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

Impacted Canine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644678
• Other study ID #: UDDS-Ortho-15-2022
• Status: Completed
• Phase: N/A
• Start date: September 23, 2018
• Est. completion date: November 15, 2022

Study information

• Verified date: December 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 15, 2022
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Canine
• Tooth, Impacted

Intervention

Device:
• Fixed appliances
Metal brackets with a straight-wire prescription will be used. Patients will be treated conventionally.

Procedure:
• Corticotomy
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.

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment
Secondary	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.	Time 1: immediately before the surgical exposure; Time 2: immediately at the end of the active treatment