Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery

NCT ID: NCT05563519

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Impacted third molar extraction is a very common surgical intervention. Post-procedure pain causes various post-operative changes such as edema and trismus. Minimizing these changes will enable patients to overcome the post-operative process more easily. In this study, it was aimed to compare the possible effects of I-PRF (Impregnated Platelet Rich Fibrin) type 1 collagen with L-PRF (Leukocyte Platelet Rich Fibrin) on postoperative complications and wound healing after lower impacted wisdom tooth surgery. There are studies in the literature showing that very different treatment methods are used for buried twenty-year-old surgery. However, although there are studies in which intra-socket L-PRF, I-PRF, and collagen plugs are applied, there is no accepted standard for comparing the effects of L-PRF and I-PRF impregnated type-1 collagen with each other or for postoperative comfort. The aim of the study is to observe the effect of 2 different techniques on postoperative complications and possible changes in wound healing and discuss whether there is a difference and the effective one.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ACE RCP(Resorbable Collagen Plug), Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey, USA) was impregnated and applied into the socket as such. It was followed for 4 weeks. Both surgical sites were sutured with 4\\0 silk sutures (18mm, 3\\8 sharp, 75cm black suture). It was determined randomly which material would be used first on which side.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impacted Third Molar Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ACE RCP, Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey) USA)) was impregnated and applied into the socket as such. It was followed for 4 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I-PRF + collagen

I-PRF will be applied with type 1 collagen to the extraction socket after the wisdom tooth operation.

Group Type ACTIVE_COMPARATOR

I-PRF with collagen

Intervention Type PROCEDURE

The products will be applied to the sockets after tooth extractions

L-PRF

Only L-PRF will be applied to the extraction socket after the wisdom tooth operation

Group Type ACTIVE_COMPARATOR

L-PRF

Intervention Type PROCEDURE

The products will be applied to the sockets after tooth extractions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I-PRF with collagen

The products will be applied to the sockets after tooth extractions

Intervention Type PROCEDURE

L-PRF

The products will be applied to the sockets after tooth extractions

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals aged 18 years and over,
* Patients with semi-impacted or fully impacted wisdom teeth,
* Patients without systemic disease (According to ASA(The American Society of Anesthesiologists) classification, ASA1 individuals),
* Individuals who did not use any medication in the last two weeks.

Exclusion Criteria

* Individuals with painful temporomandibular joint disease,
* Internal irregularity and/or inflammatory joint disease with a mouth opening of less than 25 mm,
* Pregnant and lactating individuals,
* Individuals who do not come to their postoperative controls,
* Individuals using different drugs other than those recommended,
* Individuals who are allergic to the study drugs and materials.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

levent Cigerim

Head of Oral and Maxillofacial Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Levent Ciğerim, Assoc.Prof.

Role: STUDY_DIRECTOR

Van Yuzuncu Yil University, Faculty of Dentistry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25.12.2020/01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Collagen In Tooth Extraction Procedures
NCT07270510 ACTIVE_NOT_RECRUITING PHASE4