An interventional study of Ozone and CGF in Alveolar Osteitis, sponsored by T.C. ORDU ÜNİVERSİTESİ. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Treatment
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.
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.
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.
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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;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional treatment group which alvogyl applied to the socket after irrigation
Other: Traditional treatment
Ozone group which Ozone (O3) applied after irrigation of the socket
Device: Ozone
CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.
Device: Ozone · Other: CGF
topical gaseous ozone application
concentrated growth factor (CGF) application
Alvogyl application
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.
Time frame: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
Granulation tissue health
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).
Time frame: postoperative 1st, 3rd, 7th days
Inflamation severity
The severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva 1. Slight inflammation-slight discoloration, mild edema. no probing on bleeding, 2. Moderate inflammation - redness, edema. bleeding on probing, 3. Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding
Time frame: postoperative 1st, 3rd, 7th days
Change in the quality of postoperative life after the procedures performed
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.
Time frame: postoperative 7th day
Oral hygiene degree
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.
Time frame: Evaluation of the oral hygiene before operation
Plan to share: No — IPD can share with other researchers on demand
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T.C. ORDU ÜNİVERSİTESİ