Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis

NCT04507009 | Completed

• 1 other identifier: A-2005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.

Conditions

Alveolar Osteitis

Keywords

Alveolitis; Dry socket; Ozone; CGF

Outcome Measures

Primary Outcomes (1)

• Change in post-operative pain assessed: visual analog (VAS) scale

  For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10). 0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.

  6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day

Secondary Outcomes (3)

• Granulation tissue health

  postoperative 1st, 3rd, 7th days

• Inflamation severity

  postoperative 1st, 3rd, 7th days

• Change in the quality of postoperative life after the procedures performed

  postoperative 7th day

Other Outcomes (1)

• Oral hygiene degree

  Evaluation of the oral hygiene before operation

Study Arms (3)

Control

ACTIVE COMPARATOR

Traditional treatment group which alvogyl applied to the socket after irrigation

Other: Traditional treatment

Ozone

EXPERIMENTAL

Ozone group which Ozone (O3) applied after irrigation of the socket

Device: Ozone

CGF +Ozone

EXPERIMENTAL

CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.

Device: Ozone; Other: CGF

Interventions

Ozone DEVICE

topical gaseous ozone application

CGF +Ozone; Ozone

CGF OTHER

concentrated growth factor (CGF) application

CGF +Ozone

Traditional treatment OTHER

Alvogyl application

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;
• With a partially or completely disintegrated blood clot in the socket
• With exposed bone that gives a dark gray appearance
• With bad odor

You may not qualify if:

• Who does not want to be volunteer for the study,
• Smokers,
• During pregnancy or lactation,
• Has a chronic systemic disorder that will affect recovery,
• Has hematological disorder
• Cooperation cannot be established,
• Previously received radiotherapy or chemotherapy,
• Patients using oral contraceptives

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Damla Torul, DDS PhD

  Ordu University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)