NCT02461030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
Last Updated

June 3, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

May 28, 2015

Last Update Submit

June 2, 2015

Conditions

Dentin SensitivityPeriodontal Diseases

Keywords

Dentin hypersensitivityPeriodontal diseaseArginine

Outcome Measures

Primary Outcomes (1)

  • Dentin hypersensitivity reduction

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

    Baseline, 8 weeks

Secondary Outcomes (1)

  • Probing depth reduction

    Baseline, 8 weeks

Study Arms (2)

CSPR + NS treatment

EXPERIMENTAL

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 - CSPRProcedure: Non-surgical periodontal treatment

Villevie® + NS treatment

PLACEBO COMPARATOR

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 ToothpasteProcedure: Non-surgical periodontal treatment

Interventions

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

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.

Also known as: CSPR
CSPR + NS treatment
In-office Villevie® prophy paste + Colgate ToothpasteDRUG

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

Also known as: Colgate Cavity Protection Toohtpaste
Villevie® + NS treatment
Non-surgical periodontal treatmentPROCEDURE

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

CSPR + NS treatmentVillevie® + NS treatment

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Dentin SensitivityPeriodontal Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMouth Diseases

Study Officials

  • Enilson A Sallum, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 3, 2015

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-05

Locations

BR(1)