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| Name | Class |
|---|---|
| Council of Scientific and Industrial Research, India | OTHER_GOV |
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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.
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.
information on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.
OPEN SURGICAL EXPOSURE
CLOSED SURGICAL EXPOSURE
• Surgically uncover the canine tooth and Surgical bone removal exposing the largest diameter of the ectopic canine crown.
Outcome Assessment:
The following outcomes will be measured before, during and post orthodontic treatment:
Primary Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| closed exposure and control | Experimental | raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open exposure | Procedure | the open surgical methods of exposing the canine is compared with control |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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. | Three month post debond |
| Maxillary canine aesthetic index (Annexure 1; page 7) | comparision to control side with experimental side of both the groups | one month after debond |
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Inclusion Criteria:Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment
Exclusion Criteria:
Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)
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| Name | Affiliation | Role |
|---|---|---|
| panchali batra, m.d.s. | Jamia Millia Islamia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jamia Millia Islamia | Delhi | 110025 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22677328 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 1, 2021 | May 6, 2022 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| closed exposure | Procedure | closed exposure is compared with control |
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