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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

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
Probing depth reduction [ Time Frame: Baseline, 8 weeks ]
Full-mouth probing, at baseline and up to 8 weeks after non-surgical periodontal treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dentin Sensitivity
  • Periodontal Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: In-office and at home Colgate sensitive pro-relief - CSPR
    • Procedure: Non-surgical periodontal treatment
  • 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)

    Interventions:
    • Drug: In-office Villevie® prophy paste + Colgate Toothpaste
    • Procedure: Non-surgical periodontal treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2015)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02461030
Other Study ID Numbers  ICMJE 058/2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enilson Antonio Sallum, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Colgate Palmolive
Investigators  ICMJE
Principal Investigator: Enilson A Sallum, PhD University of Campinas, Brazil
PRS Account University of Campinas, Brazil
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP