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

Tooth Sensitivity Clinical Trial

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026725
• Other study ID #: UDDS-OperDent-03-2016
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: April 11, 2017
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Sensitivity

Intervention

Other:
• Tri-calcium Phosphate
A paste contains Tri Calcium Phosphate & Fluoride
• Placebo
paste manufactured to mimic Clinpro, without Tri Calcium Phosphate

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

Basting RT, Amaral FL, França FM, Flório 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. — View 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. — View 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. — View 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. — View 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):1099-105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Color Shade	color shade change will be detected; using Vita Easy Shade? Advance 4.0.	at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application