Effects of Bio-active Desensitizer on Reduction of Tooth Sensitivity Caused by In-office Bleaching.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorKing Abdullah University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least eight maxillary anterior teeth present.

Age between 18 and 30 years Smokers

The selected teeth has a mean shade of C2 or darker (Vitapan Classical, Vita-Zahnfabrik, Sa¨ckingen, Germany)

Good general and oral health (no visible plaque or gingivitis)

Disqualifiers

Active caries and/or periodontal diseases (gingivitis and recession) or wasting diseases

Smokers

Pregnant/lactating women

Patients who have bleached their teeth previously

Trial design

Design model

Parallel

Treatments tested in this trial

  • Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA)

    Other intervention

    A bioactive desensitizer gel that applied on teeth to reduce tooth sensitivity associated with dental bleaching.

  • Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)

    Other intervention

    Fluoride gel that applied on the teeth to reduce tooth sensitivity

  • Placebo gel without any active ingredients.

    Other intervention

    Water-based glycerin gel is used as the Placebo gel without active ingredients

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: First groupActive comparator 1 intervention
Group B: Second groupActive comparator 1 intervention
Group C: Third groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days, 7 days and 14 days after bleaching.

Secondary outcomes

1

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).

Time frame
Evaluate teeth shade subjectively and objectively after the removal of isolation and after 14 days of bleaching.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.