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Completed

NCT Number: NCT05872048

Evaluation of Periodontal Distractor in Acceleration of Canine Retraction

evaluate the effect of periodontal distractor with and without interseptal bone cuts on the displacement of the maxillary canines, to assess the effect of two approaches on the pain intensity and on the pulp vitality of the retracted canines.

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Key information

Conditions

Age range

16 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Al Azhar University

Cairo, Egypt

About this study

The sample of the study consisted of 32 canines in 16 female patients (16- 21 years old) requiring extraction of bilateral maxillary first premolars and canine retraction. They were divided into two groups: canine retraction was done by buccal periodontal distractor with distal interseptal bone cuts (Group I), canine retraction was done by buccal periodontal distractor without distal interseptal bone cuts (Group II). After bilateral maxillary premolar extraction in both groups inter septal bone cuts was done in group I only. Then the periodontal distractor was cemented and activated twice per day in both groups. Rate of canine retraction was evaluated before and after complete canine retraction direct in patient's mouth with digital caliper. Pain intensity was evaluated at 1st ,2nd ,4th and 7th days after activation through visual analog scale (VAS). An electrical vitality test was evaluated before and after the distraction procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient age: 16-21 years.
  • patients required bilateral extraction of maxillary first premolars followed by maxillary canine retraction (class I malocclusion as excessive overjet, bimaxillary protrusion, class II malocclusion).
  • The dentition didn't exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
  • No systemic disease that may affects the bone.
  • No periodontal disease.
  • Good oral hygiene.
  • Very good patient compliance.
  • Absence of any previous orthodontic treatment.

Exclusion criteria

  • The dentition exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
  • Cases with deep carious lesions or endodontic lesions involving the maxillary canines and buccal segments.
  • Cases with severly rotated or grossly malpositioned canines.
  • Systemic disease that may affects the bone.
  • Periodontal disease and poor oral hygiene.
  • Presence of previous orthodontic treatment.

Treatment and study plan

periodontal distractor

Device

custom made device from hyrex screw

Primary outcomes

  1. rate of canine retraction

    Time frame: one month

    amount of distalization\\time

Secondary outcomes

  1. pain intensity

    Time frame: one month

    visual analog scale minimum score = 0 maximum score = 10 higher scores mean worse outcome

Other outcomes

  1. pulp vitality

    Time frame: two months

    electric pulp tester

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Assessment of Orthodontic Canine Retraction Via Two Approaches of Periodontal Distraction: A Comparative Clinical Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
May 24, 2023

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.

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