Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients

Phase 4

Completed

• Conditions: Dentin Hypersensitivity; Periodontal Diseases
• Interventions: Drug: Sensodyne Repair and Protect; Drug: Dentalclean Daily Regenerator; Drug: Dentalclean Daily Regenerator with potassium citrate

• Registration Number: NCT04422184
• Lead Sponsor: University of Sao Paulo

Brief Summary

The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. The evaluation will be in 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Profissional assessments and patient perception data will be performed.

Detailed Description

Periodontal patients may report dentinal hypersensitivity (DH) caused by root surface exposure as part of disease process or as a result of periodontal treatment. Although some studies evaluated DH reduction using desensitizing toothpastes, no specific chemical/physical agent is reported for periodontal patients. Thus, the present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. This randomized, parallel and blinded clinical trial will be divided into 3 groups (SEN GROUP: Sensodyne; REG GROUP: Regenerator; REGK GROUP: Regenerator + Potassium Citrate) and evaluated at 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Air blast sensitivity assessments (Schiff scale) and patient perception data on DH will be performed using visual analog scales (VAS). The comparison between treatment groups will be done by paired T-test if normal distribution is observed or Wilcoxon if non-normal distribution. The significance level adopted will be 5% (p \<0.05).

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Status Verified: 2023-05
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-03
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• patients diagnosed with periodontitis
• 18 to 70 years old
• systemically healthy
• without any allergy to the dentifrices components
• patients who needed scaling and root planing procedures
• patients who had at least 2 teeth with DH (incisors, canines or premolars).

Exclusion Criteria

• pregnancy
• patients in orthodontic treatment
• patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
• patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEN GROUP	Sensodyne Repair and Protect	Sensodyne Repair and Protect - NOVAMIN technology
REG GROUP	Dentalclean Daily Regenerator	Dentalclean Daily Regenerator - REFIX technology
REGK GROUP	Dentalclean Daily Regenerator with potassium citrate	Dentalclean Daily Regenerator - REFIX technology + potassium citrate

Primary Outcome Measures

Name	Time	Method
Professional evaluation of Dentin Hypersensitivity	T6 - 8 weeks after SRP.	Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

Secondary Outcome Measures

Name	Time	Method
Patient's perception of DH	T6 - 8 weeks after SRP.	Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.

Trial Locations

Locations (1)

Bauru School of Denstistry; 🇧🇷 Bauru, SP, Brazil