Open Versus Closed Surgical Exposure of Impacted Canine Teeth
To test the null hypothesis that there are no differences in the outcomes between using an open or closed surgical method to expose canines that have become displaced in the roof of the mouth.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Open Versus Closed Surgical Exposure of Impacted Canine Teeth-A Randomised Controlled Trial|
- Measure of width of attached Gingiva. [ Time Frame: 36 months ] [ Designated as safety issue: No ]many measures which assess the periodontal outcome like crown length,gingival recession,bone loss will be assesed
- pain score on the visual analogue scale [ Time Frame: 10 days post surgery ] [ Designated as safety issue: No ]many patient related outcomes like the number of times the bond failure took place,surgical time,pain associated with surgery will be assessed
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: open exposure and control
● 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
Procedure: open exposure
the open surgical methods of exposing the canine is compared with control
Experimental: closed exposure and control
raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap
Procedure: closed exposure
closed exposure is compared with control
The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. It will be approved by local ethics committees of Jamia Millia Islamia and all participants signed will sign an informed consent agreement. The settings will be the orthodontic departments of 1 dental teaching hospital (Jamia Millia Islamia Dental hospital) 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 and 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. For a deeply buried and palatally displaced tooth, the exposure will additionally need to be maintained using surgical pack.
- Surgical excision of the palatal mucosa—standardized using a preformed wire template.
- Surgical gauze soaked in Whitehead varnish (iodoform 10 g, benzoin 10 g, prepared storax 7.5 g, tolu balsam 5 g, and solvent ether to 100 ml) or Coe-pack surgical dressing was sutured 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).
- The palatal mucosa was sutured back intact with the gold chain extending through an incision in the palatal flap.
Chlorhexidine digluconate 0.2% w/v mouthwash was prescribed after surgery (10 mL 3 times per day for 7 days, starting 4 hrs after surgery). OUTCOMES Definition of successful outcome The successful outcome for palatally displaced canine was defined as the full eruption of the tooth, thus permitting bracket positioning for final arch alignment when needed. Unsuccessful outcome was represented by the lack of eruption of the permanent canine (impaction) at the completion of the clinical observation period (48 months after the initial observation).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917604
|Contact: panchali batra, firstname.lastname@example.org|
|Jamia Millia Islamia||Not yet recruiting|
|Delhi, India, 110025|
|Contact: panchali batra, m.d.s.|
|Principal Investigator: panchali batra, m.d.s.|
|Principal Investigator:||panchali batra, m.d.s.||Jamia Millia Islamia|