Efficacy of Biological Technique in Upper Canine Retraction and Levels of Discomfort

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03399422
• Date of registration: 08/01/2018
• Prospective Registration: No
• Primary sponsor: Damascus University
• Public title: Efficacy of Biological Technique in Upper Canine Retraction and Levels of Discomfort
• Scientific title: Evaluation the Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Upper Canine Retraction and the Levels of Acceptance and Discomfort
• Date of first enrolment: August 20, 2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03399422
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Syrian Arab Republic

Contacts

• Name: Rania Haddad, PhD.
• Affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult healthy patients, Male and female, Age range: 15-27 years.

2. Class II Division 1 malocclusion:

Mild / moderate skeletal Class II (ANB =7) Overjet =10 Normal or excessive facial
height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y
axis) Mild to moderate crowding = 4

3. permanent occlusion.

4. Exist all the upper teeth (except third molars).

5. Good oral and periodontal health:

Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index = 1 Plaque index
= 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)

2. patients have anti indication for oral surgery ( medical - social - psycho)

3. Presence of primary teeth in the maxillary arch

4. Missing permanent maxillary teeth (except third molars).

5. Poor oral hygiene or Current periodontal disease:

Probing depth = 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque
index > 1

6. Patient had previous orthodontic treatment

7. Craniofacial anomalies (cleft lip and palate patients)

8. Smokers

9. coagulation disorders and patients treated with anticoagulants.

10. patients with immunodeficiency disorders



Age minimum: 15 Years
Age maximum: 27 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malocclusion, Angle Class II, Division 1

Intervention(s)

Biological: i-PRF

Procedure: canine retraction

Primary Outcome(s)

Change of the rate of canine retraction [Time Frame: Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction]

Secondary Outcome(s)

pain levels [Time Frame: on the first day after an hour, 2 hours and 6 hours of PRF injection]

Secondary ID(s)

UDDS-Ortho-02-2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors