NCT01917604

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
8.4 years until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

August 1, 2013

Last Update Submit

September 27, 2023

Conditions

Tooth, Impacted

Keywords

Open versus Closed surgical techniquePalatally impacted maxillary canineOrthodontic disimpactionOral health related Quality of life

Outcome Measures

Primary Outcomes (5)

  • 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 )

  • 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

  • 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

  • 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

  • Maxillary canine aesthetic index (Annexure 1; page 7)

    comparision to control side with experimental side of both the groups

    one month after debond

Study Arms (2)

open exposure and control

EXPERIMENTAL

● 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

closed exposure and control

EXPERIMENTAL

raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap

Procedure: closed exposure

Interventions

open exposurePROCEDURE

the open surgical methods of exposing the canine is compared with control

open exposure and control
closed exposurePROCEDURE

closed exposure is compared with control

closed exposure and control

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jamia Millia Islamia

Delhi, 110025, India

Location

Related Publications (1)

  • 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. Epub 2012 Jun 6.

    PMID: 22677328RESULT

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • panchali batra, m.d.s.

    Jamia Millia Islamia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Orthodontics

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 6, 2013

Study Start

January 5, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)