Treatment of Alveolar Osteitis: Traditional or Regenerative?

NCT ID: NCT05615272

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bio-PRF

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.

Group Type: EXPERIMENTAL

Bio-PRF

Intervention Type: BIOLOGICAL

Intervention group

Alveogyl

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

Group Type: ACTIVE_COMPARATOR

Alveogyl

Intervention Type: DRUG

Control group

Interventions

Bio-PRF

Intervention group

Intervention Type: BIOLOGICAL

Alveogyl

Control group

Intervention Type: DRUG

Other Intervention Names

Blood Sample; Intraalveolar Dressing

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Maeve Cooney

Postgraduate Student in Oral Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Dr Beattie

Role: STUDY_DIRECTOR

Specialist Oral Surgeon

John Ed Mr O'Connell

Role: STUDY_DIRECTOR

Consultant Maxillofacial Surgeon

Locations

Dublin Dental University Hospital

Dublin, , Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Maeve Cooney

Role: CONTACT

maeve.cooney@dental.tcd.ie

+353872529024

Facility Contacts

Maeve Cooney

Role: primary

Other Identifiers

0733

Identifier Type: -

Identifier Source: org_study_id