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

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Dentin Sensitivity; Periodontal Diseases

Treatments: Drug: In-office and at home Colgate sensitive pro-relief - CSPR; Drug: In-office Villevie® prophy paste + Colgate Toothpaste; Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02461030

058/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

CSPR + NS treatment

Experimental group

Description:

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.

Treatment:

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

Procedure: Non-surgical periodontal treatment

Villevie® + NS treatment

Placebo Comparator group

Description:

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)

Treatment:

Drug: In-office Villevie® prophy paste + Colgate Toothpaste

Procedure: Non-surgical periodontal treatment