Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment

Phase 4

Completed

• Conditions: Dentin Sensitivity; Periodontal Diseases
• Interventions: Drug: In-office and at home Colgate sensitive pro-relief - CSPR; Drug: In-office Villevie® prophy paste + Colgate Toothpaste; Procedure: Non-surgical periodontal treatment

• Registration Number: NCT02461030
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks.

Detailed Description

This study aim was to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks. The study was conducted in Piracicaba Dental School, Piracicaba, São Paulo, Brazil, using a double-blind/two treatment design. Sixty subjects (30 per group) that meet the inclusion and exclusion criteria were assigned to the groups: Test group (Non-surgical periodontal treatment + In-office application of Colgate Sensitive Pro-Relief - CSPR + tooth brushing with at home CSPR toothpaste) and Control group (Non-surgical periodontal treatment + In-office application of a fluoride-free prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste). Air blast sensitivity assessments were used to compare the efficacy of the two approaches using both the Schiff scale. The sensitivity parameters were measured at baseline, 1, 4 and 8 weeks.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-02
• Last Update Submitted: 2015-06-02
• Study First Posted: 2015-06-03
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males and females, between 30-75 years of age;
2. Availability for the duration of the study;
3. Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy;
4. Diagnosis, by air blast, of at least two (2) hypersensitive teeth with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale;
5. Subjects in good general health and no allergies to products that are being tested.

Exclusion Criteria

1. Oral pathology, chronic disease, or a history of allergy to testing products;
2. Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures;
3. Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
4. Subject regularly using desensitizing toothpaste;
5. Current smokers;
6. Subject pregnant or breast feeding;
7. Allergies to oral care products, personal care consumer products, or their ingredients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSPR + NS treatment	In-office and at home Colgate sensitive pro-relief - CSPR	In-office and at home Colgate sensitive pro-relief - CSPR Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks.
CSPR + NS treatment	Non-surgical periodontal treatment	In-office and at home Colgate sensitive pro-relief - CSPR Intervention: Non-surgical periodontal treatment (full-mouth debridement, scaling and root planing with ultrasonic/hand instruments) associated with In-office application of Colgate Sensitive Pro-Relief (CSPR) + tooth brushing with at home CSPR toothpaste during 8 weeks.
Villevie® + NS treatment	In-office Villevie® prophy paste + Colgate Toothpaste	In-office Villevie® prophy paste + Colgate Toothpaste Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments)
Villevie® + NS treatment	Non-surgical periodontal treatment	In-office Villevie® prophy paste + Colgate Toothpaste Treatment: In-office application of a Villevie® (fluoride-free) prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste during 8 weeks, after non-surgical periodontal treatment. (Full-mouth debridment/ Scaling and root planing with ultrasonic/hand instruments)

Primary Outcome Measures

Name	Time	Method
Dentin hypersensitivity reduction	Baseline, 8 weeks	Air blast sensitivity assessments using Schiff scale at baseline and up to 8 weeks after non-surgical periodontal treatment.

Secondary Outcome Measures

Name	Time	Method
Probing depth reduction	Baseline, 8 weeks	Full-mouth probing, at baseline and up to 8 weeks after non-surgical periodontal treatment.

Trial Locations

Locations (1)

Piracicaba Dental School, State University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil