Tooth, ImpactedNCT01917604
Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction
A study testing open exposure and closed exposure in people with Tooth, Impacted, run by Jamia Millia Islamia at 1 site in India.
Trial summary
To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- open exposure and closed exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2022to Jan 2025
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)
- Periodontal disease (bleeding on probing, pocket probing depths _3 mm and decreased bone levels as diagnosed from baseline panoramic imaging)
- Cases in which the canine is to be brought into the position of the lateral incisor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.
Read the detailed description
The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. The protocol has been approved by local ethics committee of Jamia Millia Islamia and all participants will be provided with an informed consent agreement. The settings will be the orthodontic department of a dental teaching hospital (Faculty of Dentistry, Jamia Millia Islamia). Participants for the trial will be identified from treatment waiting lists and new patient clinics.
Proper randomization procedures and reporting include the following steps.
- Generation of the random allocation sequence, including details of any restrictions.
- Allocation concealment.
- Implementation of the random allocation sequence: information on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.
OPEN SURGICAL EXPOSURE
- Surgically uncover the canine tooth followed by bone removal exposing the largest diameter of the ectopic canine crown. The edges need to be substantially trimmed back and dental follicle removed to prevent reclosure of the very thick palatal mucosa.
- Surgical excision of the palatal mucosa-standardized using a preformed wire template.
- Coe-pack surgical dressing (GC America Inc, Alsip, IL) will be left in place.
- The patient will be reviewed 10 days later and the surgical pack removed and the bracket bonded and force application started once the tooth has erupted sufficiently for an orthodontic attachment to be glued onto its surface, orthodontic brace treatment is commenced to bring the tooth into line.
CLOSED SURGICAL EXPOSURE
- Surgically uncover the canine tooth and Surgical bone removal exposing the largest diameter of the ectopic canine crown.
- An multipurpose attachment with ligature wire and e chain will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).
- An orthodontic attachment (button) with ligature wire and bracket with closed coil spring will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).
Outcome Assessment:
The following outcomes will be measured before, during and post orthodontic treatment:
Primary Outcome Measures:
- Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire pre-treatment and post treatment (one month after debond) -(Annexure 1 - page 1,2)
- Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire 24 hrs and 10 days after surgical caniine exposure (Annexure 1 - page 3,4).
- Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).
- Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3
- Conditions
- Tooth, Impacted
- Being tested
- open exposure, closed exposure
- Keywords
- Open versus Closed surgical technique, Palatally impacted maxillary canine, Orthodontic disimpaction, Oral health related Quality of life
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open exposureProcedure or surgery
the open surgical methods of exposing the canine is compared with control
closed exposureProcedure or surgery
closed exposure is compared with control
| Study group | Role | What they receive |
|---|---|---|
| open exposure and control | Experimental | ● surgically uncover the canine tooth and bone removal exposing the largest diameter of the ectopic canine crown make a window in the palatal soft tissue and bond bracket after 10 days Receives: Procedure: open exposure |
| closed exposure and control | Experimental | raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap Receives: Procedure: closed exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health based Quality of life (Annexure 1; page 1 and page 2)
to evaluate change in Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both groups
Measured: pre-treatment and 1 month post treatment (average duration of treatment 18 months )
Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Measured: 24 hours after surgical exposure
Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Measured: 10th day after surgical exposure
Clinical outcomes - periodontal (Annexure 1; page 5)
Periodontal outcomes of disimpacted canines accessed clinically and compared for both open and closed groups; contralateral canine of maxillary arch will be control group.
Measured: Three month post debond
Maxillary canine aesthetic index (Annexure 1; page 7)
comparision to control side with experimental side of both the groups
Measured: one month after debond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study start5 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth, ImpactedStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamia Millia Islamia
- Sponsor type
- University, hospital or other
- Collaborators
- Council of Scientific and Industrial Research, India
- Responsible party
- Principal investigator, DR.PANCHALI BATRA, Jamia Millia Islamia
- Investigators
- panchali batra, m.d.s., Principal investigator, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917604
- Sponsor's protocol ID
- imc25
- Status last verified
- Sep 2023
- First submitted
- 1 Aug 2013
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parkin NA, Deery C, Smith AM, Tinsley D, Sandler J, Benson PE. No difference in surgical outcomes between open and closed exposure of palatally displaced maxillary canines. J Oral Maxillofac Surg. 2012 Sep;70(9):2026-34. doi: 10.1016/j.joms.2012.02.028. Epub 2012 Jun 6.
PubMed 22677328
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01917604
- Acronym / sponsor ID
- imc25
- Conditions
- Tooth, Impacted
- Keywords
- Open versus Closed surgical technique, Palatally impacted maxillary canine, Orthodontic disimpaction, Oral health related Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Collaborators
- Council of Scientific and Industrial Research, India
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- 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.
To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.
Detailed description
The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. The protocol has been approved by local ethics committee of Jamia Millia Islamia and all participants will be provided with an informed consent agreement. The settings will be the orthodontic department of a dental teaching hospital (Faculty of Dentistry, Jamia Millia Islamia). Participants for the trial will be identified from treatment waiting lists and new patient clinics.
Proper randomization procedures and reporting include the following steps.
- Generation of the random allocation sequence, including details of any restrictions.
- Allocation concealment.
- Implementation of the random allocation sequence: information on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.
OPEN SURGICAL EXPOSURE
- Surgically uncover the canine tooth followed by bone removal exposing the largest diameter of the ectopic canine crown. The edges need to be substantially trimmed back and dental follicle removed to prevent reclosure of the very thick palatal mucosa.
- Surgical excision of the palatal mucosa-standardized using a preformed wire template.
- Coe-pack surgical dressing (GC America Inc, Alsip, IL) will be left in place.
- The patient will be reviewed 10 days later and the surgical pack removed and the bracket bonded and force application started once the tooth has erupted sufficiently for an orthodontic attachment to be glued onto its surface, orthodontic brace treatment is commenced to bring the tooth into line.
CLOSED SURGICAL EXPOSURE
- Surgically uncover the canine tooth and Surgical bone removal exposing the largest diameter of the ectopic canine crown.
- An multipurpose attachment with ligature wire and e chain will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).
- An orthodontic attachment (button) with ligature wire and bracket with closed coil spring will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).
Outcome Assessment:
The following outcomes will be measured before, during and post orthodontic treatment:
Primary Outcome Measures:
- Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire pre-treatment and post treatment (one month after debond) -(Annexure 1 - page 1,2)
- Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire 24 hrs and 10 days after surgical caniine exposure (Annexure 1 - page 3,4).
- Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).
- Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open exposure and control | Experimental | Procedure: open exposure● surgically uncover the canine tooth and bone removal exposing the largest diameter of the ectopic canine crown make a window in the palatal soft tissue and bond bracket after 10 days |
| closed exposure and control | Experimental | Procedure: closed exposureraising a flap in the area of impacted canine,bonding an attachment and resuturing the flap |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)
- Periodontal disease (bleeding on probing, pocket probing depths _3 mm and decreased bone levels as diagnosed from baseline panoramic imaging)
- Cases in which the canine is to be brought into the position of the lateral incisor.
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 |
|---|---|---|
| open exposurethe open surgical methods of exposing the canine is compared with control | Procedure or surgery | open exposure and control |
| closed exposureclosed exposure is compared with control | Procedure or surgery | closed exposure and control |
Primary outcome
Oral health based Quality of life (Annexure 1; page 1 and page 2)
Time frame: pre-treatment and 1 month post treatment (average duration of treatment 18 months )
to evaluate change in Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both groups
Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)
Time frame: 24 hours after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
Time frame: 10th day after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Clinical outcomes - periodontal (Annexure 1; page 5)
Time frame: Three month post debond
Periodontal outcomes of disimpacted canines accessed clinically and compared for both open and closed groups; contralateral canine of maxillary arch will be control group.
Maxillary canine aesthetic index (Annexure 1; page 7)
Time frame: one month after debond
comparision to control side with experimental side of both the groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 22677328Parkin NA, Deery C, Smith AM, Tinsley D, Sandler J, Benson PE. No difference in surgical outcomes between open and closed exposure of palatally displaced maxillary canines. J Oral Maxillofac Surg. 2012 Sep;70(9):2026-34. doi: 10.1016/j.joms.2012.02.028. Epub 2012 Jun 6.
- 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.
panchali batra, m.d.s. principal investigator
Jamia Millia Islamia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open exposure and closed exposure in people with Tooth, Impacted, run by Jamia Millia Islamia at 1 site in India.
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 0 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: status not confirmed, as of the sponsor's last update on 28 Sep 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 India. 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?
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?
Oral health based Quality of life (Annexure 1; page 1 and page 2) (time frame: pre-treatment and 1 month post treatment (average duration of treatment 18 months )). The study lists 5 primary outcomes in all. 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 NCT01917604, which also lists 1 linked publication.
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 28 Sep 2023.