Treatment of Alveolar Osteitis: Traditional or Regenerative?

University of Dublin, Trinity College

Status: Enrolling

Conditions: Tooth Extraction; Dry Socket; Alveolar Osteitis; Pain; Healing

Treatments: Drug: Alveogyl; Biological: Bio-PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT05615272

0733

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Bio-PRF

Experimental group

Description:

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.

Treatment:

Biological: Bio-PRF

Alveogyl

Active Comparator group

Description:

Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol.

Treatment:

Drug: Alveogyl