The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery

Platelet-Rich Fibrin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772975
• Other study ID #: 02-3-4-59-1-3/2021
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: University of Sarajevo
• Contact: Amila Haskic
• Phone: +38761923863
• Email: am.colakhodzic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.

The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.

All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Platelet-Rich Fibrin

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Bosnia and Herzegovina	Faculty of Dentistry with Dental Clinical Center	Sarajevo	Federation Of Bosnia And Herzegovina

Sponsors (1)

Lead Sponsor	Collaborator
Amila Haskic

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of E-PRF vs H-PRF vs Control on soft tissue healing	Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.	3 days
Primary	The impact of E-PRF vs H-PRF vs Control on soft tissue healing	Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.	7 days
Primary	The impact of E-PRF vs H-PRF vs Control on bone regeneration	Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.	1 month
Primary	The impact of E-PRF vs H-PRF vs Control on bone regeneration	Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.	3 months
Secondary	The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth	Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual- by a single evaluator. Periodontal pocket depth will be measured preoperatively, one month and three months postoperatively	1 month
Secondary	The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth	Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual.	3 months
Secondary	The impact of E-PRF vs H-PRF vs Control on postoperative trismus	The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.	3 days
Secondary	The impact of E-PRF vs H-PRF vs Control on postoperative trismus	The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.	7 days
Secondary	The impact of E-PRF vs H-PRF vs Control on postoperative swelling	The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).	3 days
Secondary	The impact of E-PRF vs H-PRF vs Control on postoperative swelling	The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).	7 days
Secondary	The impact of E-PRF vs H-PRF vs Control on postoperative pain	The primary outcome is to asses the level of pain after mandibular third molar surgery in study groups vs control. A visual analog scale (VAS) will be used to evaluate postoperative pain. A 10-point VAS with a score of 0 equals "no pain" and 10 equals "very severe pain" will be used to asses subjective pain. Patients will be asked to record number of analgesic taken during the monitoring period of 7days.	7 days