Clinical trial NCT05644678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Canine
Keywords: Impacted canine
accelerate canine traction
periodontal index
periodontal status
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the periodontal pocket depth (PPD)
timeFrame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
measure: Changes in the gingival margin (GM)
timeFrame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
measure: Changes in the width of the keratinized tissue (KT)
timeFrame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Secondary outcomes:
measure: Changes in the Gingival Index (GI)
timeFrame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
measure: Changes in the Bleeding Index (BI)
timeFrame: Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Mahran R Mousa, DDS,MSc
role: STUDY_CHAIR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y. Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of oral and maxillofacial surgery, Damascus University, Syriam
name: Omar Heshmeh, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.