Evaluation of Periodontal Distractor in Acceleration of Canine Retraction
Assessment of Orthodontic Canine Retraction Via Two Approaches of Periodontal Distraction: A Comparative Clinical Study
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedMay 24, 2023
May 1, 2023
6 months
March 7, 2023
May 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
rate of canine retraction
amount of distalization\\time
one month
Secondary Outcomes (1)
pain intensity
one month
Other Outcomes (1)
pulp vitality
two months
Study Arms (2)
periodontal distractor with interseptal bone cuts
EXPERIMENTALperiodontal distractor without interseptal bone cuts
EXPERIMENTALInterventions
custom made device from hyrex screw
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dental Medicine, Al Azhar University
Cairo, Egypt
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer, Deparement of Orthodontics, Al Azhar University
Study Record Dates
First Submitted
March 7, 2023
First Posted
May 24, 2023
Study Start
July 1, 2022
Primary Completion
January 5, 2023
Study Completion
January 30, 2023
Last Updated
May 24, 2023
Record last verified: 2023-05