Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT01917604
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction
Sponsor:
Jamia Millia Islamia
Organization:
Study Overview
Official Title:
Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
1. Generation of the random allocation sequence, including details of any restrictions.
2. Allocation concealment.
3. 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:
1. 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)
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).
3. Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).
4. Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3
Proper randomization procedures and reporting include the following steps.
1. Generation of the random allocation sequence, including details of any restrictions.
2. Allocation concealment.
3. 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:
1. 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)
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).
3. Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).
4. Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: