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Evaluation of Periodontal Distractor in Acceleration of Canine Retraction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05872048
Enrollment
16
Registered
2023-05-24
Start date
2022-07-01
Completion date
2023-01-30
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Canine Retraction

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.

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.

Interventions

custom made device from hyrex screw

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 21 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
rate of canine retractionone monthamount of distalization\\time

Secondary

MeasureTime frameDescription
pain intensityone monthvisual analog scale minimum score = 0 maximum score = 10 higher scores mean worse outcome

Other

MeasureTime frameDescription
pulp vitalitytwo monthselectric pulp tester

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026