AnalgesiaNCT05104190
Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets
A study testing Stabilization of teeth during debonding using fingure pressure and elastic wafer in people with Analgesia and Orthodontic Appliance Complication, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
Purpose of this study was to evaluate different methods of controlling pain during debonding Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Orthodontic Appliance Complication
- What is being tested?
- Stabilization of teeth during debonding using fingure pressure and elastic wafer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 24 Jun 2020
- 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 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between 13-21 years of age who can understand, assess, and answer the questionnaires. 2) No missing teeth except extracted premolars 3) Undergoing upper and lower fixed orthodontic treatment with Roth prescription 0.022-inch metal brackets . 4) Finishing arch wires present for at least two months
Who cannot join
- The subjects with a previous history of facial or mandibular surgery or syndromes affecting the jaw or face .
- Patient with history of jaw sugeries.
- Patients with history of taking medicine periodically or in the last 24 hours (eg, painkillers, corticosteroids, and antiflu drugs),
- Patient with history of debonded brackets and replacement.
- Patient with history of tooth transplantation or microscrews placement.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of this study was to evaluate different methods of controlling pain during debonding
Read the detailed description
Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were divided into two groups, 55 patients in each group, based on method of controlling pain during debonding. To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.
- Conditions
- Analgesia, Orthodontic Appliance Complication
- Being tested
- Stabilization of teeth during debonding using fingure pressure and elastic wafer
- Keywords
- Orthodontic pain
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization of teeth during debonding using fingure pressure and elastic waferOther
To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.
| Study group | Role | What they receive |
|---|---|---|
| plastic wafers group | Experimental | In one arm/ group 1 (plastic wafers group), debonding was done by open mouth technique. All brackets were removed using same plier i.e. angled direct bracket remover. Figure pressure in the apical direction was applied concomitantly applied to stabilize each tooth. Loose cotton was used between thumb and tooth during debonding. Arch wires and ligatures were not removed during debonding.
Patient pain score during procedure was measured using visual analogue scale ranging from zero to one hundred (0-100) In Receives: Other: Stabilization of teeth during debonding using fingure pressure and elastic wafer |
| finger pressure group | Experimental | In another arm/ group 2( finger pressure group) brackets were removed in the same way with the same debonding plier as in group 1 but soft acrylic sheets folded 4 times were placed between upper and lower dentition with the patient biting on this wafer. Wires and ligatures were left tied to brackets during debonding. After the procedure, patient was asked about pain using visual analogue scale. Receives: Other: Stabilization of teeth during debonding using fingure pressure and elastic wafer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain
Using visual analogue scale pain was measured
Measured: Immediatey after debonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jan 2019
- Primary completion27 Jun 2019
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kashif Iqbal, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Zahra Khalid, BDS, FCPSII, Study chair, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104190
- Sponsor's protocol ID
- Orthodontic pain
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2021
- Last updated
- 2 Nov 2021
- 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 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets
- ClinicalTrials.gov ID
- NCT05104190
- Acronym / sponsor ID
- Orthodontic pain
- Conditions
- Analgesia, Orthodontic Appliance Complication
- Keywords
- Orthodontic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 2 Nov 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.
Purpose of this study was to evaluate different methods of controlling pain during debonding
Detailed description
Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were divided into two groups, 55 patients in each group, based on method of controlling pain during debonding. To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plastic wafers group | Experimental | Other: Stabilization of teeth during debonding using fingure pressure and elastic waferIn one arm/ group 1 (plastic wafers group), debonding was done by open mouth technique. All brackets were removed using same plier i.e. angled direct bracket remover. Figure pressure in the apical direction was applied concomitantly applied to stabilize each tooth. Loose cotton was used between thumb and tooth during debonding. Arch wires and ligatures were not removed during debonding. Patient pain score during procedure was measured using visual analogue scale ranging from zero to one hundred (0-100) In |
| finger pressure group | Experimental | Other: Stabilization of teeth during debonding using fingure pressure and elastic waferIn another arm/ group 2( finger pressure group) brackets were removed in the same way with the same debonding plier as in group 1 but soft acrylic sheets folded 4 times were placed between upper and lower dentition with the patient biting on this wafer. Wires and ligatures were left tied to brackets during debonding. After the procedure, patient was asked about pain using visual analogue scale. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients between 13-21 years of age who can understand, assess, and answer the questionnaires. 2) No missing teeth except extracted premolars 3) Undergoing upper and lower fixed orthodontic treatment with Roth prescription 0.022-inch metal brackets . 4) Finishing arch wires present for at least two months
Key exclusion criteria (5 listed)
- The subjects with a previous history of facial or mandibular surgery or syndromes affecting the jaw or face .
- Patient with history of jaw sugeries.
- Patients with history of taking medicine periodically or in the last 24 hours (eg, painkillers, corticosteroids, and antiflu drugs),
- Patient with history of debonded brackets and replacement.
- Patient with history of tooth transplantation or microscrews placement.
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 |
|---|---|---|
| Stabilization of teeth during debonding using fingure pressure and elastic waferTo control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording. | Other | finger pressure group, plastic wafers group |
Primary outcome
Measurement of pain
Time frame: Immediatey after debonding
Using visual analogue scale pain was measured
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 2 Nov 2021.
- 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.
Zahra Khalid, BDS, FCPSII study chair
AFID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization of teeth during debonding using fingure pressure and elastic wafer in people with Analgesia and Orthodontic Appliance Complication, run by Armed Forces Institute of Dentistry, Pakistan 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 1 inclusion and 5 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 2 Nov 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 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?
Measurement of pain (time frame: Immediatey after debonding). 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 2 Nov 2021.