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

NCT ID: NCT03026725

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

Brief Summary

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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

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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,

Conditions

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Tooth Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tri-calcium Phosphate

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

Group Type EXPERIMENTAL

Tri-calcium Phosphate

Intervention Type OTHER

A paste contains Tri Calcium Phosphate \& Fluoride

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

Interventions

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Tri-calcium Phosphate

A paste contains Tri Calcium Phosphate \& Fluoride

Intervention Type OTHER

Placebo

paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

Intervention Type OTHER

Other Intervention Names

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( Clinpro™ Tooth Crème, 3M ESPE, USA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oula Yassin, DDS, MSc,Phd

Role: PRINCIPAL_INVESTIGATOR

Damascus University

Locations

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Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 24147745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26313348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26159384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21859318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22616927 (View on PubMed)

Other Identifiers

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UDDS-OperDent-03-2016

Identifier Type: -

Identifier Source: org_study_id

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