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Impact of Advanced Platelet Rich Fibrin and Enamel Matrix Derivative on Clinical and Molecular Wound Healing Parameters After Surgical Removal of Mandibular Third Molars

NCT06190015 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-01-05

No results posted yet for this study

Summary

Brief summary

The goal of this study is to compare the effects of advanced platelet rich fibrin and enamel matrix derivative placed in the extraction alveoli of patients who had surgical removal of mandibular wisdom teeth. The questions it aims to answer/evaluate are:

* postoperative pain, swelling, trismus, early wound healing using soft tissue healing index
* level of early local inflammatory response by measuring levels of inflammatory mediators in wound exudate
* degree of wound healing by measuring levels of early wound healing mediators in wound exudate
* incidence of alveolar osteitis and delayed infection
* levels of probing depth, clinical attachment loss, gingival margin level, bleeding on probing, gingival index, plaque index of the second mandibular molar 3 months after surgery

Participants of the study will be asked:

* for their preoperative clinical measurements (swelling, trismus, periodontal parameters) to be taken by the principal investigator
* to provide 20 ml of venous blood if necessary
* to preoperatively provide gingival crevicular fluid in the region of distal surface of the second mandibular molar and postoperatively wound exudate
* to note the number of painkiller pills taken after surgery and pain levels in different time points
* to come to regular checkups in which clinical measuring of postoperative swelling, trismus levels and periodontal parameters will be performed

Conditions

  • Surgical Wound, Healed
  • Post Operative Pain

Interventions

BIOLOGICAL

Advanced platelet rich fibrin (APRF) clots

15 minutes before surgery, phlebotomy will be performed and two vacutainers containing 10ml of blood will be placed in the centrifuge for 8 min and 200g. Acquired APRF clots will be placed in the extraction alveolus

DEVICE

Enamel matrix derivative (EMD) group

After third molar removal, Pref Gel (EDTA) will be placed on the root surface for 2 min and then removed. Emdogain (EMD) will be placed on the collagen sponge (Botiss, Collacone) and then applied in the wound so that the side of the sponge which is covered with Emdogain is in contact with the root surface.

Sponsors & Collaborators

  • University of Belgrade

    lead OTHER

Principal Investigators

  • Snjezana Colic, professor of oral surgery · School of dental medicine, University of Belgrade, Serbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2024-01-20
Completion
2024-03-20

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190015 on ClinicalTrials.gov