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Impacted CanineNCT05644678

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

A study testing Fixed appliances and Corticotomy in people with Impacted Canine, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 28 years
Conditions the study is for
Impacted Canine
What is being tested?
Fixed appliances and Corticotomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSyria
Study dates
23 Sep 2018to 15 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 28 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • University of Damascus

    Damascus

Other trials in Syria

About this study

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

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.

Read the 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.
Conditions
Impacted Canine
Being tested
Fixed appliances, Corticotomy
Keywords
Impacted canine, accelerate canine traction, periodontal index, periodontal status

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fixed appliancesDevice

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

  • CorticotomyProcedure or surgery

    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.

Study groups in NCT05644678
Study groupRoleWhat they receive
Conventional treatmentActive comparatorPatients will be treated using the fixed appliances to track the impacted canines after opening the appropriate distance
Receives: Device: Fixed appliances
Surgically-assisted treatmentExperimentalPatients 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.
Receives: Procedure: Corticotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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

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

Secondary outcomes (2)

  1. Changes in the Gingival Index (GI)

    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.

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

  2. 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.

    1. Bleeding some seconds after probing.
    2. Bleeding immediately after probing.
    3. Bleeding on probing spreading towards the marginal gingiva.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start23 Sep 2018
  3. Primary completion13 Dec 2019
  4. Study completion15 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644678
Sponsor's protocol ID
UDDS-Ortho-15-2022
Status last verified
Dec 2022
First submitted
30 Nov 2022
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23349422

  • 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.

    PubMed 23910198

  • 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.

    PubMed 17257160

  • 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.

    PubMed 10711607

  • 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.

    PubMed 8291494

  • 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.

    PubMed 18251594

Questions about this trial

What is this clinical trial studying?

A study testing Fixed appliances and Corticotomy in people with Impacted Canine, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644678, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.

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