Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
December 11, 2022 updated by: Damascus University
Comparison of Posttreatment Periodontal Status of Palatally Impacted Canines Aligned by Conventional Versus Accelerated Minimally-invasive Corticotomy-assisted Orthodontic Traction Treatment: A Randomized Controlled Trial
Impacted canine causes many problems for patients, such as damage to the adjacent teeth roots, effects on gingival tissues, aesthetic problems, difficulty, and prolonged orthodontic treatment duration.
Therefore, solutions to accelerate the movement of impacted canines with the help of surgical procedures to reduce treatment time will be investigated, such as intra-operative alveolar perforations and piezocision.
We also aimed to evaluate periodontal changes associated with such accelerating procedures compared with the conventional traction method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with palatally impacted maxillary canines will be treated using fixed appliances assisted by some surgical procedures. The effects of this treatment approach on the periodontal status will be assessed using periodontal measurements.
There are two groups :
- conventional treatment group
- minimally-invasive corticotomy-assisted treatment group Patients will be allocated to the two groups randomly. Data will be collected using periodontal variables.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Damascus, Syrian Arab Republic
- University of Damascus
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of patients: 18-28 years.
- Palatal or Mid-alveolar impacted canine.
- There is no previous orthodontic treatment.
- Healthy periodontal tissues and good oral health (i.e., the Plaque Index is less or equal to 1 according to Loe and Silness(1963).
- The patient does not take any drug that may interfere with the tooth movement (Cortisone, NSAIDs …).
- Mild or no crowding on the upper jaw.
- No history of previous trauma to the maxillofacial region or surgical interventions.
Exclusion Criteria:
- Any systemic diseases that would affect tooth movement
- Antidepressant prevents oral surgery
- Any congenital syndromes or cleft lip and palate cases
- Bad oral health
- Previous orthodontic treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional treatment
Patients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance
|
Metal brackets with a straight-wire prescription will be used.
Patients will be treated conventionally.
|
|
Experimental: Surgically-assisted treatment
Patients will be treated using fixed appliances assisted by minimally-invasive corticotomy (alveolar perforations and piezocision) to accelerate impacted canines' traction after opening the appropriate distance.
|
Patients will be treated in conjunction with a surgical intervention using metal brackets with a straight-wire prescription.
Corticotomy (alveolar perforation and piezocision) will induce acceleration in canine traction movement during the orthodontic treatment in only one group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the periodontal pocket depth (PPD)
Time Frame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
The distance from the gingival margin to the base of the pocket of the first premolar, canine, and lateral incisor.
|
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
|
Changes in the gingival margin (GM)
Time Frame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
The distance from the cementoenamel junction (CEJ) to the gingival margin of the first premolar, canine, and lateral incisor.
|
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
|
Changes in the width of the keratinized tissue (KT)
Time Frame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
The distance from the gingival margin to the mucogingival junction of the first premolar, canine, and lateral incisor
|
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the Bleeding Index (BI)
Time Frame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
The healthiness of the gingival margin and the attached gingivae will be assessed depending on the status of gingival inflammation. 0= No bleeding.
|
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
|
Changes in the Gingival Index (GI)
Time Frame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
The gingival status will be assessed using the following classification 0= Normal gingiva.
|
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mahran R Mousa, DDS,MSc, Department of orthodontics, Damascus University, Syria
- Study Director: Mohammad Y. Hajeer, DDS,MSc,PhD, Department of orthodontics, Damascus University, Syria
- Study Director: Omar Heshmeh, DDS,MSc,PhD, Department of oral and maxillofacial surgery, Damascus University, Syriam
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smailiene D, Kavaliauskiene A, Pacauskiene I, Zasciurinskiene E, Bjerklin K. Palatally impacted maxillary canines: choice of surgical-orthodontic treatment method does not influence post-treatment periodontal status. A controlled prospective study. Eur J Orthod. 2013 Dec;35(6):803-10. doi: 10.1093/ejo/cjs102. Epub 2013 Jan 24.
- Parkin NA, Milner RS, Deery C, Tinsley D, Smith AM, Germain P, Freeman JV, Bell SJ, Benson PE. Periodontal health of palatally displaced canines treated with open or closed surgical technique: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):176-84. doi: 10.1016/j.ajodo.2013.03.016.
- Crescini A, Nieri M, Buti J, Baccetti T, Mauro S, Prato GP. Short- and long-term periodontal evaluation of impacted canines treated with a closed surgical-orthodontic approach. J Clin Periodontol. 2007 Mar;34(3):232-42. doi: 10.1111/j.1600-051X.2006.01042.x. Epub 2007 Jan 25.
- Pini Prato G, Baccetti T, Magnani C, Agudio G, Cortellini P. Mucogingival interceptive surgery of buccally-erupted premolars in patients scheduled for orthodontic treatment. I. A 7-year longitudinal study. J Periodontol. 2000 Feb;71(2):172-81. doi: 10.1902/jop.2000.71.2.172.
- Crescini A, Clauser C, Giorgetti R, Cortellini P, Pini Prato GP. Tunnel traction of infraosseous impacted maxillary canines. A three-year periodontal follow-up. Am J Orthod Dentofacial Orthop. 1994 Jan;105(1):61-72. doi: 10.1016/S0889-5406(94)70100-8.
- Zasciurinskiene E, Bjerklin K, Smailiene D, Sidlauskas A, Puisys A. Initial vertical and horizontal position of palatally impacted maxillary canine and effect on periodontal status following surgical-orthodontic treatment. Angle Orthod. 2008 Mar;78(2):275-80. doi: 10.2319/010907-8.1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2018
Primary Completion (Actual)
December 13, 2019
Study Completion (Actual)
November 15, 2022
Study Registration Dates
First Submitted
November 30, 2022
First Submitted That Met QC Criteria
November 30, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
December 13, 2022
Last Update Submitted That Met QC Criteria
December 11, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-Ortho-15-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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