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

NCT05644678 | Completed DMC

• 1 other identifier: UDDS-Ortho-15-2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Canine

Keywords

Impacted canine; accelerate canine traction; periodontal index; periodontal status

Outcome Measures

Primary Outcomes (3)

• 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.

  Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment

• 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.

  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)

  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 Outcomes (2)

• Changes in the Gingival Index (GI)

  Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment

• Changes in the Bleeding Index (BI)

  Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Patients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance

Device: Fixed appliances

Surgically-assisted treatment

EXPERIMENTAL

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.

Procedure: Corticotomy

Interventions

Fixed appliances DEVICE

Metal brackets with a straight-wire prescription will be used. Patients will be treated conventionally.

Conventional treatment

Corticotomy PROCEDURE

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.

Surgically-assisted treatment

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 23349422 BACKGROUND

• 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.

  PMID: 23910198 BACKGROUND

• 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.

  PMID: 17257160 BACKGROUND

• 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.

  PMID: 10711607 BACKGROUND

• 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.

  PMID: 8291494 BACKGROUND

• 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.

  PMID: 18251594 BACKGROUND

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Mahran R Mousa, DDS,MSc

  Department of orthodontics, Damascus University, Syria

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: September 23, 2018
• Primary Completion: December 13, 2019
• Study Completion: November 15, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)