Effect of CGF on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery

November 1, 2019 updated by: Gözde Işık, Ege University

Effect of Concentrated Growth Factors on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Study

The aim of this prospective study was to assess the effectiveness of concentrated growth factors (CGFs) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars.

This study was designed as a randomized controlled clinical trial. In each case, one socket received CGFs and the other served as a control. The predictor variable was the CGFs application and the sides were categorized as 'CGFs' and 'non-CGFs'. The outcome variable was the development of AO during the first postoperative week. Also, demographic variable included age and gender was noted.

Study Overview

Detailed Description

The investigators designed and implemented a randomized single-blind clinical trial.Randomization was performed by simple coin toss to select the side of CGFs fibrin gel placement before the commencement of third molar surgery. In this way, the sides in each patient were randomly divided into 2 study groups:

Group I (test) - with CGFs placed in the extraction socket Group II (control) - without CGFs placement All operations were performed under local anesthesia by the same surgeon. An envelope flap was raised to provide access. Bone removal was done with the help of stainless steel burs. Constant irrigation with saline was used while removing bone to prevent thermal necrosis. Third molar was luxated with the help of straight elevator and then extracted with the help of third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. To prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. CGFs fibrin gel was then randomly placed into one socket and the opposite side was considered as the control. Finally, wound closure was completed with silk suture.

The primary outcome variable was AO, classified as present or absent.It is characterized by postoperative pain in and around the extraction side, which increases in severity within first week after the extraction, accompanied by a partially or totally disintegrated blood clot within the alveolar socket, with or without halitosis. Other defining symptoms that have been reported in the literature are radiating pain towards the temporal region and ear, inflamed gingival margin, ipsilateral regional lymphadenopathy and, less commonly, low-grade fever.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bornova
      • İzmir, Bornova, Turkey, 35050
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients Age ≥ 18 years of age
  • Willing and able to provide informed consent
  • Ability to cooperate with the requirements of the study protocol
  • Healthy patients without medical diseases or a history of bleeding problems
  • Patients with the need of extraction of third molars
  • The third molars had to be symmetrical, partially-erupted and in the Class I, Level B according to Pell & Gregory classification and in the vertical angulations according to Winter's classification.

Exclusion Criteria:

  • Patients who have pre-existing abscess or cellulitis, acute pericoronitis, or pre-existing conditions such as an odontogenic cyst or tumour associated with their third molars
  • Patients who were pregnant and breastfeeding
  • Patients with drug usage such as bisphosphonate, steroids and antidepressants
  • Patients who had a smoking habit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CGF application in the extraction socket
Partially impacted third molar was extracted with the help of straight elevator and third molar forceps. After extraction, any remains of the dental follicle were removed and the extraction sockets were irrigated with 60 mL of sterile saline. CGF fibrin gel was then randomly placed into one socket and wound closure was completed with silk suture.
The patients' blood was collected in 9 ml glass tubes and immediately centrifuged to prevent coagulation in special centrifuge device. The CGF program was set up as follows: accelerated for 30 seconds so as to reach 2700 rpm, rotated for 2 minutes, then reduced to 2400 rpm, then rotated again for 4 minutes and accelerated to 2700 rpm, rotated for 4 minutes, then accelerated to 3000 rpm for 3 minutes, and decelerated for 36 seconds to stop. The middle layer in the tube was separated by the ''Buffy coat'' containing the CGFs fibrin gel using forceps and scissor. Then, this fibrin gel was inserted in the extraction cavity.
EXPERIMENTAL: non-CGF application in the extraction socket
Opposite side of the patient was considered as the control. After extraction of the third molar, dental follicle were removed and to prevent the flap laceration, bone contouring was also performed under sterile saline irrigation. Finally, wound closure was completed with silk suture.
Third molar extraction was performed under local anesthesia. Following the extraction, the socket was sutured and natural healing process was observed. This side was considered as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of alveolar osteitis formation
Time Frame: Change of alveolar osteitis formation at 7 days.
Clinical data was collected with regard to alveolar osteitis formation on the 3rd and 7th days after surgery with the following characteristics: 1) progressive and severe pain in and around the extraction side within first week; 2) partially or totally loss of blood clot and exposure of the alveolar bone with or without halitosis. Patients who met one of the criterias, were taken to be alveolar osteitis.
Change of alveolar osteitis formation at 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Banu Özveri Koyuncu, Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2018

Primary Completion (ACTUAL)

July 15, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (ACTUAL)

November 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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