Tooth, Impacted Clinical Trial
Official title:
Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
Verified date | September 2023 |
Source | Jamia Millia Islamia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility | Inclusion Criteria:Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment - Age 13-25 years Minimal orthodontic problems other than the ectopic canine - Good oral hygiene and motivated to wear fixed appliances for at least 2 years Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
India | Jamia Millia Islamia | Delhi |
Lead Sponsor | Collaborator |
---|---|
Jamia Millia Islamia | Council of Scientific and Industrial Research, India |
India,
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. E — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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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