A Clinical Investigation of the Efficacy of Platelet Rich Fibrin (Bio-PRF) Compared to Alveogyl in the Treatment of Alveolar Osteitis

NCT05615272 NA UNKNOWN

Alveolar osteitis, commonly referred to as dry socket, is a common painful postoperative complication following tooth extraction. It is defined as pain in and around an extraction socket which increases at any time between one and three days following extraction, accompanied by partial or total loss of the blood clot from the socket, with or without halitosis (Blum, 2002). The incidence of the complication varies from 1-5% for routine extractions up to approximately 30% for third molar extractions. There are a variety of factors that contribute to the incidence of dry socket including tissue trauma, smoking in the early postoperative period and the oral contraceptive pill. Although it is a self- limiting condition, symptoms can be very debilitating for patients and therefore following diagnosis, immediate treatment should be provided to expedite resolution and to their improve quality of life during the healing period. Treatment options for dry socket vary from rinsing of the socket, regular analgesia and sometimes placement of an obtundent, sedative dressing such as Alveogyl or a zinc oxide eugenol alternative. This study will aim to compare two treatments for patients who present with alveolar osteitis (dry socket) to Dublin Dental University Hospital after tooth extraction. Following randomisation, one of two treatment modalities will be used, either a experimental treatment (Bio-PRF) or a positive control (Alveogyl). The results of this study will enable us to learn more about the efficacy of these treatment options for dry socket and how they affect patients.

Details

Lead sponsor	University of Dublin, Trinity College
Phase	NA
Status	UNKNOWN
Enrolment	58
Start date	2022-10-01
Completion	2024-07

Conditions

• Alveolar Osteitis
• Dry Socket
• Pain
• Healing
• Tooth Extraction

Interventions

• Bio-PRF
• Alveogyl

Primary outcomes

• Change in postoperative pain levels: Day 0 to Day 3 — Day 3 following intervention
  Pain will be measured using a pain diary with VAS scale (0-100) at baseline and Day 3. The changes in patient pain levels from baseline will be compared to Day 3 for each group.
• Change in postoperative pain levels: Day 0 to Day 7 — Day 7 following intervention
  Pain will be measured using a pain diary with VAS scale (0-100) at baseline and Day 7. The changes in patient pain levels from baseline will be compared to Day 7 for each group.

Countries

Ireland