Evaluation of Periodontal Distractor in Acceleration of Canine Retraction

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

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.

Study Overview

• Status: Completed
• Conditions: Canine Retraction
• Intervention / Treatment: Device: periodontal distractor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dental Medicine, Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontal distractor with interseptal bone cuts	Device: periodontal distractor; custom made device from hyrex screw
Experimental: periodontal distractor without interseptal bone cuts	Device: periodontal distractor; custom made device from hyrex screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of canine retraction	amount of distalization\time	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	visual analog scale minimum score = 0 maximum score = 10 higher scores mean worse outcome	one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulp vitality	electric pulp tester	two months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Maha M Mohamed, assistant professor, Assistant professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo; Study Chair: Farouk A Hussein, Professor, professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo; Study Chair: Suzan A Hssan, professor, professor of oral sugery, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: distraction in orthodontics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No