Survival Rate of Bonded BracketsEarly Phase 1NCT07155343
Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment
A Early Phase 1 study testing Bulk Fill Composite and Conventional Composite in people with Survival Rate of Bonded Brackets, run by Rizwan Khalil at 1 site in Pakistan.
Trial summary
The primary objective of this study is to compare the survival rate (days) of orthodontic bracket bond to the tooth, and the secondary objective is to compare the dental plaque accumulation and gingival health using plaque index and gingival index respectively between brackets bonded with bulk fill composite and light… Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Survival Rate of Bonded Brackets
- What is being tested?
- Bulk Fill Composite and Conventional Composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Jul 2025to 31 Dec 2025
- Phase
- Early Phase 1
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Patients aged between 13 - 40 years
- Patients undergoing fixed orthodontic treatment
- Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
- All patients who will sign the informed consent/assent form
Who cannot join
- • Patients with enamel surface defects
- Patients with any periodontal disease i.e. gingivitis or periodontitis
- Patients with any systemic diseases i.e. diabetes and hypertension
- Pregnant or nursing females
- Patients with craniofacial syndromes
- Subjects with a previous history of orthodontic or orthopedic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74800
Rizwan Khalil, BDS, +923326078008, rizwan.khalil@aku.edu
Rizwan Khalil, Bachelor of Dental Surgery
About this study
Official title: Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment - A Split-mouth Randomized Controlled Trial
The primary objective of this study is to compare the survival rate (days) of orthodontic bracket bond to the tooth, and the secondary objective is to compare the dental plaque accumulation and gingival health using plaque index and gingival index respectively between brackets bonded with bulk fill composite and light cure conventional composite in patients undergoing fixed orthodontic treatment over a period of three months.
Read the detailed description
After obtaining approval from the Ethical Review Committee and taking informed assent and informed consent from the child and parents respectively, patients fulfilling the study selection criteria will be recruited in the study as participants. Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study. Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study. Bulk fill composite and light cure conventional composite will be used to bond the brackets in the study participants undergoing orthodontic treatment. Bulk fill composite and light cure conventional composite will be randomly allocated to the right and left quadrants of maxillary and mandibular arches. Bracket bond failure and clinical measurements (plaque accumulation and gingival health) will be recorded at four intervals. First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3). Data will be collected on an organized study proforma.
Interim analysis will be run to ensure that there are no unexpected safety concerns associated with the intervention. The analysis may help determine whether the intervention is effective in achieving its desired outcomes or if there are indications of potential success. If the interim analysis will reveal overwhelming evidence of effectiveness or futility, the trial will be terminated early, saving time, money, and potential exposure to participants.
Intention to treat analysis will be applied to maintain the benefits of randomization and avoid introducing bias due to non-adherence or dropouts. By analyzing participants as part of their original assigned group, the ITT analysis provides a more conservative estimate of treatment effects, reflecting real-world scenarios where not everyone perfectly adheres to the assigned treatment.
Randomization:
Block randomization will be used to determine which side of teeth (right or left side quadrants) the bulk-fill composite will be used to bond the brackets in each participant. This will be controlled by a research faculty member of the Section of Dentistry assigned to the research by the Clinical Trials Unit AKUH.
Random Sequence Generation:
In this two-armed study, fifteen blocks each with a block size of four with any of the following six-possible allocation sequences for two treatment arms will be generated.
(1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA, (6) BAAB The blocks to be utilized and their order will be determined by the research Faculty member using sealed envelopeTM online software.
Allocation Sequence Concealment:
The treatment allocation pattern determined against each participant's ID (01-58, in ascending order) by the research faculty member, will be printed individually on paper. These papers will be sealed in an opaque envelope with the participants' ID mentioned over the envelope by a team member independent of the trial.
Enrollment:
After obtaining approval from the ERC (AKUH), each participant fulfilling the inclusion criteria for the study and consenting to participate in the trial will be assigned a participant ID.
Implementation:
During the recruitment of the participants in the trial, the sealed envelope for a participant ID will be opened to reveal the random sequence by the enrolling team member.
Blinding:
The study investigators, patients and assessors will not be blinded during the trial. The patients will be recruited by the co-principal investigator. All the measurements will be recorded by the co-investigator on the study proforma.
