Distractor Effect on Pain and Vitality

NCT05814185 | Completed

• 1 other identifier: PDL distractor
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the effect of two and four activations /day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.

Conditions

Distraction of Bone

Outcome Measures

Primary Outcomes (4)

• pain intensity

  evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10.

  1st 48 hour after intervention (from the time of distractor placement until the end of the 2nd day)

• pain intensity

  evaluation of pain intensity by Visual Analogue scale.minimum 0 and maximum value 10

  during each activation of the distractor,(up to 1 minute during moving the key of distractor)

• pain intensity

  evaluation of pain intensity by Visual Analogue scale. minimum 0 and maximum value 10

  up to 6 hours on the four activations group and up to 12 hours on two activations group.

• pulp vitality

  vitality by Electric pulp tester.positive reading is better

  before and after canine retraction (up to one month)

Study Arms (2)

Canine retraction was done by periodontal distractor with two activations per day.

EXPERIMENTAL

group 1

Device: Periodontal distractor

Canine retraction was done by periodontal distractor with four activations per day.

EXPERIMENTAL

group 2

Device: Periodontal distractor

Interventions

Periodontal distractor DEVICE

different activation protocols of periodontal distractor

Canine retraction was done by periodontal distractor with four activations per day.; Canine retraction was done by periodontal distractor with two activations per day.

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Orthodontic Patients need extraction of first permanent premolar for orthodontic reasons (dentoalveolar maxillary protrusion, Class II div 1 malocclusion)
• No history of previous orthodontic treatment
• Absence of any systemic disease
• Good oral hygiene and healthy gums look, with no signs of redness, edema, or bleeding during brushing (periodontal inflammation)
• Highly motivation and cooperation

You may not qualify if:

• Medically compromised patients
• Use of medication that may affect tooth movement during the period of the study

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, for Girls, Al Azhar University

Cairo, Nasr City, 02, Egypt

Location

MeSH Terms

Conditions

Diastasis, Bone

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Alaa M. Eldriny, Lecturer

  Assistant Lecturer of Orthodontics,Al Azhar University, Cairo, Egypt.

  PRINCIPAL INVESTIGATOR

• Ahmed A. Salama, professor

  Professor of Orthodontics, Al Azhar University, Cairo, Egypt.

  STUDY DIRECTOR

• Osama S. El-Shal, professor

  Professor of periodontology Al Azhar University, Cairo, Egypt.

  STUDY DIRECTOR

• Maha M. Mohamed, professor

  Assistant professor of Orthodontics, Al Azhar University, Cairo, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of orthodontics

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 14, 2023
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 15, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

EG (1)