Tooth DiscolorationNCT06700434
Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide
A study testing Bleaching treatment in people with Tooth Discoloration, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide. Read more about this study
- Who is it for?
- Ages 21 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Bleaching treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 15 Mar 2024
- 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 21 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men (at least 18 years old)
- People with good oral and general health
- People without periodontal disease
- Teeth without caries
- Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)
Who cannot join
- Having undergone teeth bleaching procedure in the last 2 years,
- People with tooth sensitivity,
- Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
- People with gingival recession,
- Discoloration due to parafunction, tetracycline or fluorosis,
- Smokers,
- Tooth fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial
Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.
Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.
- Conditions
- Tooth Discoloration
- Being tested
- Bleaching treatment
- Keywords
- Hydrogen Peroxide, In-office bleaching, Randomized clinical trial, Tooth sensitivity, Whitening effectiveness, Quality of life
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching treatmentOther
After the lip retractor (OptraGate, Ivoclar Vivadent, Schaan, Liechtenstein) was placed, the gingival barrier protection (Biowhiten, Biodent Ltd., İstanbul, Turkey) included in the products was applied to the upper and lower arches from premolar to premolar at the beginning of each session and removed after each treatment. The bleaching gels were applied according to the manufacturer and removed after the recommended period with a disposable surgical saliva ejector, cleaned with gauze and washed with air-water spray. Two bleaching sessions were performed at a 1-week interval. Participants were advised to maintain regular oral hygiene by brushing with toothpaste that does not contain desensitizing or whitening ingredients.
HP18 is applied in 5 applications of 10 minutes per session. HP25 is applied in 3 applications of 15 minutes per session. HP40 is applied in 3 applications of 15 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| HP18 | Active comparator | Bleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite Receives: Other: Bleaching treatment |
| HP25 | Active comparator | Bleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite Receives: Other: Bleaching treatment |
| HP40 | Active comparator | Bleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite Receives: Other: Bleaching treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Shade evaluation
Tooth color was objectively evaluated using VitaTM Easy Shade V spectrophotometer (VITA Zanhnfabrik, BadSckingrn, Germany). The assesment was performed with daylight (10 a.m.to 2 p.m.) considering a 6 mm area situated in the middle section of the labial surface of the upper central incisors. In order to ensure consistency, alginate impressions were taken of the upper dental arches of each participant and stone molds were created. The custom trays were fabricated by using a 2mm Essix plate (Essix C; Dentsply, FL, USA) in a vacuum press machine (Ministar, Scheu, Iserlohn, Nordrhein-Westfalen Germany). 6 mm wide holes were drilled in the middle third of the buccal face of the central incisors on this trays to serve as a guide for using Easyshade V.
Measured: baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session
Secondary outcomes (1)
Tooth sensitivity evaluation
To measure tooth sensitivity, participants indicated their discomfort level using a Visual Analog Scale (VAS).23 This scale is represented by a horizontal line measuring 10 centimeters in length. The endpoint of the line labeled "no pain" represents the absence of discomfort, while the opposite endpoint labeled "worst pain" represents the highest level of discomfort.
Measured: baseline, immediately after the first bleaching session, two hours later, and 7 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start11 Sep 2023
- Primary completion15 Oct 2023
- Study completion15 Mar 2024
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- A 6-month a double-blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife ALTINIŞIK, Gazi University
- Investigators
- Associate Prof, Study director, Gazi UniversityResearch assistant, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700434
- Sponsor's protocol ID
- TGA-2023-8355
- Status last verified
- Mar 2024
- First submitted
- 15 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altinisik H, Nezir M. Clinical evaluation of in-office bleaching with low, medium, and high concentrate hydrogen peroxide: a 6-month a double-blinded randomized controlled trial. Clin Oral Investig. 2025 Apr 21;29(5):260. doi: 10.1007/s00784-025-06348-8.
PubMed 40259078
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06700434
- Acronym / sponsor ID
- TGA-2023-8355
- Conditions
- Tooth Discoloration
- Keywords
- Hydrogen Peroxide, In-office bleaching, Randomized clinical trial, Tooth sensitivity, Whitening effectiveness, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 22 Nov 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.
Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.
Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A 6-month a double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HP18 | Active comparator | Other: Bleaching treatmentBleaching agent containing Hydrogen Peroxide 18% and nano- hydroxyapatite |
| HP25 | Active comparator | Other: Bleaching treatmentBleaching agent containing Hydrogen Peroxide 20% and nano- hydroxyapatite |
| HP40 | Active comparator | Other: Bleaching treatmentBleaching agent containing Hydrogen Peroxide 40% and nano- hydroxyapatite |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women and men (at least 18 years old)
- People with good oral and general health
- People without periodontal disease
- Teeth without caries
- Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)
Key exclusion criteria (7 listed)
- Having undergone teeth bleaching procedure in the last 2 years,
- People with tooth sensitivity,
- Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
- People with gingival recession,
- Discoloration due to parafunction, tetracycline or fluorosis,
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 |
|---|---|---|
| Bleaching treatmentAfter the lip retractor (OptraGate, Ivoclar Vivadent, Schaan, Liechtenstein) was placed, the gingival barrier protection (Biowhiten, Biodent Ltd., İstanbul, Turkey) included in the products was applied to the upper and lower arches from premolar to premolar at the beginning of each session and removed after each treatment. The bleaching gels were applied according to the manufacturer and removed after the recommended period with a disposable surgical saliva ejector, cleaned with gauze and washed with air-water spray. Two bleaching sessions were performed at a 1-week interval. Participants were advised to maintain regular oral hygiene by brushing with toothpaste that does not contain desensitizing or whitening ingredients. HP18 is applied in 5 applications of 10 minutes per session. HP25 is applied in 3 applications of 15 minutes per session. HP40 is applied in 3 applications of 15 minutes per session. | Other | HP18, HP25, HP40 |
Primary outcome
Tooth Shade evaluation
Time frame: baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session
Tooth color was objectively evaluated using VitaTM Easy Shade V spectrophotometer (VITA Zanhnfabrik, BadSckingrn, Germany). The assesment was performed with daylight (10 a.m.to 2 p.m.) considering a 6 mm area situated in the middle section of the labial surface of the upper central incisors. In order to ensure consistency, alginate impressions were taken of the upper dental arches of each participant and stone molds were created. The custom trays were fabricated by using a 2mm Essix plate (Essix C; Dentsply, FL, USA) in a vacuum press machine (Ministar, Scheu, Iserlohn, Nordrhein-Westfalen Germany). 6 mm wide holes were drilled in the middle third of the buccal face of the central incisors on this trays to serve as a guide for using Easyshade V.
1 secondary outcome
Tooth sensitivity evaluation
Time frame: baseline, immediately after the first bleaching session, two hours later, and 7 days later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 40259078Altinisik H, Nezir M. Clinical evaluation of in-office bleaching with low, medium, and high concentrate hydrogen peroxide: a 6-month a double-blinded randomized controlled trial. Clin Oral Investig. 2025 Apr 21;29(5):260. doi: 10.1007/s00784-025-06348-8.
- 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.
Associate Prof study director
Gazi University
Research assistant principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleaching treatment in people with Tooth Discoloration, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 22 Nov 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth Shade evaluation (time frame: baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session). 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 NCT06700434, 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 22 Nov 2024.