Orthodontic Appliance ComplicationNCT05499923
Quantitative Measurement of ARI
A study testing Debonding in people with Orthodontic Appliance Complication, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial summary
A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Debonding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to 21 Jun 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All the patients undergoing comprehensive orthodontic treatment by fixed orthodontics
- No reporting of bracket failure in the last 6 months.
- Same company metal brackets used.
- Same adhesive used with same bonding protcol
Who cannot join
- Syndromic patient
- An episode of bracket failure in the last six months
- Short-term orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial
A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface.
The aim of this study is to do a randomized clinical trial to measure adhesive remanent index quantitively after debonding with wing and base method of debonding
Read the detailed description
After informed consent data would be collected from patients who are undergoing debonding of orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the cases which have no loose anterior upper and lower brackets for the last 6 months would be randomly allocated to one of the two sides in each arch for debonding with a specific technique. A protocol of block randomization would be followed for this study. Debonding of brackets would be done either by wing or base method in a split fashion after removal of orthodontic wires. The patient would be explained that both methods are conventional used and are safe for debonding. After debonding each bracket the patient would be asked for the level of pain he felt during the debonding of that specific bracket. The patient will explain the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain. After debonding a digital microscope (Supereyes) would be used along with plastic tubing for taking the adhesive remanent pictures intraorally from the labial surface of teeth. The plastic tubing would have a calibrated scale attached to it. For each new patient, a new tubing or disinfected tubing would be used. The available data would be measured extra orally on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of adhesive flush, and pain would be analyzed.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Debonding
- Keywords
- Bracket Debonding , Wing method, Base method , ARI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebondingDevice
Debonding of orthodontic brackets with wing or base method with a conventional debonding plier
| Study group | Role | What they receive |
|---|---|---|
| Wing method of debonding | Active comparator | In this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of wings and a squeezing force would be applied. Receives: Device: Debonding |
| Base method of debonding | Active comparator | In this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of the bracket base and a squeezing force would be applied. Receives: Device: Debonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesive remnant index
Quantitative Measurement of adhesive remnant index by a digital handheld microscope
Measured: 6 months
Secondary outcomes (1)
Patient reported outcome: Pain
After debonding each bracket patient will score the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain
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 posted12 Aug 2022
- Study start1 Oct 2021
- Primary completion1 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Split mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haris Khan, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499923
- Sponsor's protocol ID
- ERC/CMH/LMC/621
- Status last verified
- Aug 2022
- First submitted
- 21 Jun 2022
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05499923
- Acronym / sponsor ID
- ERC/CMH/LMC/621
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Bracket Debonding , Wing method, Base method , ARI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 12 Aug 2022 (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.
A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface.
The aim of this study is to do a randomized clinical trial to measure adhesive remanent index quantitively after debonding with wing and base method of debonding
Detailed description
After informed consent data would be collected from patients who are undergoing debonding of orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the cases which have no loose anterior upper and lower brackets for the last 6 months would be randomly allocated to one of the two sides in each arch for debonding with a specific technique. A protocol of block randomization would be followed for this study. Debonding of brackets would be done either by wing or base method in a split fashion after removal of orthodontic wires. The patient would be explained that both methods are conventional used and are safe for debonding. After debonding each bracket the patient would be asked for the level of pain he felt during the debonding of that specific bracket. The patient will explain the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain. After debonding a digital microscope (Supereyes) would be used along with plastic tubing for taking the adhesive remanent pictures intraorally from the labial surface of teeth. The plastic tubing would have a calibrated scale attached to it. For each new patient, a new tubing or disinfected tubing would be used. The available data would be measured extra orally on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of adhesive flush, and pain would be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Wing method of debonding | Active comparator | Device: DebondingIn this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of wings and a squeezing force would be applied. |
| Base method of debonding | Active comparator | Device: DebondingIn this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of the bracket base and a squeezing force would be applied. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All the patients undergoing comprehensive orthodontic treatment by fixed orthodontics
- No reporting of bracket failure in the last 6 months.
- Same company metal brackets used.
- Same adhesive used with same bonding protcol
Key exclusion criteria (3 listed)
- Syndromic patient
- An episode of bracket failure in the last six months
- Short-term orthodontic treatment
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 |
|---|---|---|
| DebondingDebonding of orthodontic brackets with wing or base method with a conventional debonding plier | Device | Base method of debonding, Wing method of debonding |
Primary outcome
Adhesive remnant index
Time frame: 6 months
Quantitative Measurement of adhesive remnant index by a digital handheld microscope
1 secondary outcome
Patient reported outcome: Pain
Time frame: 6 months
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 12 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debonding in people with Orthodontic Appliance Complication, run by CMH Lahore Medical College and Institute of Dentistry 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 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 12 Aug 2022. 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?
Adhesive remnant index (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 12 Aug 2022.