Clinical trial NCT05872048: Evaluation of Periodontal Distractor in Acceleration of Canine Retraction
Official title: Assessment of Orthodontic Canine Retraction Via Two Approaches of Periodontal Distraction: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Canine Retraction
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rate of canine retraction
timeFrame: one month
Secondary outcomes:
measure: pain intensity
timeFrame: one month
Other outcomes:
measure: pulp vitality
timeFrame: two months
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine, Al Azhar University
Study officials:
affiliation: Assistant professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
name: Maha M Mohamed, assistant professor
role: STUDY_DIRECTOR
affiliation: professor of orthodontics, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
name: Farouk A Hussein, Professor
role: STUDY_CHAIR
affiliation: professor of oral sugery, Faculty of Dental Medicine, Al Azhar Univeristy, Cairo
name: Suzan A Hssan, professor
role: STUDY_CHAIR
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