search
Back to results

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

Primary Purpose

Alveolar Osteitis, Impacted Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Concentrated Growth Factor (Test group)
Non-Concentrated Growth Factor (Control group)
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Osteitis focused on measuring Third molar surgery, Alveolar osteitis, Platelet concentrates

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CGF application in the extraction socket

non-CGF application in the extraction socket

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of alveolar osteitis formation
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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2019
Last Updated
November 1, 2019
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT04151147
Brief Title
Effect of CGF on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery
Official Title
Effect of Concentrated Growth Factors on Frequency of Alveolar Osteitis Following Partially Erupted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis, Impacted Tooth
Keywords
Third molar surgery, Alveolar osteitis, Platelet concentrates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGF application in the extraction socket
Arm Type
Experimental
Arm Description
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.
Arm Title
non-CGF application in the extraction socket
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Concentrated Growth Factor (Test group)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-Concentrated Growth Factor (Control group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of alveolar osteitis formation
Description
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.
Time Frame
Change of alveolar osteitis formation at 7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Özveri Koyuncu
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32807173
Citation
Ozveri Koyuncu B, Isik G, Ozden Yuce M, Gunbay S, Gunbay T. Effect of concentrated growth factors on frequency of alveolar Osteitis following partially-erupted mandibular third molar surgery: a randomized controlled clinical study. BMC Oral Health. 2020 Aug 17;20(1):222. doi: 10.1186/s12903-020-01210-7.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs