Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures

Not Applicable

Completed

• Conditions: Impacted Canine
• Interventions: Procedure: Corticotomy; Device: Fixed appliances

• Registration Number: NCT05644678
• Lead Sponsor: Damascus University

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 :

1. conventional treatment group

2. minimally-invasive corticotomy-assisted treatment group Patients will be allocated to the two groups randomly. Data will be collected using periodontal variables.

Study Timeline

• Study Start: 2018-09-23
• Primary Completion: 2019-12-13
• Study Completion: 2022-11-15
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Status Verified: 2022-12
• Study First Posted: 2022-12-09
• Last Update Submitted: 2022-12-11
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age of patients: 18-28 years.
2. Palatal or Mid-alveolar impacted canine.
3. There is no previous orthodontic treatment.
4. Healthy periodontal tissues and good oral health (i.e., the Plaque Index is less or equal to 1 according to Loe and Silness(1963).
5. The patient does not take any drug that may interfere with the tooth movement (Cortisone, NSAIDs ...).
6. Mild or no crowding on the upper jaw.
7. No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria

1. Any systemic diseases that would affect tooth movement
2. Antidepressant prevents oral surgery
3. Any congenital syndromes or cleft lip and palate cases
4. Bad oral health
5. Previous orthodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgically-assisted treatment	Corticotomy	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.
Conventional treatment	Fixed appliances	Patients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance

Primary Outcome Measures

Name	Time	Method
Changes in the periodontal pocket depth (PPD)	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.
Changes in the width of the keratinized tissue (KT)	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
Changes in the gingival margin (GM)	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the Gingival Index (GI)	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.; 1. Mild inflammation: slight color change, slight edema, No bleeding on probing.; 2. Moderate inflammation: redness, edema and glazing. Bleeding on probing.; 3. Severe inflammation: marked redness and edema. Tendency to spontaneous bleeding. Ulceration.
Changes in the Bleeding Index (BI)	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.; 1. Bleeding some seconds after probing.; 2. Bleeding immediately after probing.; 3. Bleeding on probing spreading towards the marginal gingiva.

Trial Locations

Locations (1)

University of Damascus; 🇸🇾 Damascus, Syrian Arab Republic