Enamel DemineralizationNCT07752290
Comparative Assessment of Adhesive PreCoated (APC) Flash-free and Conventional Brackets and the Effects on Enamel Demineralization and Periodontal Health
A study testing Group A and Group B in people with Enamel Demineralization, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Adhesive PreCoated (APC) flash-free brackets have been recently introduced, with no need of flash removal step. Evaluation of APC and conventional brackets and their effects on enamel demineralization and periodontal health. Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Demineralization
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2024to 10 Dec 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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Good periodontal health with no history of systemic problems
- Mild to moderate crowding
- Class I and Class II malocclusions
- Non extraction treatment plan
- Permanent dentition and no visible demineralization of buccal/labial surfaces of teeth
- Absence of rotated teeth
- No past history of orthodontic treatment
Who cannot join
- Severe Class III/Class II malocclusions
- Primary/mixed dentition
- Patients not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Assessment of Adhesive PreCoated (APC) Flash-free and Conventional Brackets, and the Effects on Enamel Demineralization and Periodontal Health
Adhesive PreCoated (APC) flash-free brackets have been recently introduced, with no need of flash removal step. Evaluation of APC and conventional brackets and their effects on enamel demineralization and periodontal health.
Read the detailed description
Comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets, and their effects on enamel demineralization and periodontal health.
- Conditions
- Enamel Demineralization
- Being tested
- Group A, Group B
- Keywords
- Periodontal Index, Bleeding on probing, Laser fluorescence, Oral Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Adhesive PreCoated (APC) Flash-free brackets
Group BOther
Conventional brackets (Ortho Care UK Ltd)
| Study group | Role | What they receive |
|---|---|---|
| APC brackets (3M Oral Care St.Paul, MN, USA) | Experimental | PreCoated brackets (APC) Receives: Other: Group A |
| Conventional Brackets (UK Ltd) | Active comparator | Non-coated brackets Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets and their effects on enamel demineralization and periodontal health
To evaluate the difference of APC and conventional brackets, and their effects on enamel demineralization and periodontal health using diagnodont pen using numerical value on a 0 to 99 scale. 0 - 12: Healthy tooth structure; no or minimal fluorescence.13 - 24: Enamel caries, 25 - 99: Dentin caries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start20 Jul 2024
- Primary completion10 Nov 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel DemineralizationStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
- Investigators
- Shoaib Rahim, FCPS, Study director, FUCD & H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752290
- Sponsor's protocol ID
- FUCDCLINIC-2405
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: University policy to maintain patients confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Assessment of Adhesive PreCoated (APC) Flash-free and Conventional Brackets, and the Effects on Enamel Demineralization and Periodontal Health
- ClinicalTrials.gov ID
- NCT07752290
- Acronym / sponsor ID
- FUCDCLINIC-2405
- Conditions
- Enamel Demineralization
- Keywords
- Periodontal Index, Bleeding on probing, Laser fluorescence, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 7 Aug 2026 (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.
Adhesive PreCoated (APC) flash-free brackets have been recently introduced, with no need of flash removal step. Evaluation of APC and conventional brackets and their effects on enamel demineralization and periodontal health.
Detailed description
Comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets, and their effects on enamel demineralization and periodontal health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APC brackets (3M Oral Care St.Paul, MN, USA) | Experimental | Other: Group APreCoated brackets (APC) |
| Conventional Brackets (UK Ltd) | Active comparator | Other: Group BNon-coated brackets |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Good periodontal health with no history of systemic problems
- Mild to moderate crowding
- Class I and Class II malocclusions
- Non extraction treatment plan
- Permanent dentition and no visible demineralization of buccal/labial surfaces of teeth
Key exclusion criteria (3 listed)
- Severe Class III/Class II malocclusions
- Primary/mixed dentition
- Patients not willing to participate in the study
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 |
|---|---|---|
| Group AAdhesive PreCoated (APC) Flash-free brackets | Other | APC brackets (3M Oral Care St.Paul, MN, USA) |
| Group BConventional brackets (Ortho Care UK Ltd) | Other | Conventional Brackets (UK Ltd) |
Primary outcome
comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets and their effects on enamel demineralization and periodontal health
Time frame: 6 months
To evaluate the difference of APC and conventional brackets, and their effects on enamel demineralization and periodontal health using diagnodont pen using numerical value on a 0 to 99 scale. 0 - 12: Healthy tooth structure; no or minimal fluorescence.13 - 24: Enamel caries, 25 - 99: Dentin caries
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 13 Aug 2026.
- Individual participant dataSharing planned: No. University policy to maintain patients confidentiality
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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.
Shoaib Rahim, FCPS study director
FUCD & H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Enamel Demineralization, run by Foundation University Islamabad at 1 site in Pakistan.
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 3 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 13 Aug 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 Pakistan. 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?
comparative assessment of Adhesive PreCoated (APC) flash-free and conventional brackets and their effects on enamel demineralization and periodontal health (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.