Back to resultsEvaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
Primary Purpose
Impacted Canine
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Fixed appliances
Corticotomy
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Canine focused on measuring Impacted canine, accelerate canine traction, periodontal index, periodontal status
Eligibility Criteria
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
Sites / Locations
- University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment
Surgically-assisted treatment
Arm Description
Patients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance
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.
Outcomes
Primary Outcome Measures
Changes in the periodontal pocket depth (PPD)
The distance from the gingival margin to the base of the pocket of the first premolar, canine, and lateral incisor.
Changes in the gingival margin (GM)
The distance from the cementoenamel junction (CEJ) to the gingival margin of the first premolar, canine, and lateral incisor.
Changes in the width of the keratinized tissue (KT)
The distance from the gingival margin to the mucogingival junction of the first premolar, canine, and lateral incisor
Secondary Outcome Measures
Changes in the Gingival Index (GI)
The gingival status will be assessed using the following classification 0= Normal gingiva.
Mild inflammation: slight color change, slight edema, No bleeding on probing.
Moderate inflammation: redness, edema and glazing. Bleeding on probing.
Severe inflammation: marked redness and edema. Tendency to spontaneous bleeding. Ulceration.
Changes in the Bleeding Index (BI)
The healthiness of the gingival margin and the attached gingivae will be assessed depending on the status of gingival inflammation.
0= No bleeding.
Bleeding some seconds after probing.
Bleeding immediately after probing.
Bleeding on probing spreading towards the marginal gingiva.
Full Information
NCT ID
NCT05644678
First Posted
November 30, 2022
Last Updated
December 11, 2022
Sponsor
Damascus University
1. Study Identification
Unique Protocol Identification Number
NCT05644678
Brief Title
Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Canine
Keywords
Impacted canine, accelerate canine traction, periodontal index, periodontal status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Patients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance
Arm Title
Surgically-assisted treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fixed appliances
Intervention Description
Metal brackets with a straight-wire prescription will be used. Patients will be treated conventionally.
Intervention Type
Procedure
Intervention Name(s)
Corticotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the periodontal pocket depth (PPD)
Description
The distance from the gingival margin to the base of the pocket of the first premolar, canine, and lateral incisor.
Time Frame
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Title
Changes in the gingival margin (GM)
Description
The distance from the cementoenamel junction (CEJ) to the gingival margin of the first premolar, canine, and lateral incisor.
Time Frame
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Title
Changes in the width of the keratinized tissue (KT)
Description
The distance from the gingival margin to the mucogingival junction of the first premolar, canine, and lateral incisor
Time Frame
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Secondary Outcome Measure Information:
Title
Changes in the Gingival Index (GI)
Description
The gingival status will be assessed using the following classification 0= Normal gingiva.
Mild inflammation: slight color change, slight edema, No bleeding on probing.
Moderate inflammation: redness, edema and glazing. Bleeding on probing.
Severe inflammation: marked redness and edema. Tendency to spontaneous bleeding. Ulceration.
Time Frame
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Title
Changes in the Bleeding Index (BI)
Description
The healthiness of the gingival margin and the attached gingivae will be assessed depending on the status of gingival inflammation.
0= No bleeding.
Bleeding some seconds after probing.
Bleeding immediately after probing.
Bleeding on probing spreading towards the marginal gingiva.
Time Frame
Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahran R Mousa, DDS,MSc
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omar Heshmeh, DDS,MSc,PhD
Organizational Affiliation
Department of oral and maxillofacial surgery, Damascus University, Syriam
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23349422
Citation
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.
Results Reference
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PubMed Identifier
23910198
Citation
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.
Results Reference
background
PubMed Identifier
17257160
Citation
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.
Results Reference
background
PubMed Identifier
10711607
Citation
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.
Results Reference
background
PubMed Identifier
8291494
Citation
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.
Results Reference
background
PubMed Identifier
18251594
Citation
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.
Results Reference
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Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
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