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Open Versus Closed Surgical Exposure of Impacted Canine Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01917604
Recruitment Status : Recruiting
First Posted : August 6, 2013
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
DR.PANCHALI BATRA, Jamia Millia Islamia

Brief Summary:
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 or disease Intervention/treatment Phase
Tooth, Impacted Procedure: open exposure Procedure: closed exposure Not Applicable

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.


  • 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.


• 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open Versus Closed Surgical Exposure of Impacted Canine Teeth-A Randomised Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measure of width of attached Gingiva. [ Time Frame: 36 months ]
    many measures which assess the periodontal outcome like crown length,gingival recession,bone loss will be assesed

Secondary Outcome Measures :
  1. pain score on the visual analogue scale [ Time Frame: 10 days post surgery ]
    many patient related outcomes like the number of times the bond failure took place,surgical time,pain associated with surgery will be assessed

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01917604

Contact: panchali batra, m.d.s. +91-9999908022

Jamia Millia Islamia Recruiting
Delhi, India, 110025
Contact: panchali batra, m.d.s.         
Principal Investigator: panchali batra, m.d.s.         
Sponsors and Collaborators
Jamia Millia Islamia
Principal Investigator: panchali batra, m.d.s. Jamia Millia Islamia

Publications of Results:
Responsible Party: DR.PANCHALI BATRA, Open versus Closed Surgical exposure of impacted canine-A randomised controlled trial, Jamia Millia Islamia Identifier: NCT01917604     History of Changes
Other Study ID Numbers: imc25
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by DR.PANCHALI BATRA, Jamia Millia Islamia:
open versus closed surgical technique
impacted maxillary canine
orthodontic disimpaction

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