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Completed

NCT Number: NCT04507009

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

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.

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Key information

Conditions

Alveolar Osteitis Dry Socket Mouth Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, 52200, Turkey (Türkiye)

About this study

In the present study, 60 healthy patients > 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ozone

Device

topical gaseous ozone application

CGF

Other

concentrated growth factor (CGF) application

traditional treatment

Other

Alvogyl application

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Granulation tissue health

    Time frame: postoperative 1st, 3rd, 7th days

    Granulation tissue formation in the area after treatment will be evaluated clinically. Granulation tissue will be scored as healthy (pink color and no bleeding on probing) and unhealthy granulation tissue (dark red in color and usually bleeding on probing).

  2. Inflamation severity

    Time frame: postoperative 1st, 3rd, 7th days

    The severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva

    • Slight inflammation-slight discoloration, mild edema. no probing on bleeding,
    • Moderate inflammation - redness, edema. bleeding on probing,
    • Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding

  3. Change in the quality of postoperative life after the procedures performed

    Time frame: postoperative 7th day

    The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.

Other outcomes

  1. Oral hygiene degree

    Time frame: Evaluation of the oral hygiene before operation

    Oral hygiene of the patient will be evaluated in 3 groups as poor, moderate and good.

    • Good
    • Patients with a low incidence of active caries,
    • Patients with no bleeding and non-inflamed gums, as well as no plaque, calculus, and gingival pocket formation.
    • Bad
    • Patients with periodontitis, inflamed gums, bleeding on probing, pocket formation,calculus
    • Patients with active caries.
    • Moderate
    • Patients other than these two groups will be evaluated as moderate.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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