NCT03026725

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

January 18, 2017

Last Update Submit

April 11, 2017

Conditions

Tooth Sensitivity

Keywords

tooth sensitivitytri calcium phosphateat-home whitening

Outcome Measures

Primary Outcomes (1)

  • Change in Sensitivity Status

    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 Outcomes (1)

  • Change in Color Shade

    at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application

Study Arms (2)

Tri-calcium Phosphate

EXPERIMENTAL

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

Other: Tri-calcium Phosphate

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tri-calcium PhosphateOTHER

A paste contains Tri Calcium Phosphate \& Fluoride

Also known as: ( Clinpro™ Tooth Crème, 3M ESPE, USA
Tri-calcium Phosphate
PlaceboOTHER

paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

  • 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.

    PMID: 24147745BACKGROUND

  • 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.

    PMID: 26313348BACKGROUND

  • 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.

    PMID: 26159384BACKGROUND

  • 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.

    PMID: 21859318BACKGROUND

  • 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.

    PMID: 22616927BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Oula Yassin, DDS, MSc,Phd

    Damascus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

November 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)