Effect of CGF on Short Term Clinical Outcomes After Partially Impacted Mandibular Third Molar Surgery

NCT03913884 | Completed

• 1 other identifier: Faculty of Dentistry
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effectiveness of concentrated growth factor (CGF) on soft tissue healing and postoperative side effects following third molar surgery. This study was designed on 60 patients as a randomized single-blind clinical trial. The predictor variable was the implementation of CGF fibrin matrix, which was categorized as CGF and non-CGF. The primary outcome variable of the study was the healing of soft tissue around the extraction socket. The secondary outcome variables were pain, swelling and trismus. Data were analyzed using the non-parametric Brunner and Langer model. Statistical significance was set at P \< .001.

Conditions

Postoperative Pain; Trismus; Edema

Keywords

Impacted third molar surgery; Clinical outcomes; Concentrated growth factor

Outcome Measures

Primary Outcomes (1)

• soft tissue healing

  This was assessed on the third and seventh preoperative days using the healing index classified by Landry et al.12. It depends on tissue colour, presence of bleeding on palpation, epithelization of wound margins, granulation tissue and suppuration, and rates the degree of healing attained from 'very poor' to 'excellent'.

  Change of soft tissue healing at 7 days

Secondary Outcomes (3)

• severity of postoperative pain

  Change of postoperative pain at 7 days

• presence of swelling

  Change of swelling at 7 days

• presence of trismus

  Change of trismus at 7 days

Study Arms (2)

Concentrated growth factor Group

EXPERIMENTAL

Group I (test); in which CGF fibrin matrix was applied to the extraction socket

Procedure: Concentrated growth factor

Non-Concentrated growth factor Group

EXPERIMENTAL

Group II (control); in which CGF was not applied to the extraction socket

Other: Non-Concentrated growth factor Group

Interventions

Concentrated growth factor PROCEDURE

CGF fibrin matrix was placed in one socket which was randomly selected (test side). The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.

Concentrated growth factor Group

Non-Concentrated growth factor Group OTHER

To control group, extraction of the tooth on the opposite site was performed and the socket left to heal naturally. The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.

Non-Concentrated growth factor Group

Eligibility Criteria

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

You may qualify if:

• Bilateral, vertically, partially-impacted Class I, Level B third molars

You may not qualify if:

• Infection of the surgical region
• Smoking habit
• Alcohol usage
• Physical or mental disability
• Thrombocytopenia
• Chemotherapy in head and neck region
• Pregnant woman or woman in menstrual cycle

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (1)

• Ozveri Koyuncu B, Isik G, Ozden Yuce M, Gunbay S, Gunbay T. Effect of concentrated growth factor (CGF) on short-term clinical outcomes after partially impacted mandibular third molar surgery: A split-mouth randomized clinical study. J Stomatol Oral Maxillofac Surg. 2020 Apr;121(2):118-123. doi: 10.1016/j.jormas.2019.07.002. Epub 2019 Jul 9.

  PMID: 31299343 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Edema

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Gözde Işık

  Oral Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral Surgery

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: April 4, 2018
• Primary Completion: August 19, 2018
• Study Completion: August 26, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)