PainNCT05904587
Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance
A study testing SureSmile® VPro™, ortho technology, sports advantage, thermal forming soft EVA 3mm and cotton roll in people with Pain, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- SureSmile® VPro™, ortho technology, sports advantage, thermal forming soft EVA 3mm and cotton roll
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIraq
- Study dates
- 19 Mar 2023to 1 Nov 2023
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between 15-30 years of age who could understand, assess, and answer the questionnaires.
- No history of taking medicine periodically or in the last 24 hours (e.g., painkillers, corticosteroids, and anti-flu drugs).
- No debonded brackets prior to debonding procedure.
- No missing teeth except extracted premolar.
- Undergoing upper and lower fixed orthodontic treatment with 0.022-inch metal brackets.
- Finishing arch wires present for at least two months.
- No craniofacial deformities that would affect the dentoalveolar bone quality (e.g., cleft lip and palate) .
Who cannot join
- History of taking medicine periodically or in the last 24 h (e.g., analgesic, anti-inflammatory and anxiolytic).
- GAD-7 score of ˃8.
- Debonded brackets at the time of debonding.
- Missing teeth except for extracted premolars.
- Active periodontal problems (recession and mobility greater than Grade I),
- Heavily restored or root canal treated tooth.
Show all 9Show fewer
- Craniofacial deformities that would affect dentoalveolar bone quality (e.g., cleft lip and palate).
- Surgical treatment (including impacted tooth removal) and presence of mini-screws.
- excessive gingival overgrowth.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad
Baghdad, Bab Al-Muadham, 10047
Dheaa H Al-Groosh, Prof., 7737776503 ext. +964, d.al-groosh@codental.uobaghdad.edu.iq
About this study
Official title: Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance: a Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance.
The main question it aims to answer is which method (biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, and the use of low-level vibration in reducing pain during the debonding procedure) is most effective in reducing the patients' pain during debonding of conventional orthodontic fixed appliances.
Read more
Participants will be asked to give their pain score on a scale of 0 to 100 VAS (visual analogue scale) for every region of the dentition.
the researcher then will compare different scores of different methods to find the most effective method in reducing pain.
Read the detailed description
After signing the consent form, the patient will be tested using General Anxiety Disorder 7 (GAD-7) to reduce the effect of general anxiety on pain scores. GAD consists of 7 statements designed to measure anxiety. This will aid in identifying individuals who have severe anxiety disorder and exclude them from the study to ensure more accurate results.
Four debonding methods will be used in this study; Routine mechanical debonding with debonding plier with an open mouth, which will be used as control, and three other interventions to manage pain including biting on a cotton roll, biting on an elastomeric wafer, and using vibration. All of the procedures will be done with the archwire in situ and with minimal torsional force on the bracket.
For the control group, the debonding will be done with an open-mouth technique without any support applied to the teeth. The cotton roll method will be done by asking the patient to bite on the cotton roll firmly but not excessively during the debonding procedure.
As for the elastomeric wafer group the patient will bite on the wafer firmly during the debonding procedure, in a similar fashion the patient will bite on the mouthpiece of the VPro vibration device.
Pain will be estimated by using 100mm VAS and recording the results for each sextant, accompanied by the GAD-7 results and the patient's age and gender.
- Conditions
- Pain
- Being tested
- SureSmile® VPro™, ortho technology, sports advantage, thermal forming soft EVA 3mm, cotton roll
- Keywords
- pain and debonding
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureSmile® VPro™Device
the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure
ortho technology, sports advantage, thermal forming soft EVA 3mmOther
the pain is recorded when the patient is biting on the EVA sheet during the debonding procedure
cotton rollOther
the pain is recorded when the patient is biting on the cotton roll during the debonding procedure
| Study group | Role | What they receive |
|---|---|---|
| open mouth debonding | No intervention | debonding of the bracket is done while the mouth of the patient is open and without any support to the teeth during the debonding procedure |
| biting on soft elastomeric wafer | Experimental | debonding of the bracket is done while the patient is biting on the preshaped soft elastomeric wafer (cut into a horseshoe shape) during the debonding procedure Receives: Other: ortho technology, sports advantage, thermal forming soft EVA 3mm |
| biting on cotton roll | Experimental | debonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure Receives: Other: cotton roll |
| biting on the mouthpiece of vibrational device | Experimental | debonding of the bracket is done while the patient is biting on the mouthpiece of the vibrational device (SureSmile® VPro™) delivering vibrations to the dentition during the debonding procedure Receives: Device: SureSmile® VPro™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during debonding of conventional fixed orthodontic appliance
pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure
Measured: Intraprocedural
Secondary outcomes (1)
the dentition segment with the highest pain scores
will be measured statistically
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start19 Mar 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alhasan Ibraheem Ali, University of Baghdad
- Investigators
- Ammar S Kadhum, Asst. Prof., Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904587
- Sponsor's protocol ID
- 780423
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with an academic interest in pain and debonding of conventional fixed orthodontic appliances. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Almuzian M, Rizk MZ, Ulhaq A, Alharbi F, Alomari S, Mohammed H. Effectiveness of different debonding techniques and adjunctive methods on pain and discomfort perception during debonding fixed orthodontic appliances: a systematic review. Eur J Orthod. 2019 Sep 21;41(5):486-494. doi: 10.1093/ejo/cjz013.
PubMed 30934051Bavbek NC, Tuncer BB, Tortop T, Celik B. Efficacy of different methods to reduce pain during debonding of orthodontic brackets. Angle Orthod. 2016 Nov;86(6):917-924. doi: 10.2319/020116-88R.1. Epub 2016 May 12.
PubMed 27172508Celebi, F. (2021) Evaluation of the effects of cotton roll-biting on debonding pain: a split-mouth study. South European Journal of Orthodontics And Dentofacial Research, 8, 1-7.
Gupta SP, Rauniyar S, Prasad P, Pradhan PMS. A randomized controlled trial to evaluate the effectiveness of different methods on pain management during orthodontic debonding. Prog Orthod. 2022 Mar 1;23(1):7. doi: 10.1186/s40510-022-00401-y.
PubMed 35229220Jaypapal, J., Maheshwari, U. and Vijayalakshmi, V. (2020) Comparison of pain perception during debonding between conventional and vibratory therapy. Annals of the Romanian Society for Cell Biology, 24, 701-715.
Kilinc DD, Sayar G. Evaluation of pain perception during orthodontic debonding of metallic brackets with four different techniques. J Appl Oral Sci. 2019 Jan 7;27:e20180003. doi: 10.1590/1678-7757-2018-0003.
PubMed 30624460Pithon MM, Santos Fonseca Figueiredo D, Oliveira DD, Coqueiro Rda S. What is the best method for debonding metallic brackets from the patient's perspective? Prog Orthod. 2015;16:17. doi: 10.1186/s40510-015-0088-7. Epub 2015 Jun 17.
PubMed 26081783Williams OL, Bishara SE. Patient discomfort levels at the time of debonding: a pilot study. Am J Orthod Dentofacial Orthop. 1992 Apr;101(4):313-7. doi: 10.1016/S0889-5406(05)80324-5.
PubMed 1558060Musawi AI, Kadhum AS. Effectiveness of high-frequency vibration, cotton rolls and elastomeric wafers in alleviating debonding pain of orthodontic metal brackets: a randomized clinical trial. Sci Rep. 2024 Oct 24;14(1):25160. doi: 10.1038/s41598-024-75725-2.
PubMed 39448724
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05904587
- Acronym / sponsor ID
- 780423
- Conditions
- Pain
- Keywords
- pain and debonding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 15 Jun 2023 (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 goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance.
The main question it aims to answer is which method (biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, and the use of low-level vibration in reducing pain during the debonding procedure) is most effective in reducing the patients' pain during debonding of conventional orthodontic fixed appliances.
Participants will be asked to give their pain score on a scale of 0 to 100 VAS (visual analogue scale) for every region of the dentition.
the researcher then will compare different scores of different methods to find the most effective method in reducing pain.
Detailed description
After signing the consent form, the patient will be tested using General Anxiety Disorder 7 (GAD-7) to reduce the effect of general anxiety on pain scores. GAD consists of 7 statements designed to measure anxiety. This will aid in identifying individuals who have severe anxiety disorder and exclude them from the study to ensure more accurate results.
Four debonding methods will be used in this study; Routine mechanical debonding with debonding plier with an open mouth, which will be used as control, and three other interventions to manage pain including biting on a cotton roll, biting on an elastomeric wafer, and using vibration. All of the procedures will be done with the archwire in situ and with minimal torsional force on the bracket.
For the control group, the debonding will be done with an open-mouth technique without any support applied to the teeth. The cotton roll method will be done by asking the patient to bite on the cotton roll firmly but not excessively during the debonding procedure.
As for the elastomeric wafer group the patient will bite on the wafer firmly during the debonding procedure, in a similar fashion the patient will bite on the mouthpiece of the VPro vibration device.
Pain will be estimated by using 100mm VAS and recording the results for each sextant, accompanied by the GAD-7 results and the patient's age and gender.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| open mouth debonding | No intervention | –debonding of the bracket is done while the mouth of the patient is open and without any support to the teeth during the debonding procedure |
| biting on soft elastomeric wafer | Experimental | Other: ortho technology, sports advantage, thermal forming soft EVA 3mmdebonding of the bracket is done while the patient is biting on the preshaped soft elastomeric wafer (cut into a horseshoe shape) during the debonding procedure |
| biting on cotton roll | Experimental | Other: cotton rolldebonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure |
| biting on the mouthpiece of vibrational device | Experimental | Device: SureSmile® VPro™debonding of the bracket is done while the patient is biting on the mouthpiece of the vibrational device (SureSmile® VPro™) delivering vibrations to the dentition during the debonding procedure |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients between 15-30 years of age who could understand, assess, and answer the questionnaires.
- No history of taking medicine periodically or in the last 24 hours (e.g., painkillers, corticosteroids, and anti-flu drugs).
- No debonded brackets prior to debonding procedure.
- No missing teeth except extracted premolar.
- Undergoing upper and lower fixed orthodontic treatment with 0.022-inch metal brackets.
Key exclusion criteria (9 listed)
- History of taking medicine periodically or in the last 24 h (e.g., analgesic, anti-inflammatory and anxiolytic).
- GAD-7 score of ˃8.
- Debonded brackets at the time of debonding.
- Missing teeth except for extracted premolars.
- Active periodontal problems (recession and mobility greater than Grade I),
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 |
|---|---|---|
| SureSmile® VPro™the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure | Device | biting on the mouthpiece of vibrational device |
| ortho technology, sports advantage, thermal forming soft EVA 3mmthe pain is recorded when the patient is biting on the EVA sheet during the debonding procedure | Other | biting on soft elastomeric wafer |
| cotton rollthe pain is recorded when the patient is biting on the cotton roll during the debonding procedure | Other | biting on cotton roll |
Primary outcome
pain during debonding of conventional fixed orthodontic appliance
Time frame: Intraprocedural
pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure
1 secondary outcome
the dentition segment with the highest pain scores
Time frame: Intraprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 30934051Almuzian M, Rizk MZ, Ulhaq A, Alharbi F, Alomari S, Mohammed H. Effectiveness of different debonding techniques and adjunctive methods on pain and discomfort perception during debonding fixed orthodontic appliances: a systematic review. Eur J Orthod. 2019 Sep 21;41(5):486-494. doi: 10.1093/ejo/cjz013.
- Background: PubMed 27172508Bavbek NC, Tuncer BB, Tortop T, Celik B. Efficacy of different methods to reduce pain during debonding of orthodontic brackets. Angle Orthod. 2016 Nov;86(6):917-924. doi: 10.2319/020116-88R.1. Epub 2016 May 12.
- BackgroundCelebi, F. (2021) Evaluation of the effects of cotton roll-biting on debonding pain: a split-mouth study. South European Journal of Orthodontics And Dentofacial Research, 8, 1-7.
- Background: PubMed 35229220Gupta SP, Rauniyar S, Prasad P, Pradhan PMS. A randomized controlled trial to evaluate the effectiveness of different methods on pain management during orthodontic debonding. Prog Orthod. 2022 Mar 1;23(1):7. doi: 10.1186/s40510-022-00401-y.
- BackgroundJaypapal, J., Maheshwari, U. and Vijayalakshmi, V. (2020) Comparison of pain perception during debonding between conventional and vibratory therapy. Annals of the Romanian Society for Cell Biology, 24, 701-715.
- Background: PubMed 30624460Kilinc DD, Sayar G. Evaluation of pain perception during orthodontic debonding of metallic brackets with four different techniques. J Appl Oral Sci. 2019 Jan 7;27:e20180003. doi: 10.1590/1678-7757-2018-0003.
- Background: PubMed 26081783Pithon MM, Santos Fonseca Figueiredo D, Oliveira DD, Coqueiro Rda S. What is the best method for debonding metallic brackets from the patient's perspective? Prog Orthod. 2015;16:17. doi: 10.1186/s40510-015-0088-7. Epub 2015 Jun 17.
- Background: PubMed 1558060Williams OL, Bishara SE. Patient discomfort levels at the time of debonding: a pilot study. Am J Orthod Dentofacial Orthop. 1992 Apr;101(4):313-7. doi: 10.1016/S0889-5406(05)80324-5.
- Derived from this study: PubMed 39448724Musawi AI, Kadhum AS. Effectiveness of high-frequency vibration, cotton rolls and elastomeric wafers in alleviating debonding pain of orthodontic metal brackets: a randomized clinical trial. Sci Rep. 2024 Oct 24;14(1):25160. doi: 10.1038/s41598-024-75725-2.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with an academic interest in pain and debonding of conventional fixed orthodontic appliances. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Ammar S Kadhum, Asst. Prof. study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureSmile® VPro™, ortho technology, sports advantage, thermal forming soft EVA 3mm and cotton roll in people with Pain, 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alhasan I Ali, B.D.S. (7505959112 ext. +964, alhassan.ali22031@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during debonding of conventional fixed orthodontic appliance (time frame: Intraprocedural). 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 NCT05904587, which also lists 9 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 15 Jun 2023.