Tooth BleachingNCT04855279
Prevention of Bleaching Induced Sensitivity
A study testing neutral sodium fluoride, ACP-CCP gel and nano-hydroxyapatite solution in people with Tooth Bleaching and Tooth Sensitivity, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the use of different desensitizing agents before in-office bleaching. A total of 64 volunteers were randomly divided into four groups. Before undergoing in-office bleaching with 38% hydrogen peroxide gel (three applications of 15 minutes each, one session), clinicians applied a placebo gel… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching, Tooth Sensitivity
- What is being tested?
- neutral sodium fluoride, ACP-CCP gel and nano-hydroxyapatite solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2019to 26 Jul 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have all their upper and lower anterior teeth
- Must have good oral hygiene
Who cannot join
- Pregnancy or breastfeeding
- Systemic disease
- Taking NSAIDs or other drug treatment.
- Periodontal disease
- Enamel hypoplasia
- Teeth stained by tetracycline or fluorosis
Show all 12Show fewer
- Dental malposition or orthodontic treatment with fixed appliances
- Canine teeth lighter than A1
- Restoration on anterior teeth
- Cervical lesions
- Symptoms of dental pain
- Previous tooth whitening experience.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
This study aims to evaluate the use of different desensitizing agents before in-office bleaching. A total of 64 volunteers were randomly divided into four groups. Before undergoing in-office bleaching with 38% hydrogen peroxide gel (three applications of 15 minutes each, one session), clinicians applied a placebo gel (control group), casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), neutral sodium fluoride gel (NSF), or nano-hydroxyapatite solution (n-HAP) on all buccal surfaces of teeth. The gel was left undisturbed for 4 minutes. Patients recorded their tooth sensitivities on the VAS scale. Kruskal-Wallis test followed by Mann-Whitney U test were used to compare changes in tooth color and intensity of tooth sensitivity between groups.
Read the detailed description
Color evaluation was performed with Vita Shade Guide Classical (Vitapan Classical, Vita, Bad Sakingen, Germany). The shades were evaluated with shade guide units (SGUs). Vita Classical Shade Guide consisted of 16 shades, and the shades were aligned light-to-dark from B1-C4.21, 22 The shades were taken before and after 24 hours and 7 days of treatment.Next, the hypersensitivity was recorded by asking each subject to establish his or her perception of sensitivity before treatment using a visual analog scale (VAS). A stimulus of an evaporative blowing triple syringe (25 psi at ambient conditions) was applied for 3 seconds on the upper central incisors from a distance of 1 cm. After 24 hours and 7 days of bleaching treatment, stimuli testing was performed again.The subjects were divided into four groups. Group 1. Subjects were treated with a placebo gel. The agent was applied for 4 min. to all the teeth to be bleached. Group 2. Subjects were treated with ACP-CCP gel (Tooth Mousse, GC Corp., Tokyo, Japan) for 4 min. to all the teeth to be bleached. Group 3. Subjects were treated with nano-hydroxyapatite solution for 4 min. to all the teeth to be bleached. Group 4. Subjects were treated with neutral sodium fluoride (NSF) gel for 4 min. to all the teeth to be bleached. After treatment, the agent was removed by washing with water in all groups. Each subject underwent one session of bleaching on the anterior teeth from canine-to-canine. Bleaching systems were applied according to the manufacturer's instructions by one of the authors. Subjects were treated with hydrogen peroxide at 38% activated by a light source composed of 12 LEDs with blue light generators. The calculated hypersensitivity values and color change values were tested with Shapiro-Wilk and Levene tests for normal data distribution and homogeneity of variances. Kruskal-Wallis test followed by Mann-Whitney U test was performed to compare groups.
- Conditions
- Tooth Bleaching, Tooth Sensitivity
- Being tested
- neutral sodium fluoride, ACP-CCP gel, nano-hydroxyapatite solution, glycerine
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neutral sodium fluorideOther
Topically applied
ACP-CCP gelOther
Topically applied
nano-hydroxyapatite solutionOther
Topically applied
glycerineOther
Topically applied
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: glycerine |
| Topical neutral sodium fluoride | Active comparator | Not described Receives: Other: neutral sodium fluoride |
| ACP-CCP gel | Active comparator | Not described Receives: Other: ACP-CCP gel |
| nano-hydroxyapatite solution | Active comparator | Not described Receives: Other: nano-hydroxyapatite solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of reducing hypersensitivity after bleaching
VAS scale (Visual Analog Scale) was measured before and after bleaching
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start7 Jan 2019
- Primary completion28 Jun 2019
- Study completion26 Jul 2019
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 BleachingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benin Dikmen, Medipol University
- Investigators
- Benin Dikmen, Dr., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855279
- Sponsor's protocol ID
- KN453
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
PubMed 21488723
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
- ClinicalTrials.gov ID
- NCT04855279
- Acronym / sponsor ID
- KN453
- Conditions
- Tooth Bleaching, Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 22 Apr 2021 (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.
