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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Platelet-rich Fibrin
• Intervention / Treatment: Biological: injectable platelet rich fibrin(i-prf); Drug: Sham Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Sabrah, Master Degree of Orthodontics; Phone Number: +201063688954; Email: ahmedmagdy25291@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • Faculty of dentistry cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Intervention group subjects will receive injectable platelet rich fibrin (i-prf) . The (i-prf) will be injected in the periodontal ligament of maxillary anterior teeth during en masse retraction.The injection sites will be the sites of bone compression to target the surfaces of the bone where osteoclastogenesis and bone resorption occurs during en masse retraction. Considering that the obtained (i-prf) after centrifuging would be 4 ml, 1 ml will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. The study group will receive i-PRF intraligamentally in the periodontal ligament space of the maxillary six anterior teeth three times as follow, just before anterior teeth retraction, and after 21 days of the retraction, and after 42 days of the retraction. Before each time of injection, an anesthetic solution will be administered for pain control.	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.
Sham Comparator: control group; Subjects in the control group will only receive sham (placebo) injection three successive times with and interval of 21days between each injection, similar to the timepoints of (i-prf) injection in the intervention group. Also the sites of injection will be similar to the sites of injection of the intervention group; 1 ml of the placebo agent will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. An anesthetic solution will be administered for pain control before the administration of the sham injections.	Drug: Sham Injection; Sham injection as a placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: i-prf-en-masse-cu-2022-11-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No