed across the
facial area of the tooth, perpendicular to the tooth long axis. The average of three
consecutive applications will be recorded as a the reading for that tooth.
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