Inclusion Criteria:
- Patients aged between 12 - 40 years
- Patients undergoing fixed orthodontic treatment
- Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
- All patients who will sign the informed consent/assent form
Exclusion Criteria:
- Patients with enamel surface defects
- Patients with any periodontal disease i.e. gingivitis or periodontitis
- Patients with any systemic diseases i.e. diabetes and hypertension
- Pregnant or nursing females
- Patients with craniofacial syndromes
- Subjects with a previous history of orthodontic or orthopedic treatment
- Conditions
- Survival Rate of Bonded Brackets
- Being tested
- Bulk Fill Composite, Conventional Composite
- Keywords
- Bulk fill composite, Bond failure rate, Fixed orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk Fill CompositeCombination product
Orthodontic brackets will be bonded using a bulk fill composite resin, which is formulated for faster application and reduced polymerization shrinkage compared to conventional composites. This material will be used to assess its bond strength, failure rate, and overall clinical performance.
Conventional CompositeCombination product
Orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin that requires careful incremental application and standard curing time. This material is commonly used in routine clinical practice and serves as the benchmark for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Brackets Bonded Using Bulk Fill Composite | Experimental | In this arm, orthodontic brackets will be bonded using a light-cured bulk fill composite resin material. The composite will be applied directly to the bracket base and cured according to the manufacturer's instructions. This group is intended to evaluate the clinical performance, bond failure rate, and handling characteristics of bulk fill composite in comparison to conventional orthodontic bonding resin. Brackets will be placed on either the right or left side of the arch, based on random allocation. Receives: Combination Product: Bulk Fill Composite |
| Brackets Bonded Using Conventional Composite | Active comparator | In this arm, orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin. The composite will be applied to the bracket base and cured according to the manufacturer's recommended protocol. This group will serve as the control to compare the bond strength, failure rate, and clinical performance against the bulk fill composite group. Brackets will be placed on either the right or left side of the arch, depending on the random allocation. Receives: Combination Product: Conventional Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Time of Orthodontic Bracket Bond
The number of days the bonded orthodontic brackets remain adhered to the tooth surface without failure. Bracket bond failure will be recorded at each follow-up visit, and survival time will be calculated for each bracket in both intervention groups (bulk fill composite vs conventional composite). The aim is to compare the average survival duration between the two materials over the study period.
Measured: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).
Secondary outcomes (1)
Plaque Accumulation and Gingival Health
Dental plaque accumulation and gingival health will be assessed using the Plaque Index and Gingival Index, respectively. These clinical indices will be measured around brackets bonded with bulk fill composite and conventional composite. The comparison will help evaluate whether the type of bonding material influences oral hygiene status and gingival inflammation during fixed orthodontic treatment.
Measured: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start21 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival Rate of Bonded BracketsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rizwan Khalil
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University Hospital, Pakistan
- Responsible party
- Sponsor-investigator, Rizwan Khalil, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155343
- Sponsor's protocol ID
- 2024-9142-30284
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment - A Split-mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07155343
- Acronym / sponsor ID
- 2024-9142-30284
- Conditions
- Survival Rate of Bonded Brackets
- Keywords
- Bulk fill composite, Bond failure rate, Fixed orthodontic treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Rizwan KhalilUniversity, hospital or other
- Collaborators
- Aga Khan University Hospital, Pakistan
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Sep 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.
The primary objective of this study is to compare the survival rate (days) of orthodontic bracket bond to the tooth, and the secondary objective is to compare the dental plaque accumulation and gingival health using plaque index and gingival index respectively between brackets bonded with bulk fill composite and light cure conventional composite in patients undergoing fixed orthodontic treatment over a period of three months.
Detailed description
After obtaining approval from the Ethical Review Committee and taking informed assent and informed consent from the child and parents respectively, patients fulfilling the study selection criteria will be recruited in the study as participants. Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study. Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study. Bulk fill composite and light cure conventional composite will be used to bond the brackets in the study participants undergoing orthodontic treatment. Bulk fill composite and light cure conventional composite will be randomly allocated to the right and left quadrants of maxillary and mandibular arches. Bracket bond failure and clinical measurements (plaque accumulation and gingival health) will be recorded at four intervals. First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3). Data will be collected on an organized study proforma.
Interim analysis will be run to ensure that there are no unexpected safety concerns associated with the intervention. The analysis may help determine whether the intervention is effective in achieving its desired outcomes or if there are indications of potential success. If the interim analysis will reveal overwhelming evidence of effectiveness or futility, the trial will be terminated early, saving time, money, and potential exposure to participants.
