Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide

April 11, 2017 updated by: Damascus University

Effect of Tri Calcium Phosphate Paste on Efficacy and Postoperative Sensitivity Associated With At-Home Vital Tooth Whitening Using 20% Carbamide Peroxide 'A Randomized Controlled Study'

Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good dental health
  • Six maxillary anterior teeth present and healthy with no restorations or carious lesions
  • Teeth darker than Vita A2 shade
  • No history of teeth sensitivity
  • No use of a desensitizing agent or desensitizing toothpaste in the past three months

Exclusion Criteria:

  • Active caries or periodontal disease
  • Allergies to bleaching agent or tray material
  • pregnancy and breastfeeding during the trial
  • tetracycline-stained teeth or fluoride or non-vital teeth
  • Smoker
  • Using tooth bleaching products during the last 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tri-calcium Phosphate
clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%
Other: Tri-calcium Phosphate
A paste contains Tri Calcium Phosphate & Fluoride
Other Names:
  • ( Clinpro™ Tooth Crème, 3M ESPE, USA
PLACEBO_COMPARATOR: Placebo
a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%
Other: Placebo
paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sensitivity Status
Time Frame: at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application
using a visual analog scale (VAS)
at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Color Shade
Time Frame: at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application
color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.
at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Oula Yassin, DDS, MSc,Phd, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OperDent-03-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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