Open Versus Closed Surgical Exposure of Impacted Canine Teeth

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Jamia Millia Islamia
Sponsor:
Information provided by (Responsible Party):
DR.PANCHALI BATRA, Jamia Millia Islamia
ClinicalTrials.gov Identifier:
NCT01917604
First received: August 1, 2013
Last updated: August 4, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Tooth, Impacted
Procedure: open exposure
Procedure: closed exposure

Study Type: Interventional
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

Further study details as provided by Jamia Millia Islamia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  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 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).

  Eligibility

Ages Eligible for Study:   13 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917604

Contacts
Contact: panchali batra, m.d.s. +91-9999908022 panchali.batra@gmail.com

Locations
India
Jamia Millia Islamia Not yet recruiting
Delhi, India, 110025
Contact: panchali batra, m.d.s.         
Principal Investigator: panchali batra, m.d.s.         
Sponsors and Collaborators
Jamia Millia Islamia
Investigators
Principal Investigator: panchali batra, m.d.s. Jamia Millia Islamia
  More Information

Publications:
Responsible Party: DR.PANCHALI BATRA, Open versus Closed Surgical exposure of impacted canine-A randomised controlled trial, Jamia Millia Islamia
ClinicalTrials.gov Identifier: NCT01917604     History of Changes
Other Study ID Numbers: imc25
Study First Received: August 1, 2013
Last Updated: August 4, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Jamia Millia Islamia:
open versus closed surgical technique
impacted maxillary canine
orthodontic disimpaction

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014