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

NCT05608356 | Unknown

• 1 other identifier: i-prf-en-masse-cu-2022-11-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet-rich Fibrin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Associated Pain

  4 months

Study Arms (2)

intervention group

EXPERIMENTAL

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)

control group

SHAM COMPARATOR

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

Interventions

injectable platelet rich fibrin(i-prf) BIOLOGICAL

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.

intervention group

Sham Injection DRUG

Sham injection as a placebo injection

control group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Orthodontic patients with and age range (16 - 30) years.
• 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.
• Patients with full permanent dentition (with the exception of third molars).
• Healthy dental and periodontal condition with good oral hygiene

You may not qualify if:

• Patients with extensive restorations on the anterior teeth.
• Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
• History of previous orthodontic treatment or trauma to the anterior teeth.
• Syndromic patients and patients with systemic diseases.
• Poor oral hygiene or periodontal diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Ahmed Sabrah, Master Degree of Orthodontics

CONTACT

+201063688954; ahmedmagdy25291@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data assessment will be blinded as an assessor not participating in the study will be responsible for measuring the rate of en masse retraction, as the patient name could be hidden during data analysis. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: interventional group will receive injectable platelet rich fibrin intraligamentally distal to the right and left canines, and palatal to the upper 4 incisors, in three time points with 21 days interval, control group will receive sham injection instead.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: December 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)