Clinical trial NCT05615272: Treatment of Alveolar Osteitis: Traditional or Regenerative?
Official title: A Clinical Investigation of the Efficacy of Platelet Rich Fibrin (Bio-PRF) Compared to Alveogyl in the Treatment of Alveolar Osteitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Osteitis
Dry Socket
Pain
Healing
Tooth Extraction
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in postoperative pain levels: Day 0 to Day 3
timeFrame: Day 3 following intervention
measure: Change in postoperative pain levels: Day 0 to Day 7
timeFrame: Day 7 following intervention
Secondary outcomes:
measure: Healing
timeFrame: Day 7 following intervention
measure: Quality of Life Measurements (QoL)
timeFrame: Day 7 following intervention
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dublin Dental University Hospital
Study officials:
affiliation: Specialist Oral Surgeon
name: Anna Dr Beattie
role: STUDY_DIRECTOR
affiliation: Consultant Maxillofacial Surgeon
name: John Ed Mr O'Connell
role: STUDY_DIRECTOR
References: