Effects of Bio-active Desensitizer on Reduction of Tooth Sensitivity Caused by In-office Bleaching.
NCT Number: NCT06532526
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Discoloration
Interventions: OTHER: Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA)|OTHER: Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)|OTHER: Placebo gel without any active ingredients.
Sponsor: King Abdullah University Hospital
Sex: ALL
Age: ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-04-01
Locations: Jordan University of Science and Technology, Irbid, P.O.Box 3030, Jordan

Summary:
The main aim of this randomized controlled clinical trial is to evaluate the efficacy of a bioactive glass desensitizer in reducing tooth sensitivity associated with in-office vital tooth bleaching. In addition, this study aims to compare the effectiveness of the bioactive glass desensitizer with that of a fluoride gel and a gel without desensitizing agent with regard to incidence, intensity, and duration of tooth sensitivity and, finally, to investigate how these agents affect tooth-shade following in-office bleaching. The hypothesis of the study is: There will be no difference in the effect of a bio-active glass desensitizer on tooth sensitivity associated with vital in-office tooth bleaching compared to a fluoride gel and the bio-active glass desensitizer has no effect on the bleaching efficacy.

Primary Outcome Measures: Tooth sensitivity associated with vital in-office tooth bleaching, Tooth sensitivity associated with vital in-office tooth bleaching using the the five-point Numeric Rating Scale (NRS):

0: No sensitivity

1. Mild sensitivity,
2. Moderate sensitivity
3. Considerable sensitivity
4. Severe sensitivity Also, sensitivity will be evaluated using the visual analog scale of pain (VAS). The VAS is a horizontal line containing 10 numbers from 0 to 10; zero indicates no pain and 10 indicates the worst pain. Participants will be asked to mark the number that indicated their level of pain. The participants will be asked to record the stimulus that caused sensitivity, including hot, cold, or other. The duration of pain, whether seconds, minutes, or hours, will be recorded for the 14-day follow-up period. For descriptive analysis purposes, the intensity results will be categorized according to the following scale: 0 = none, 1-3 = mild, 4-6 = moderate, and 7-10 = severe., Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days, 7 days and 14 days after bleaching.
Secondary Outcome Measures: Efficacy of bleaching, Lightening of the teeth shade with in-office tooth bleaching. Subjectively it will be evaluated using VITA classical shade guide which has 16 tabs ranging from B1 (lightest value) to C4 (darkest value) by matching the color with the middle third of the maxillary anterior teeth. One evaluator will record the shade of the participants' teeth at baseline (before whitening), directly after bleaching, and at days 3, 7, and 14 days follow up periods. Photographs will be taken using a digital camera immediately after the whitening and at each shade evaluation to document results. Also, teeth shade will be evaluated objectively using VITA easy shade spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany)., Evaluate teeth shade subjectively and objectively after the removal of isolation and after 14 days of bleaching.