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

NCT06532526 | Recruiting

• 1 other identifier: 886-2023
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Discoloration

Keywords

Sensitivity; Bio-active desensitizer; in-office bleaching

Outcome Measures

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.

  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

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

Study Arms (3)

First group

ACTIVE COMPARATOR

Predicat Bioactive desensitizer

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

Second group

ACTIVE COMPARATOR

Gel with 1.23% sodium fluoride

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

Third group

PLACEBO COMPARATOR

Placebo gel

Other: Placebo gel without any active ingredients.

Interventions

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

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

First group

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

Fluoride gel that applied on the teeth to reduce tooth sensitivity

Second group

Placebo gel without any active ingredients. OTHER

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

Third group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• No restorations or carious lesions on the buccal surfaces of the anterior teeth to be whitened
• No history of tooth sensitivity
• No use of a desensitizing agent or desensitizing toothpaste in the past six months

You may not qualify if:

• Active caries and/or periodontal diseases (gingivitis and recession) or wasting diseases
• Smokers
• Pregnant/lactating women
• Patients who have bleached their teeth previously
• No schedule availability

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, P.O.Box 3030, Jordan

RECRUITING

Related Publications (1)

• Maghaireh GA, Alzraikat H, Altarazi MY. Effects of a bioactive desensitizing material on in-office bleaching-induced tooth sensitivity: A randomized double-blind controlled trial. J Dent. 2026 Jan 1;166:106326. doi: 10.1016/j.jdent.2025.106326. Online ahead of print.

  PMID: 41483835 DERIVED

MeSH Terms

Conditions

Tooth Discoloration; Hypersensitivity

Interventions

Gels; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ghada A Maghaireh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada A Maghaireh

CONTACT

0798809296; gmaghair@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants as well as the evaluators will be informed about the nature and objectives of the study; however, they will not be informed what desensitizing material they would receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The study will be a double blinded (Patient and evaluator) randomized clinical trial with a sample size of 51, 17 participants for each group (n=17).

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: April 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)