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

NCT04151147 | Completed

• 1 other identifier: Oral Surgery
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Osteitis; Impacted Tooth

Keywords

Third molar surgery; Alveolar osteitis; Platelet concentrates

Outcome Measures

Primary Outcomes (1)

• 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.

  Change of alveolar osteitis formation at 7 days.

Study Arms (2)

CGF application in the extraction socket

EXPERIMENTAL

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.

Procedure: Concentrated Growth Factor (Test group)

non-CGF application in the extraction socket

EXPERIMENTAL

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.

Procedure: Non-Concentrated Growth Factor (Control group)

Interventions

Concentrated Growth Factor (Test group) PROCEDURE

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.

CGF application in the extraction socket

Non-Concentrated Growth Factor (Control group) PROCEDURE

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.

non-CGF application in the extraction socket

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35050, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32807173 DERIVED

MeSH Terms

Conditions

Dry Socket; Tooth, Impacted

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Banu Özveri Koyuncu

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: January 2, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 30, 2018
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)