Treatment of Alveolar Osteitis: Traditional or Regenerative?

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Alveolar Osteitis, Dry Socket, Pain, Healing, Tooth Extraction

Intervention / Treatment
-----------------
* Biological: Bio-PRF
* Drug: Alveogyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females adults at least 18 years old A diagnosis of alveolar osteitis following tooth extraction based on patients having both pain and exposed bone Good command of the English language Willingness to keep a diary of symptoms and travel for the review appointment on day 7 following intervention Exclusion Criteria: Pregnant or breastfeeding women Current or previous bisphosphonate used or history of radiotherapy to the jaws Allergy or intolerance to study materials Lack of capacity to consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-PRF<br>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<br>* Intervention group<br>* Other names: Blood Sample;|
| Active Comparator: Alveogyl<br>Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol. | Drug: Alveogyl<br>* Control group<br>* Other names: Intraalveolar Dressing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Day 7 following intervention |