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

Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Dentin Hypersensitivity
• Intervention / Treatment: Drug: Sensodyne Repair and Protect; Drug: Dentalclean Daily Regenerator; Drug: Dentalclean Daily Regenerator with potassium citrate

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Bauru, SP, Brazil, 17012-901
      • Bauru School of Denstistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEN GROUP; Sensodyne Repair and Protect - NOVAMIN technology	Drug: Sensodyne Repair and Protect; Dentifricie with NOVAMIN technology; Other Names: Dentifrice with desensitizing agents
Experimental: REG GROUP; Dentalclean Daily Regenerator - REFIX technology	Drug: Dentalclean Daily Regenerator; Dentifricie with Refix technology; Other Names: Dentifrice with desensitizing agents
Experimental: REGK GROUP; Dentalclean Daily Regenerator - REFIX technology + potassium citrate	Drug: Dentalclean Daily Regenerator with potassium citrate; Dentifricie with Refix technology+ potassium citrate; Other Names: Dentifrice with desensitizing agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional evaluation of Dentin Hypersensitivity	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.	T1- immediately before scaling and root planing procedures (SRP)
Professional evaluation of Dentin Hypersensitivity	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.	T2 - immediately after scaling and root planing procedures (SRP)
Professional evaluation of Dentin Hypersensitivity	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.	T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Professional evaluation of Dentin Hypersensitivity	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.	T4 - 2 weeks after SRP.
Professional evaluation of Dentin Hypersensitivity	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.	T5 - 4 weeks after SRP.
Professional evaluation of Dentin Hypersensitivity	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.	T6 - 8 weeks after SRP.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's perception of DH	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.	T1- immediately before scaling and root planing procedures (SRP)
Patient's perception of DH	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.	T2 - immediately after scaling and root planing procedures (SRP)
Patient's perception of DH	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.	T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Patient's perception of DH	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.	T4 - 2 weeks after SRP.
Patient's perception of DH	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.	T5 - 4 weeks after SRP.
Patient's perception of DH	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.	T6 - 8 weeks after SRP.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mariana S Ragghianti Zangrando, Prof, USP

Publications and helpful links

General Publications

• West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015 Apr;42 Suppl 16:S256-302. doi: 10.1111/jcpe.12336.
• Patil SA, Naik BD, Suma R. Evaluation of three different agents for in-office treatment of dentinal hypersensitivity: a controlled clinical study. Indian J Dent Res. 2015 Jan-Feb;26(1):38-42. doi: 10.4103/0970-9290.156796.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: periodontal treatment; root exposure; desensitizing agents.
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Periodontal Diseases; Physiological Effects of Drugs; Natriuretic Agents; Diuretics; Respiratory System Agents; Expectorants; Potassium Citrate
• Other Study ID Numbers: DHPP60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No