NCT06918327

Brief Summary

The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on pain after bilateral impacted third molar surgery and to determine its contribution to the healing process. The main question it aims to answer is: Is CGF effective on reducing the pain in impacted third molar surgery? Researchers compare the pain on the CGF-applied and CGF free sides after impacted third molar surgery. Postoperative pain is assessed using the Visual Analogue Scale. TThe postoperative outcomes including pain are clinically assessed at different-time intervals (1-7 days).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

April 20, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 31, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

PainThird molarVAS scale

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain on CGF-applied and CGF free sides in bilateral impacted third molar surgery

    The primary outcome measure is postoperative pain on CGF-applied and CGF free sides in bilateral impacted third molar surgery. Postoperative pain is assessed using the Visual Analogue Scale (VAS). Patients are asked to mark the pain they felt on the scale (10 cm long line) on the (1-7) days after the operation. The end of the line indicates unbearable pain, the beginning indicates no pain.

    The postoperative outcomes including pain are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days).

Study Arms (2)

CGF

EXPERIMENTAL

Participants received CGF after the operation on one side

Other: Concentrated Growth FactorOther: non-CGF

non-CGF

NO INTERVENTION

The other extraction socket is left empty

Interventions

Bilaterally impacted third molar of the patients are removed surgically and concentrated growth factor is placed in one of the extraction sockets.

CGF
non-CGFOTHER

The other extraction socket is left empty for control purposes.

CGF

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
  • Patients without any systemic disease
  • Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.

You may not qualify if:

  • Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
  • Having a systemic viral, fungal or bacterial infection
  • Patients with acute or chronic maxillary sinusitis
  • Suspected or diagnosed pregnancy and nursing mothers
  • Patients with heart and vascular diseases
  • Patients with liver disease, haematological disease and neoplastic disease
  • Patients who have recently received anti-inflammatory therapy
  • Patients with chronic medication use (antihistamines, NSAIDs, steroids and antidepressants)
  • Patients predisposed to psychotic or psychopathic tendencies
  • Patients with rheumatic diseases, blood diseases, diabetes mellitus
  • Patients at cardiological risk of infective endocarditis
  • Patients under antibiotic pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mert Zeytinoğlu

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 9, 2025

Study Start

May 1, 2017

Primary Completion

January 1, 2018

Study Completion

June 5, 2018

Last Updated

April 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations