An interventional study of Bio-PRF and Alveogyl in Alveolar Osteitis, Dry Socket and Pain, sponsored by University of Dublin, Trinity College. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by University of Dublin, Trinity College · Not applicable, Interventional, and Treatment
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.
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →University of Dublin, Trinity College is the lead sponsor of 73 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
This is a blood-derived platelet rich concentrate from the patient's whole blood sample. The patient typically donates two 9ml (1.5 tablespoons) vials of blood that is then spun in a centrifuge.
Biological: Bio-PRF
Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol.
Drug: Alveogyl
Intervention group
Also known as: Blood Sample
Control group
Also known as: Intraalveolar Dressing
Change in postoperative pain levels: Day 0 to Day 3
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.
Time frame: Day 3 following intervention
Change in postoperative pain levels: Day 0 to Day 7
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.
Time frame: Day 7 following intervention
Healing
Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index
Time frame: Day 7 following intervention
Quality of Life Measurements (QoL)
The patient's QoL will be assessed using a questionnaire modified from the postoperative symptom severity scale (PoSSe) ranging from 1-5, where 1 correlates to no impact on their quality of life and 5 signifies major impact on their quality of life. Higher scores will mean worse outcome if by Day 7, the patient's QoL scores remain high.
Time frame: Day 7 following intervention
Started Oct 2022 (actual). Primary completion is estimated for Mar 2024, 17 months after the start.
Of 22 interventional studies with no phase under Dry Socket, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 17 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Dublin, Trinity College