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

Not Applicable

Completed

• Conditions: Alveolar Osteitis; Impacted Tooth
• Interventions: Procedure: Non-Concentrated Growth Factor (Control group); Procedure: Concentrated Growth Factor (Test group)

• Registration Number: NCT04151147
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-07-15
• Study Completion: 2018-07-30
• Study First Submitted: 2019-10-30
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-CGF application in the extraction socket	Non-Concentrated Growth Factor (Control group)	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.
CGF application in the extraction socket	Concentrated Growth Factor (Test group)	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.

Primary Outcome Measures

Name	Time	Method
Presence of alveolar osteitis formation	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Bornova, Turkey