Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth

Platelet-rich Fibrin Clinical Trial

Official title:

Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608356
• Other study ID #: i-prf-en-masse-cu-2022-11-1
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Ahmed Sabrah, Master Degree of Orthodontics
• Phone: +201063688954
• Email: ahmedmagdy25291[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.

Description:

Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.

1. Subject examination to ensure he/she meets the eligibility criteria of the research.

2. Leveling and alignment using fixed orthodontic appliance.

3. Upper first premolars extraction as a part of the orthodontic treatment planning.

4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Orthodontic patients with and age range (16 - 30) years.

2. Protruded upper anterior teeth requiring extraction of first premolars and anterior teeth retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.

3. Patients with full permanent dentition (with the exception of third molars).

4. Healthy dental and periodontal condition with good oral hygiene

Exclusion Criteria:

1. Patients with extensive restorations on the anterior teeth.

2. Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.

3. History of previous orthodontic treatment or trauma to the anterior teeth.

4. Syndromic patients and patients with systemic diseases.

5. Poor oral hygiene or periodontal diseases.

Related Conditions & MeSH terms

• Platelet-rich Fibrin

Intervention

Biological:
• injectable platelet rich fibrin(i-prf)
I-prf is a second-generation PRP where autologous platelets and leukocytes are present in a complex fibrin matrix and can be obtained from blood using low-speed centrifugation without adding anticoagulants.

Drug:
• Sham Injection
Sham injection as a placebo injection

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of En masse retraction	Alginate impression will be taken for each participant to obtain a plaster model obtained at five time points: before incisor retraction (T0), after one month (T1), after two months (T2), after three months(T3), and after four months (T4) of retraction. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research. In both groups, the amount of space closure will be calculated by a digital caliper in millimeters for each time point (T) and averaged for right and left sides.	4 months
Secondary	Associated Pain	Pain will be assessed using a visual analogue scale questionnaire that will be completed by the patient starting from the day following i-prf injection in the intervention group or the sham injection in the control group, the questionnaire will be repeated every month until the fourth month	4 months