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

Primary Purpose

Tooth Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Tri-calcium Phosphate
Placebo
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Sensitivity focused on measuring tooth sensitivity, tri calcium phosphate, at-home whitening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tri-calcium Phosphate

Placebo

Arm Description

clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%

a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%

Outcomes

Primary Outcome Measures

Change in Sensitivity Status
using a visual analog scale (VAS)

Secondary Outcome Measures

Change in Color Shade
color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.

Full Information

First Posted
January 18, 2017
Last Updated
April 11, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03026725
Brief Title
Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide
Official Title
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'
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Sensitivity
Keywords
tooth sensitivity, tri calcium phosphate, at-home whitening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tri-calcium Phosphate
Arm Type
Experimental
Arm Description
clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%
Intervention Type
Other
Intervention Name(s)
Tri-calcium Phosphate
Other Intervention Name(s)
( Clinpro™ Tooth Crème, 3M ESPE, USA
Intervention Description
A paste contains Tri Calcium Phosphate & Fluoride
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
paste manufactured to mimic Clinpro, without Tri Calcium Phosphate
Primary Outcome Measure Information:
Title
Change in Sensitivity Status
Description
using a visual analog scale (VAS)
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
Secondary Outcome Measure Information:
Title
Change in Color Shade
Description
color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.
Time Frame
at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oula Yassin, DDS, MSc,Phd
Organizational Affiliation
Damascus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24147745
Citation
Maghaireh GA, Alzraikat H, Guidoum A. Assessment of the effect of casein phosphopeptide-amorphous calcium phosphate on postoperative sensitivity associated with in-office vital tooth whitening. Oper Dent. 2014 May-Jun;39(3):239-47. doi: 10.2341/12-527-C. Epub 2013 Oct 22.
Results Reference
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PubMed Identifier
26313348
Citation
Loguercio AD, Tay LY, Herrera DR, Bauer J, Reis A. Effectiveness of nano-calcium phosphate paste on sensitivity during and after bleaching: a randomized clinical trial. Braz Oral Res. 2015;29:1-7. doi: 10.1590/1807-3107BOR-2015.vol29.0099. Epub 2015 Aug 21.
Results Reference
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PubMed Identifier
26159384
Citation
Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6. Erratum In: J Dent. 2017 Jul;62:98.
Results Reference
background
PubMed Identifier
21859318
Citation
Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent. 2011 Sep-Oct;36(5):460-6. doi: 10.2341/10-159-C. Epub 2011 Aug 22.
Results Reference
background
PubMed Identifier
22616927
Citation
Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.
Results Reference
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Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide

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