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Completed

NCT Number: NCT05772975

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

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.

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Key information

Conditions

Platelet-rich Fibrin

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry with Dental Clinical Center

Sarajevo, Federation of Bosnia and Herzegovina, 71000, Bosnia and Herzegovina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H-PRF (Horizontal-platelet rich fibrin)

Biological

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

Biological

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.

Primary outcomes

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

    Time frame: 3 days

    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.

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

    Time frame: 7 days

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

    Time frame: 1 month

    Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.

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

    Time frame: 3 months

    Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.

Secondary outcomes

  1. The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth

    Time frame: 1 month

    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

  2. The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth

    Time frame: 3 months

    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. The impact of E-PRF vs H-PRF vs Control on postoperative trismus

    Time frame: 3 days

    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.

  4. The impact of E-PRF vs H-PRF vs Control on postoperative trismus

    Time frame: 7 days

    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.

  5. The impact of E-PRF vs H-PRF vs Control on postoperative swelling

    Time frame: 3 days

    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).

  6. The impact of E-PRF vs H-PRF vs Control on postoperative swelling

    Time frame: 7 days

    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. The impact of E-PRF vs H-PRF vs Control on postoperative pain

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Amila Haskic

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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