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

NCT ID: NCT04422184

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2023-05-03

Brief Summary

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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

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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).

Conditions

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Dentin Hypersensitivity Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SEN GROUP

Sensodyne Repair and Protect - NOVAMIN technology

Group Type EXPERIMENTAL

Sensodyne Repair and Protect

Intervention Type DRUG

Dentifricie with NOVAMIN technology

REG GROUP

Dentalclean Daily Regenerator - REFIX technology

Group Type EXPERIMENTAL

Dentalclean Daily Regenerator

Intervention Type DRUG

Dentifricie with Refix technology

REGK GROUP

Dentalclean Daily Regenerator - REFIX technology + potassium citrate

Group Type EXPERIMENTAL

Dentalclean Daily Regenerator with potassium citrate

Intervention Type DRUG

Dentifricie with Refix technology+ potassium citrate

Interventions

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Sensodyne Repair and Protect

Dentifricie with NOVAMIN technology

Intervention Type DRUG

Dentalclean Daily Regenerator

Dentifricie with Refix technology

Intervention Type DRUG

Dentalclean Daily Regenerator with potassium citrate

Dentifricie with Refix technology+ potassium citrate

Intervention Type DRUG

Other Intervention Names

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Dentifrice with desensitizing agents Dentifrice with desensitizing agents Dentifrice with desensitizing agents

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mariana Ragghianti Zangrando

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana S Ragghianti Zangrando, Prof

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

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Bauru School of Denstistry

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25495777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25961613 (View on PubMed)

Other Identifiers

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DHPP60

Identifier Type: -

Identifier Source: org_study_id