Clinical trial NCT05772975: The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platelet-Rich Fibrin
Keywords: Molar, Third
PRF
Platelet-Rich Fibrin
Lead sponsor: University of Sarajevo
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 61
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: The impact of E-PRF vs H-PRF vs Control on soft tissue healing
timeFrame: 3 days
measure: The impact of E-PRF vs H-PRF vs Control on soft tissue healing
timeFrame: 7 days
measure: The impact of E-PRF vs H-PRF vs Control on bone regeneration
timeFrame: 1 month
measure: The impact of E-PRF vs H-PRF vs Control on bone regeneration
timeFrame: 3 months
Secondary outcomes:
measure: The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
timeFrame: 1 month
measure: The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
timeFrame: 3 months
measure: The impact of E-PRF vs H-PRF vs Control on postoperative trismus
timeFrame: 3 days
measure: The impact of E-PRF vs H-PRF vs Control on postoperative trismus
timeFrame: 7 days
measure: The impact of E-PRF vs H-PRF vs Control on postoperative swelling
timeFrame: 3 days
measure: The impact of E-PRF vs H-PRF vs Control on postoperative swelling
timeFrame: 7 days
measure: The impact of E-PRF vs H-PRF vs Control on postoperative pain
timeFrame: 7 days
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Faculty of Dentistry with Dental Clinical Center
state: Federation Of Bosnia And Herzegovina
Study officials:
affiliation: University of Sarajevo
name: Amila Haskic
role: PRINCIPAL_INVESTIGATOR
References: