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CompletedNCT03026725Updated Apr 13, 2017

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

An interventional study of Tri-calcium Phosphate and Placebo in Tooth Sensitivity, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-13.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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,

02

Conditions studied

  • Tooth Sensitivity

Keywords

  • tooth sensitivity
  • tri calcium phosphate
  • at-home whitening
03

In context

Dentin Sensitivity

283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherTri-calcium Phosphate

    A paste contains Tri Calcium Phosphate \& Fluoride

    Also known as: ( Clinpro™ Tooth Crème, 3M ESPE, USA

  • OtherPlacebo

    paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

06

What researchers measure

Primary outcomes

  1. Change in Sensitivity Status

    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 outcomes

  1. Change in Color Shade

    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

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Study locations

1 site
  • Damascus University
    Damascus, Syrian Arab Republic
08

References and documents

Publications

  • 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. PubMed 24147745 ↗
  • 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. PubMed 26313348 ↗
  • 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. doi: 10.1016/j.jdent.2017.05.019. PubMed 26159384 ↗
  • 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. PubMed 21859318 ↗
  • 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. PubMed 22616927 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03026725
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Jan 20, 2017
Start date
Nov 2016
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Apr 13, 2017

Study contacts

Oula Yassin, DDS, MSc,Phd
principal investigator · Damascus University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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