Treatment of Alveolar Osteitis: Traditional or Regenerative?

NCT05615272 | Unknown

• 1 other identifier: 0733
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Healing

  Day 7 following intervention

• Quality of Life Measurements (QoL)

  Day 7 following intervention

Study Arms (2)

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.

Biological: Bio-PRF

Alveogyl

ACTIVE COMPARATOR

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

Drug: Alveogyl

Interventions

Bio-PRF BIOLOGICAL

Intervention group

Also known as: Blood Sample

Bio-PRF

Alveogyl DRUG

Control group

Also known as: Intraalveolar Dressing

Alveogyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Dublin Dental University Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Dry Socket; Pain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anna Dr Beattie

  Specialist Oral Surgeon

  STUDY DIRECTOR

• John Ed Mr O'Connell

  Consultant Maxillofacial Surgeon

  STUDY DIRECTOR

Central Study Contacts

Maeve Cooney

CONTACT

+353872529024; maeve.cooney@dental.tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student in Oral Surgery

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 14, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

IE (1)