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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-PRF | Experimental | 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. |
|
| Alveogyl | Active Comparator | Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-PRF | Biological | Intervention group |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 7 following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Healing | Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maeve Cooney | Contact | +353872529024 | maeve.cooney@dental.tcd.ie |
| Name | Affiliation | Role |
|---|---|---|
| Anna Dr Beattie | Specialist Oral Surgeon | Study Director |
| John Ed Mr O'Connell | Consultant Maxillofacial Surgeon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin Dental University Hospital | Recruiting | Dublin | Ireland |
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| ID | Term |
|---|---|
| D004368 | Dry Socket |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Alveogyl | Drug | Control group |
|
|
| Day 7 following intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |