Clinical trial

Evaluation of Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Surgery With the Use of E-PRF and H-PRF - a Randomized Controlled Clinical Study

Name

02-3-4-59-1-3/2021

Description

This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are: Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.

Trial arms

Trial start

2023-04-01

Estimated PCD

2023-12-01

Trial end

2024-05-01

Status

Recruiting

Phase

Early phase I

Treatment

H-PRF (Horizontal-platelet rich fibrin)

Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. it serves as a biological healing matrix by supporting cell migration and cytokine release. H-PRF is obtained by horizontal centrifugation using (Bio-PRF) centrifuge on 700 g force for 8 minutes. This way the cells separate much more efficiently throughout the entire membrane/clot.

Arms:

H-PRF

E-PRF

Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. In order to extend its resorption period heating method is used. After centrifugation of blood using (Bio-PRF) centrifuge on 700 g force for 8 minutes top layer is heated for 10 minutes at 75°C in BIO-Heat device. When cooled it is mixed with cell rich buffy coat. This way PRF with extended life is obtained.

Arms:

E-PRF

Size

100

Primary endpoint

The impact of E-PRF vs H-PRF vs Control on soft tissue healing

3 days

The impact of E-PRF vs H-PRF vs Control on soft tissue healing

7 days

The impact of E-PRF vs H-PRF vs Control on bone regeneration

1 month

The impact of E-PRF vs H-PRF vs Control on bone regeneration

3 months

Eligibility criteria

Inclusion Criteria: * Orthodontic indication for impacted mandibular third molar surgery * Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA) Exclusion Criteria: * Presence of systemic disease * Presence of a condition that affects fibrin clot formation * History of radiation therapy or chemotherapy * Allergy to penicillin * Oral contraceptive usage * Smoking habit * Status of pregnancy or lactation * Presence of any acute local infection * Missing the adjacent second molar or indicated for extraction

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-03-17

1 organization

2 products

1 indication

Organization

Product

Indication

Product