Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05772975
Other study ID # 02-3-4-59-1-3/2021
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06420713 - Horizontal Bone Augmentation of Alveolar Ridge N/A
Withdrawn NCT03715439 - Evaluation of Dental Implants Placed in Preserved and Non-preserved Post-extraction Ridges
Recruiting NCT06440655 - The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients N/A
Recruiting NCT06190860 - Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers N/A
Completed NCT05957705 - Maxillary Sinus Augmentation With Xenogeneic Bone Graft Associated or Not With Fibrin Rich in Platelets and Leukocytes Produced by Horizontal Centrifugation: A Randomized Clinical Trial. N/A
Completed NCT05264467 - Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis Phase 2/Phase 3
Not yet recruiting NCT06044246 - Influence of Human Platelet Derivatives on Dental Implant N/A
Active, not recruiting NCT06200727 - Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases N/A
Completed NCT05753631 - Effects of i-PRF on Non-surgical Periodontal Treatment
Recruiting NCT05608356 - Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth N/A
Completed NCT05866965 - Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery N/A
Completed NCT05008068 - Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes Phase 1
Recruiting NCT05766618 - The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction Phase 3
Completed NCT05409495 - Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration N/A