Tooth DiscolorationNCT06532526
Effects of Bio-active Desensitizer on Reduction of Tooth Sensitivity Caused by In-office Bleaching.
A study testing Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA) and Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA) in people with Tooth Discoloration, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA) and Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, P.O.Box 3030
Ghada A Maghaireh, 0798809296, gmaghair@just.edu.jo
Hanan J AL-Zriqat
About this study
Official title: Assessment of the Effects of Bio-active Desensitizing Materials on the Bleaching Efficacy and Reduction of Tooth Sensitivity Caused by Vital In-office Bleaching: A Randomized Controlled Clinical 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.
Read the detailed description
The participants will be informed about the nature and objectives of the study; however, they will not be informed what desensitizing material they would receive. 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). Bleaching process: A lip and cheek retractor will be placed. The gingival tissues from the right first molar to the left first molar will be isolated using a light-cured resin dam to prevent the whitening gel from coming into contact with the gingival tissue. Participants' lips will be painted with Vaseline, and protective eyewear will be used. To aid in the isolation process, a plastic suction tip with high suction power will be used. Opalescence Boost in Office Whitening Gel, 40% Hydrogen Peroxide bleaching material (Ultradent Products, South Jordan, UT, USA) will be applied directly on the labial tooth surface from the right first premolar to the left first premolar. A total of three (20-minute) applications will be completed in each bleaching session. Participants will undergo 2 bleaching sessions with one-week interval. Participants will be scheduled for lower arch whitening after 14 days.
Application of the desensitizer: The participants will be assigned randomly to three study groups. The first group will receive a bio active desensitizer, the second group will receive a fluoride gel and the third group will receive a placebo gel without a desensitizer (Table 2). A small amount of the gel assigned for each participant will be applied directly on the labial surface of each tooth and left undisturbed for three minutes; care will be taken to cover the entire labial surface, and the gel will be carried interproximally as much as possible.
Shade evaluation: Teeth shade will be evaluated subjectively and objectively. 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). The tooth must be well hydrated before analyzing the tooth color. The shade of the teeth in VITA classical A1-D4 and VITA 3D-MASTER shades will be instantly measured and displayed on the screen. One evaluator will record the shade of the teeth and the shade will be recorded at baseline, immediately after bleaching and at 3, 7 and 14 days follow up periods. Sensitivity Evaluation: Post-bleaching sensitivity will be evaluated by relying on patient's feeling of pain.
Sensitivity evaluation: All participants will be given a sensitivity sheet to record the post-whitening sensitivity of the whitened teeth on daily basis up to 14 days according to the visual analog scale of pain (VAS). 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.
- Conditions
- Tooth Discoloration
- Being tested
- Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA), Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA), Placebo gel without any active ingredients.
- Keywords
- Sensitivity, Bio-active desensitizer, in-office bleaching
- Medical subject headings
- Tooth Discoloration, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)Other
Fluoride gel that applied on the teeth to reduce tooth sensitivity
Placebo gel without any active ingredients.Other
Water-based glycerin gel is used as the Placebo gel without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | Predicat Bioactive desensitizer Receives: Other: Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA) |
| Second group | Active comparator | Gel with 1.23% sodium fluoride Receives: Other: Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA) |
| Third group | Placebo comparator | Placebo gel Receives: Other: Placebo gel without any active ingredients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Mild sensitivity,
- Moderate sensitivity
- Considerable sensitivity
- 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.
Measured: 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).
Measured: Evaluate teeth shade subjectively and objectively after the removal of isolation and after 14 days of bleaching.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Maghaireh, King Abdullah University Hospital
- Investigators
- Ghada A Maghaireh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532526
- Sponsor's protocol ID
- 886-2023
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Mar;166:106326. doi: 10.1016/j.jdent.2025.106326. Epub 2026 Jan 1.
PubMed 41483835
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Bio-active Desensitizing Materials on the Bleaching Efficacy and Reduction of Tooth Sensitivity Caused by Vital In-office Bleaching: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06532526
- Acronym / sponsor ID
- 886-2023
- Conditions
- Tooth Discoloration
- Keywords
- Sensitivity, Bio-active desensitizer, in-office bleaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The participants will be informed about the nature and objectives of the study; however, they will not be informed what desensitizing material they would receive. 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). Bleaching process: A lip and cheek retractor will be placed. The gingival tissues from the right first molar to the left first molar will be isolated using a light-cured resin dam to prevent the whitening gel from coming into contact with the gingival tissue. Participants' lips will be painted with Vaseline, and protective eyewear will be used. To aid in the isolation process, a plastic suction tip with high suction power will be used. Opalescence Boost in Office Whitening Gel, 40% Hydrogen Peroxide bleaching material (Ultradent Products, South Jordan, UT, USA) will be applied directly on the labial tooth surface from the right first premolar to the left first premolar. A total of three (20-minute) applications will be completed in each bleaching session. Participants will undergo 2 bleaching sessions with one-week interval. Participants will be scheduled for lower arch whitening after 14 days.
Application of the desensitizer: The participants will be assigned randomly to three study groups. The first group will receive a bio active desensitizer, the second group will receive a fluoride gel and the third group will receive a placebo gel without a desensitizer (Table 2). A small amount of the gel assigned for each participant will be applied directly on the labial surface of each tooth and left undisturbed for three minutes; care will be taken to cover the entire labial surface, and the gel will be carried interproximally as much as possible.
Shade evaluation: Teeth shade will be evaluated subjectively and objectively. 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). The tooth must be well hydrated before analyzing the tooth color. The shade of the teeth in VITA classical A1-D4 and VITA 3D-MASTER shades will be instantly measured and displayed on the screen. One evaluator will record the shade of the teeth and the shade will be recorded at baseline, immediately after bleaching and at 3, 7 and 14 days follow up periods. Sensitivity Evaluation: Post-bleaching sensitivity will be evaluated by relying on patient's feeling of pain.
Sensitivity evaluation: All participants will be given a sensitivity sheet to record the post-whitening sensitivity of the whitened teeth on daily basis up to 14 days according to the visual analog scale of pain (VAS). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| First group | Active comparator | Other: Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA)Predicat Bioactive desensitizer |
| Second group | Active comparator | Other: Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)Gel with 1.23% sodium fluoride |
| Third group | Placebo comparator | Other: Placebo gel without any active ingredients.Placebo gel |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA)A bioactive desensitizer gel that applied on teeth to reduce tooth sensitivity associated with dental bleaching. | Other | First group |
| Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA)Fluoride gel that applied on the teeth to reduce tooth sensitivity | Other | Second group |
| Placebo gel without any active ingredients.Water-based glycerin gel is used as the Placebo gel without active ingredients | Other | Third group |
Primary outcome
Tooth sensitivity associated with vital in-office tooth bleaching
Time frame: Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days, 7 days and 14 days after 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.
1 secondary outcome
Efficacy of bleaching
Time frame: Evaluate teeth shade subjectively and objectively after the removal of isolation and after 14 days of bleaching.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 41483835Maghaireh 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 Mar;166:106326. doi: 10.1016/j.jdent.2025.106326. Epub 2026 Jan 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada A Maghaireh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predicta® Bioactive Desensitizer (PBD, PARKELL, EDGEWOOD, NY, USA) and Gel with 1.23% sodium fluoride (EAZIGEL, VERICOM CO., LTD. SOUTH KOREA) in people with Tooth Discoloration, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada A Maghaireh (0798809296, gmaghair@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth sensitivity associated with vital in-office tooth bleaching (time frame: Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days, 7 days and 14 days after bleaching.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06532526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.