Clinical trial NCT04422184: Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients
Official title: Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dentin Hypersensitivity
Periodontal Diseases
Keywords: root exposure
periodontal treatment
desensitizing agents.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T1- immediately before scaling and root planing procedures (SRP)
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T2 - immediately after scaling and root planing procedures (SRP)
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T4 - 2 weeks after SRP.
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T5 - 4 weeks after SRP.
measure: Professional evaluation of Dentin Hypersensitivity
timeFrame: T6 - 8 weeks after SRP.
Secondary outcomes:
measure: Patient's perception of DH
timeFrame: T1- immediately before scaling and root planing procedures (SRP)
measure: Patient's perception of DH
timeFrame: T2 - immediately after scaling and root planing procedures (SRP)
measure: Patient's perception of DH
timeFrame: T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
measure: Patient's perception of DH
timeFrame: T4 - 2 weeks after SRP.
measure: Patient's perception of DH
timeFrame: T5 - 4 weeks after SRP.
measure: Patient's perception of DH
timeFrame: T6 - 8 weeks after SRP.
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Denstistry
state: SP
Study officials:
affiliation: USP
name: Mariana S Ragghianti Zangrando, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.