Effect of Injectable Platelet Rich Fibrin (i-PRF) on Extraction Socket Healing: A Split-Mouth Randomized Study.

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-07-31

Brief Summary

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The aim of this study is to compare extraction socket healing (SH) following surgical extraction of lower third molars (LTMs) with and without the application of injectable platelet rich fibrine (i-PRF). A minimum of 32 participants will be included. One mandibular third molar per participant will be randomly assigned to the control group and the contralateral tooth to the test group. SH, gingival recession, and distal periodontal pocket depth of the adjacent second molar will be assessed, and outcomes compared between sides.

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Detailed Description

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Surgical extraction of lower third molars (LTMs) is the most commonly performed procedure in oral and maxillofacial surgery (OMFS). Healing of the extraction socket is a key outcome in oral surgery, as complications in healing may lead to delayed recovery, persistent pain, infection, and adverse events such as dry socket. The aim of this study is to compare extraction socket healing (SH) following surgical extraction of LTMs with and without the application of injectable platelet rich fibrine (i-PRF). For this purpose minimum 32 participants from both sexes will be included to the study. For each participant, one LTM (right or left) will be randomly assigned to the control group and the contralateral tooth to the test group. In the control group, the extraction socket will be irrigated with 0.9% physiological saline solution following standard extraction, whereas in the test group, the socket will be irrigated with i-PRF. SH will be assessed on postoperative days 3 and 14, and at 6 weeks, using the Inflammatory Proliferative Remodeling (IPR) scale and the hydrogen peroxide (H₂O₂) test. Gingival recession and the depth of the periodontal pocket at the distal aspect of the adjacent second molar will be recorded on postoperative days 7 and 14. The outcomes will be compared between the two sides with respect to wound healing.

Conditions

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Wound Healing Tooth Extraction Site Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

To reduce inter-individual variability and minimize bias in estimating the treatment effect, the study was designed as a split-mouth trial, with the two treatments randomly assigned to either the right or left side of the dentition.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The investigators who performed clinical measurements were not involved in the operation and were blinded as to which treatment group the tooth was assigned.

Study Groups

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Control group

In the control group, routine surgical extraction will be performed, and the extraction socket will be irrigated with 0.9% physiological saline.

Group Type PLACEBO_COMPARATOR

Surgical extraction of lower third molars.

Intervention Type PROCEDURE

Surgical extraction of lower third molars: Impacted or difficult-to-remove lower wisdom teeth are removed using surgical techniques, involving an incision in the soft tissue and removal of bone.

Test group

In the test group, routine surgical extraction will be performed, and the extraction socket will be irrigated with i-PRF.

Group Type EXPERIMENTAL

Surgical extraction of lower third molars.

Intervention Type PROCEDURE

Surgical extraction of lower third molars: Impacted or difficult-to-remove lower wisdom teeth are removed using surgical techniques, involving an incision in the soft tissue and removal of bone.

Interventions

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Surgical extraction of lower third molars.

Surgical extraction of lower third molars: Impacted or difficult-to-remove lower wisdom teeth are removed using surgical techniques, involving an incision in the soft tissue and removal of bone.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Individuals of both sexes Age over 18 years Non-smokers Systemically healthy (ASA I) Requiring surgical extraction of bilateral mandibular third molars