Clinical trial NCT03026725: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Sensitivity
Keywords: tooth sensitivity
tri calcium phosphate
at-home whitening
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,

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

Primary outcomes:
measure: Change in Sensitivity Status
timeFrame: 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:
measure: Change in Color Shade
timeFrame: at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Damascus University
name: Oula Yassin, DDS, MSc,Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.