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Completed

NCT Number: NCT05644678

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

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.

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Key information

Conditions

Impacted Canine

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed appliances

Device

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

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.

Primary outcomes

  1. Changes in the periodontal pocket depth (PPD)

    Time frame: 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.

  2. Changes in the gingival margin (GM)

    Time frame: 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.

  3. Changes in the width of the keratinized tissue (KT)

    Time frame: 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

Secondary outcomes

  1. Changes in the Gingival Index (GI)

    Time frame: 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.

    • 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.

  2. Changes in the Bleeding Index (BI)

    Time frame: 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.

    • Bleeding some seconds after probing.
    • Bleeding immediately after probing.
    • Bleeding on probing spreading towards the marginal gingiva.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Dec 9, 2022
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.