Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction

NCT ID: NCT06609967

Last Updated: 2024-09-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-08-30

Brief Summary

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

As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively

Detailed Description

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

PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction

Conditions

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

Pain, Postoperative Post Operative Swelling Trismus Soft Tissue Healing

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

PRF group

Group Type EXPERIMENTAL

application of PRF

Intervention Type PROCEDURE

PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7

Non-PRF group

Group Type ACTIVE_COMPARATOR

application of conventional surgicel

Intervention Type PROCEDURE

it will be a control group in which extraction sockets will be left to heal with the natural blood clot.

Interventions

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

application of PRF

PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7

Intervention Type PROCEDURE

application of conventional surgicel

it will be a control group in which extraction sockets will be left to heal with the natural blood clot.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

1. Both male and female patients
2. Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
3. Patients with 3rd molar impactions
4. Absence of systemic diseases
5. age ⩾18 years and the ability to cooperate with the requirements of the study protocol.

Exclusion Criteria

1. Medically compromised patients.
2. Immunocompromised patients.
3. Patients that do not consent.
4. Patients that are below the age of 17.
5. Patients that are pregnant.
6. Fully erupted molars will be excluded. smokers (\> 5 a day) will be excluded as well.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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

Hamza Jawed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status

Countries

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

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

Passarelli PC, Romeo A, Lopez MA, De Angelis P, Desantis V, Piccirillo GB, Papa R, Papi P, Pompa G, Moffa A, Casale M, D'Addona A. Evaluation of the periodontal healing of the second mandibular molar distal site following insertion of PRF in the third molar post extraction alveolus. J Biol Regul Homeost Agents. 2020 Sep-Oct;34(5 Suppl. 3):111-118. Technology in Medicine.

Reference Type BACKGROUND
PMID: 33386040 (View on PubMed)

Other Identifiers

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

Hamza001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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