Intention to treat analysis will be applied to maintain the benefits of randomization and avoid introducing bias due to non-adherence or dropouts. By analyzing participants as part of their original assigned group, the ITT analysis provides a more conservative estimate of treatment effects, reflecting real-world scenarios where not everyone perfectly adheres to the assigned treatment.
Randomization:
Block randomization will be used to determine which side of teeth (right or left side quadrants) the bulk-fill composite will be used to bond the brackets in each participant. This will be controlled by a research faculty member of the Section of Dentistry assigned to the research by the Clinical Trials Unit AKUH.
Random Sequence Generation:
In this two-armed study, fifteen blocks each with a block size of four with any of the following six-possible allocation sequences for two treatment arms will be generated.
(1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA, (6) BAAB The blocks to be utilized and their order will be determined by the research Faculty member using sealed envelopeTM online software.
Allocation Sequence Concealment:
The treatment allocation pattern determined against each participant's ID (01-58, in ascending order) by the research faculty member, will be printed individually on paper. These papers will be sealed in an opaque envelope with the participants' ID mentioned over the envelope by a team member independent of the trial.
Enrollment:
After obtaining approval from the ERC (AKUH), each participant fulfilling the inclusion criteria for the study and consenting to participate in the trial will be assigned a participant ID.
Implementation:
During the recruitment of the participants in the trial, the sealed envelope for a participant ID will be opened to reveal the random sequence by the enrolling team member.
Blinding:
The study investigators, patients and assessors will not be blinded during the trial. The patients will be recruited by the co-principal investigator. All the measurements will be recorded by the co-investigator on the study proforma.
Inclusion Criteria:
- Patients aged between 12 - 40 years
- Patients undergoing fixed orthodontic treatment
- Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
- All patients who will sign the informed consent/assent form
Exclusion Criteria:
- Patients with enamel surface defects
- Patients with any periodontal disease i.e. gingivitis or periodontitis
- Patients with any systemic diseases i.e. diabetes and hypertension
- Pregnant or nursing females
- Patients with craniofacial syndromes
- Subjects with a previous history of orthodontic or orthopedic treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brackets Bonded Using Bulk Fill Composite | Experimental | Combination Product: Bulk Fill CompositeIn this arm, orthodontic brackets will be bonded using a light-cured bulk fill composite resin material. The composite will be applied directly to the bracket base and cured according to the manufacturer's instructions. This group is intended to evaluate the clinical performance, bond failure rate, and handling characteristics of bulk fill composite in comparison to conventional orthodontic bonding resin. Brackets will be placed on either the right or left side of the arch, based on random allocation. |
| Brackets Bonded Using Conventional Composite | Active comparator | Combination Product: Conventional CompositeIn this arm, orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin. The composite will be applied to the bracket base and cured according to the manufacturer's recommended protocol. This group will serve as the control to compare the bond strength, failure rate, and clinical performance against the bulk fill composite group. Brackets will be placed on either the right or left side of the arch, depending on the random allocation. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Patients aged between 13 - 40 years
Key exclusion criteria (6 listed)
- • Patients with enamel surface 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 |
|---|---|---|
| Bulk Fill CompositeOrthodontic brackets will be bonded using a bulk fill composite resin, which is formulated for faster application and reduced polymerization shrinkage compared to conventional composites. This material will be used to assess its bond strength, failure rate, and overall clinical performance. | Combination product | Brackets Bonded Using Bulk Fill Composite |
| Conventional CompositeOrthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin that requires careful incremental application and standard curing time. This material is commonly used in routine clinical practice and serves as the benchmark for comparison. | Combination product | Brackets Bonded Using Conventional Composite |
Primary outcome
Survival Time of Orthodontic Bracket Bond
Time frame: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).
The number of days the bonded orthodontic brackets remain adhered to the tooth surface without failure. Bracket bond failure will be recorded at each follow-up visit, and survival time will be calculated for each bracket in both intervention groups (bulk fill composite vs conventional composite). The aim is to compare the average survival duration between the two materials over the study period.
1 secondary outcome
Plaque Accumulation and Gingival Health
Time frame: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).
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 4 Sep 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bulk Fill Composite and Conventional Composite in people with Survival Rate of Bonded Brackets, run by Rizwan Khalil 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rizwan Khalil, Bachelor of Dental Surgery (+923326078008, rizwan.khalil@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Time of Orthodontic Bracket Bond (time frame: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).). 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 4 Sep 2025.