White Spot LesionsNCT07291830
A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
A study testing Remineralizing self-etch primer (M-SEP, SEP 1) and Standard self-etch primer (P-SEP, SEP 2) in people with White Spot Lesions and Enamel Demineralization, run by University of Baghdad at 1 site in Iraq.
Trial summary
This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the… Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions, Enamel Demineralization
- What is being tested?
- Remineralizing self-etch primer (M-SEP, SEP 1) and Standard self-etch primer (P-SEP, SEP 2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 15 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;
- Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,
- No previous orthodontic treatment with fixed appliances.
Who cannot join
- Participants unable to give informed consent,
- Had craniofacial anomalies,
- Require orthognathic surgery as part of their treatment,
- Had congenital enamel defects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali I Ibrahim, Professor contact
Iraq1 site
College of Dentistry, University of Baghdad - Orthodontic Dept/Postgraduate Clinic
Baghdad, Baghdad Governorate, 1417
Diyar Taher Agha, MSc Candidate, 009647705880686, aghadiyar169@gmail.com
Ali I Ibrahim, Professor
About this study
Official title: Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Read the detailed description
To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Objectives:
Primary; Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
Secondary;
- Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.
- Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.
- Measuring the total time required for remnant adhesive removal post bracket failure/debonding.
- Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.
- Conditions
- White Spot Lesions, Enamel Demineralization
- Being tested
- Remineralizing self-etch primer (M-SEP, SEP 1), Standard self-etch primer (P-SEP, SEP 2)
- Keywords
- Orthodontic Bracket Bonding, Self-Etch Primers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remineralizing self-etch primer (M-SEP, SEP 1)Device
Experimental self-etch primer based on Transbond Plus modified with 7% nano-hydroxyapatite. Applied to labial/buccal enamel of incisors, canines, and premolars after pumice prophylaxis; air-dried 3 s, brackets bonded with Transbond XT and LED light-cured 10 s mesial and 10 s distal.
Standard self-etch primer (P-SEP, SEP 2)Device
Conventional Transbond Plus self-etch primer used according to manufacturer's instructions for enamel conditioning of incisors, canines, and premolars, followed by Transbond XT adhesive and LED light-curing as above.
| Study group | Role | What they receive |
|---|---|---|
| Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR | Experimental | Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches. Receives: Device: Remineralizing self-etch primer (M-SEP, SEP 1); Device: Standard self-etch primer (P-SEP, SEP 2) |
| Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL | Experimental | Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A. Receives: Device: Remineralizing self-etch primer (M-SEP, SEP 1); Device: Standard self-etch primer (P-SEP, SEP 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket Bond Failure Rate
Documented as a percentage of brackets debonded during the 6-month observation period, categorized by location (incisor, canine, premolar) and cause (adhesive failure, cohesive failure, bracket fracture .
Measured: 6 MONTH
Secondary outcomes (1)
Adhesive Remnant Index
Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionsStudies 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
- Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali I Ibrahim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291830
- Sponsor's protocol ID
- 1102425
- Status last verified
- May 2026
- First submitted
- 5 Dec 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing is planned because patient consent and institutional policy do not allow external sharing of individual-level data."
Publications
Erbe C, Hartmann L, Schmidtmann I, Ohlendorf D, Wehrbein H. A novel method quantifying caries following orthodontic treatment. Sci Rep. 2021 Nov 1;11(1):21347. doi: 10.1038/s41598-021-00561-7.
PubMed 34725354Garma NMH, Ibrahim AI. Development of a remineralizing calcium phosphate nanoparticle-containing self-etching system for orthodontic bonding. Clin Oral Investig. 2023 Apr;27(4):1483-1497. doi: 10.1007/s00784-022-04767-5. Epub 2022 Nov 2.
PubMed 36322155
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07291830
- Acronym / sponsor ID
- 1102425
- Conditions
- White Spot Lesions, Enamel Demineralization
- Keywords
- Orthodontic Bracket Bonding, Self-Etch Primers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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 randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Detailed description
To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Objectives:
Primary; Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
Secondary;
- Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.
- Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.
- Measuring the total time required for remnant adhesive removal post bracket failure/debonding.
- Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR | Experimental | Device: Remineralizing self-etch primer (M-SEP, SEP 1), Device: Standard self-etch primer (P-SEP, SEP 2)Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches. |
| Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL | Experimental | Device: Remineralizing self-etch primer (M-SEP, SEP 1), Device: Standard self-etch primer (P-SEP, SEP 2)Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;
- Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,
- No previous orthodontic treatment with fixed appliances.
Key exclusion criteria (4 listed)
- Participants unable to give informed consent,
- Had craniofacial anomalies,
- Require orthognathic surgery as part of their treatment,
- Had congenital enamel defects.
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 |
|---|---|---|
| Remineralizing self-etch primer (M-SEP, SEP 1)Experimental self-etch primer based on Transbond Plus modified with 7% nano-hydroxyapatite. Applied to labial/buccal enamel of incisors, canines, and premolars after pumice prophylaxis; air-dried 3 s, brackets bonded with Transbond XT and LED light-cured 10 s mesial and 10 s distal. | Device | Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL, Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR |
| Standard self-etch primer (P-SEP, SEP 2)Conventional Transbond Plus self-etch primer used according to manufacturer's instructions for enamel conditioning of incisors, canines, and premolars, followed by Transbond XT adhesive and LED light-curing as above. | Device | Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL, Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR |
Primary outcome
Bracket Bond Failure Rate
Time frame: 6 MONTH
Documented as a percentage of brackets debonded during the 6-month observation period, categorized by location (incisor, canine, premolar) and cause (adhesive failure, cohesive failure, bracket fracture .
1 secondary outcome
Adhesive Remnant Index
Time frame: 6 MONTH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 34725354Erbe C, Hartmann L, Schmidtmann I, Ohlendorf D, Wehrbein H. A novel method quantifying caries following orthodontic treatment. Sci Rep. 2021 Nov 1;11(1):21347. doi: 10.1038/s41598-021-00561-7.
- Background: PubMed 36322155Garma NMH, Ibrahim AI. Development of a remineralizing calcium phosphate nanoparticle-containing self-etching system for orthodontic bonding. Clin Oral Investig. 2023 Apr;27(4):1483-1497. doi: 10.1007/s00784-022-04767-5. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No. No IPD sharing is planned because patient consent and institutional policy do not allow external sharing of individual-level data."
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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.
Ali I Ibrahim, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remineralizing self-etch primer (M-SEP, SEP 1) and Standard self-etch primer (P-SEP, SEP 2) in people with White Spot Lesions and Enamel Demineralization, run by University of Baghdad at 1 site in Iraq.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 May 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DIYAR TAHER AGHA, MSc Candidate (009647705880686, aghadiyar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bracket Bond Failure Rate (time frame: 6 MONTH). 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 NCT07291830, which also lists 2 linked publications.
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 7 May 2026.