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

U

University of Sao Paulo

Status and phase

Completed
Phase 4

Conditions

Periodontal Diseases
Dentin Hypersensitivity

Treatments

Drug: Sensodyne Repair and Protect
Drug: Dentalclean Daily Regenerator
Drug: Dentalclean Daily Regenerator with potassium citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04422184
DHPP60

Details and patient eligibility

About

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.

Full 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).

Enrollment

33 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

33 participants in 3 patient groups

SEN GROUP
Experimental group
Description:
Sensodyne Repair and Protect - NOVAMIN technology
Treatment:
Drug: Sensodyne Repair and Protect
REG GROUP
Experimental group
Description:
Dentalclean Daily Regenerator - REFIX technology
Treatment:
Drug: Dentalclean Daily Regenerator
REGK GROUP
Experimental group
Description:
Dentalclean Daily Regenerator - REFIX technology + potassium citrate
Treatment:
Drug: Dentalclean Daily Regenerator with potassium citrate

Trial contacts and locations

1

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Central trial contact

Giovana Favero; Mariana S Ragghianti Zangrando, Prof

Data sourced from clinicaltrials.gov

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