The Use of Injectable-Platelet Rich Fibrin (i-PRF) in the Lower Third Molar Extraction

Not Applicable

Active, not recruiting

• Conditions: Molar, Third; Postoperative Complications
• Interventions: Procedure: Extraction of mandibular third molar; Device: i-PRF

• Registration Number: NCT06073535
• Lead Sponsor: University of Naples

Brief Summary

Lower third molar extraction is one of the most frequently performed surgical procedures in dentistry. Common sequelae, including pain, swelling and trismus, can severely affect patients' quality of life during the immediate postoperative period.

The aim of this randomized-controlled trial is to clinically evaluate the reduction of lower third molar extraction-related complications, such as swelling and pain, and wound healing, following submucosal infiltration of injectable platelet rich fibrin.

Detailed Description

Forty young patients with a partially or totally impacted lower third molar, with an equivalent degree of difficulty, will be selected. All patients will be randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 20 cases: in the first group, the extraction socket will be left healing spontaneously, while in the other side the socket will be filled with i-PRF.

This study was designed as a double-blind research since the investigator will be unaware of their treatment allocation before surgery, and one clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform clinical measurement of the outcomes on the surgery day, 3th and 7th days after surgery.

A software will be used to produce a random sequence of 20 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated to group 1 or group 2.

Prior to surgery, photographic documentation consisting of frontal extraoral photograph, extraoral latero-lateral photograph of the surgery site, extraoral latero-lateral photograph of the opposite site will be performed.

The swelling will be measured summing two linear measurements of distance between Tragus and Pogonion and then Gonion and Commissura labialis points.

Immediately after surgery, the surgeon opens the envelope containing the information about the patient's group membership. In case of i-PRF group, 20 mL will be prepared.

Everyday after surgery, each patients will compile the visual analogic scale to evaluate the pain score.

On 3th and 7th day after surgery, linear measurements of swelling will be taken. Then, on 3th, 7th, 14th, 28th days the wound healing index by Landry will be evaluate.

The Student t test will be used to compare the differences between the two analysed groups. Potential differences between pain, swelling and wound healing based on gender, age and time of surgery will be assessed by using Student's t-test and one-way analysis of variance (ANOVA).

Study Timeline

• Study Start: 2023-02-27
• Primary Completion: 2023-09-04
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21
• Study Completion: 2023-12-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Need for extraction of totally or partially impacted lower third molar
• Equivalent degree of difficulty of lower third molar extraction
• Patients able to understand and sign informed consent

Exclusion Criteria

• General contra-indications for surgery (systemic disease, compromised immune system etc);
• Tobacco smoking
• Alcohol and drug abuse
• Pregnancy and breastfeeding
• Patients taking any medications which might interfere with healing
• Dysplastic processes in the affected tooth elements
• Non-cooperative patients

EXCLUSION CRITERIA DURING FOLLOW-UP - Patients who do not adhere throughout the duration of follow-up to the specialist visits

POSTOPERATIVE EXCLUSION CRITERIA

• Taking more than two doses of prescribed anti-inflammatory/analgesic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
i-PRF	i-PRF	i-PRF will be used after the extraction of the third molar to reduce postoperative complications (swelling, pain) and wound healing.
Spontaneous healing	Extraction of mandibular third molar	After the extraction of the lower third molar the socket will be left to heal spontaneously.
i-PRF	Extraction of mandibular third molar	i-PRF will be used after the extraction of the third molar to reduce postoperative complications (swelling, pain) and wound healing.

Primary Outcome Measures

Name	Time	Method
Postoperative swelling	Measurements will be taken before surgery, on day 3 and day 7.	Measurements will be made with a flexible ruler taking as reference the diagonals joining Tragus and Pogonion; Gonion and Labial Commissura. Swelling will be calculated as the sum of these diagonals.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	Everyday after surgery until 7th day.	Pain was assessed with a visual analogic scale (VAS) from 0 (absence of pain) to 10 (severe pain).

Trial Locations

Locations (1)

Gilberto Sammartino; 🇮🇹 Naples, Italy