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

Primary Purpose

Dentin Sensitivity, Periodontal Diseases

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
In-office and at home Colgate sensitive pro-relief - CSPR
In-office Villevie® prophy paste + Colgate Toothpaste
Non-surgical periodontal treatment
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Dentin hypersensitivity, Periodontal disease, Arginine

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Piracicaba Dental School, State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CSPR + NS treatment

Villevie® + NS treatment

Arm 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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2015
Last Updated
June 2, 2015
Sponsor
University of Campinas, Brazil
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT02461030
Brief Title
Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment
Official Title
An 8-Week Clinical Study to Evaluate the Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Non-surgical Periodontal Treatment: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Colgate Palmolive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity, Periodontal Diseases
Keywords
Dentin hypersensitivity, Periodontal disease, Arginine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSPR + NS treatment
Arm Type
Experimental
Arm 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.
Arm Title
Villevie® + NS treatment
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
In-office and at home Colgate sensitive pro-relief - CSPR
Other Intervention Name(s)
CSPR
Intervention Description
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
Intervention Name(s)
In-office Villevie® prophy paste + Colgate Toothpaste
Other Intervention Name(s)
Colgate Cavity Protection Toohtpaste
Intervention Description
Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments
Primary Outcome Measure Information:
Title
Dentin hypersensitivity reduction
Description
Air blast sensitivity assessments using Schiff scale at baseline and up to 8 weeks after non-surgical periodontal treatment.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Probing depth reduction
Description
Full-mouth probing, at baseline and up to 8 weeks after non-surgical periodontal treatment.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, between 30-75 years of age; Availability for the duration of the study; Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy; 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; Subjects in good general health and no allergies to products that are being tested. Exclusion Criteria: Oral pathology, chronic disease, or a history of allergy to testing products; Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures; 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; Subject regularly using desensitizing toothpaste; Current smokers; Subject pregnant or breast feeding; Allergies to oral care products, personal care consumer products, or their ingredients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enilson A Sallum, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

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

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