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

NCT ID: NCT02461030

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Dentin Sensitivity; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CSPR + NS 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.

Group Type: EXPERIMENTAL

In-office and at home Colgate sensitive pro-relief - CSPR

Intervention Type: DRUG

Prophylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments

Villevie® + NS 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)

Group Type: PLACEBO_COMPARATOR

In-office Villevie® prophy paste + Colgate Toothpaste

Intervention Type: DRUG

Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments

Interventions

In-office and at home Colgate sensitive pro-relief - CSPR

Prophylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.

Intervention Type: DRUG

In-office Villevie® prophy paste + Colgate Toothpaste

Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.

Intervention Type: DRUG

Non-surgical periodontal treatment

Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments

Intervention Type: PROCEDURE

Other Intervention Names

CSPR; Colgate Cavity Protection Toohtpaste

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Enilson Antonio Sallum

Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enilson A Sallum, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, Brazil

Countries

Brazil

Other Identifiers

058/2013

Identifier Type: -

Identifier Source: org_study_id