This study aims to evaluate the use of different desensitizing agents before in-office bleaching. A total of 64 volunteers were randomly divided into four groups. Before undergoing in-office bleaching with 38% hydrogen peroxide gel (three applications of 15 minutes each, one session), clinicians applied a placebo gel (control group), casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), neutral sodium fluoride gel (NSF), or nano-hydroxyapatite solution (n-HAP) on all buccal surfaces of teeth. The gel was left undisturbed for 4 minutes. Patients recorded their tooth sensitivities on the VAS scale. Kruskal-Wallis test followed by Mann-Whitney U test were used to compare changes in tooth color and intensity of tooth sensitivity between groups.
Detailed description
Color evaluation was performed with Vita Shade Guide Classical (Vitapan Classical, Vita, Bad Sakingen, Germany). The shades were evaluated with shade guide units (SGUs). Vita Classical Shade Guide consisted of 16 shades, and the shades were aligned light-to-dark from B1-C4.21, 22 The shades were taken before and after 24 hours and 7 days of treatment.Next, the hypersensitivity was recorded by asking each subject to establish his or her perception of sensitivity before treatment using a visual analog scale (VAS). A stimulus of an evaporative blowing triple syringe (25 psi at ambient conditions) was applied for 3 seconds on the upper central incisors from a distance of 1 cm. After 24 hours and 7 days of bleaching treatment, stimuli testing was performed again.The subjects were divided into four groups. Group 1. Subjects were treated with a placebo gel. The agent was applied for 4 min. to all the teeth to be bleached. Group 2. Subjects were treated with ACP-CCP gel (Tooth Mousse, GC Corp., Tokyo, Japan) for 4 min. to all the teeth to be bleached. Group 3. Subjects were treated with nano-hydroxyapatite solution for 4 min. to all the teeth to be bleached. Group 4. Subjects were treated with neutral sodium fluoride (NSF) gel for 4 min. to all the teeth to be bleached. After treatment, the agent was removed by washing with water in all groups. Each subject underwent one session of bleaching on the anterior teeth from canine-to-canine. Bleaching systems were applied according to the manufacturer's instructions by one of the authors. Subjects were treated with hydrogen peroxide at 38% activated by a light source composed of 12 LEDs with blue light generators. The calculated hypersensitivity values and color change values were tested with Shapiro-Wilk and Levene tests for normal data distribution and homogeneity of variances. Kruskal-Wallis test followed by Mann-Whitney U test was performed to compare groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: glycerine |
| Topical neutral sodium fluoride | Active comparator | Other: neutral sodium fluoride |
| ACP-CCP gel | Active comparator | Other: ACP-CCP gel |
| nano-hydroxyapatite solution | Active comparator | Other: nano-hydroxyapatite solution |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must have all their upper and lower anterior teeth
- Must have good oral hygiene
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding
- Systemic disease
- Taking NSAIDs or other drug treatment.
- Periodontal disease
- Enamel hypoplasia
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 |
|---|---|---|
| neutral sodium fluorideTopically applied | Other | Topical neutral sodium fluoride |
| ACP-CCP gelTopically applied | Other | ACP-CCP gel |
| nano-hydroxyapatite solutionTopically applied | Other | nano-hydroxyapatite solution |
| glycerineTopically applied | Other | Control |
Primary outcome
Effect of reducing hypersensitivity after bleaching
Time frame: 1 week
VAS scale (Visual Analog Scale) was measured before and after bleaching
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 28 Apr 2021.
- Background: PubMed 21488723Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
- 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.
Benin Dikmen, Dr. principal investigator
Medipol 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 neutral sodium fluoride, ACP-CCP gel and nano-hydroxyapatite solution in people with Tooth Bleaching and Tooth Sensitivity, run by Medipol 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 2 inclusion and 12 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 28 Apr 2021. 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. 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?
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?
Effect of reducing hypersensitivity after bleaching (time frame: 1 week). 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 NCT04855279, 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 28 Apr 2021.