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

Not Applicable

Completed

• Conditions: Tooth Sensitivity
• Interventions: Other: Tri-calcium Phosphate; Other: Placebo

• Registration Number: NCT03026725
• Lead Sponsor: Damascus University

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,

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tri-calcium Phosphate	Tri-calcium Phosphate	clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%
Placebo	Placebo	a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%

Primary Outcome Measures

Name	Time	Method
Change in Sensitivity Status	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	using a visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
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	color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic