Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity

Not Applicable

• Conditions: Dentine Hypersensitivity
• Interventions: Other: Miswak extract-containing toothpaste; Other: Potassium nitrates-containing toothpaste; Other: Placebo

• Registration Number: NCT04179994
• Lead Sponsor: Ministry of Health, Saudi Arabia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-29
• Study Start: 2020-01-01
• Primary Completion: 2020-04-25
• Study Completion: 2020-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Subjects with history of DH caused by cervical erosion or gingival recession
• Subjects show good general health
• Must have at least two teeth with VAS score of 4 or more

Exclusion Criteria

• Subjects have teeth with caries, occlusal restorations, or orthodontic appliances
• Subjects allergic to ingredients used in the study
• Subjects present any oral pathology, eating disorders, chronic disease, or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miswak extract-containing toothpaste group	Miswak extract-containing toothpaste	Test group.
Toothpaste containing Potassium Nitrates	Potassium nitrates-containing toothpaste	Positive control.
Placebo group	Placebo	Toothpaste contains same ingredients of test group except for the active ingredient as negative control.

Primary Outcome Measures

Name	Time	Method
Pain reduction	6 weeks period	Visual Analog Scale (VAS) will be used to measure pain intensity. The scale is graded from 1 to 10 with zero score indicates a pain-free response and 10 indicates sever pain or discomfort.