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

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ClinicalTrials.gov Identifier: NCT02461030
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Enilson Antonio Sallum, 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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Periodontal Diseases Drug: In-office and at home Colgate sensitive pro-relief - CSPR Drug: In-office Villevie® prophy paste + Colgate Toothpaste Procedure: Non-surgical periodontal treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: 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 Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: 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.
Other Name: CSPR

Procedure: Non-surgical periodontal treatment
Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments

Placebo Comparator: 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)

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.
Other Name: Colgate Cavity Protection Toohtpaste

Procedure: Non-surgical periodontal treatment
Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments




Primary Outcome Measures :
  1. Dentin hypersensitivity reduction [ Time Frame: 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 :
  1. Probing depth reduction [ Time Frame: Baseline, 8 weeks ]
    Full-mouth probing, at baseline and up to 8 weeks after non-surgical periodontal treatment.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461030


Locations
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Brazil
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Colgate Palmolive
Investigators
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Principal Investigator: Enilson A Sallum, PhD University of Campinas, Brazil

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Responsible Party: Enilson Antonio Sallum, Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02461030     History of Changes
Other Study ID Numbers: 058/2013
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015
Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Dentin hypersensitivity
Periodontal disease
Arginine
Additional relevant MeSH terms:
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Periodontal Diseases
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Listerine
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents