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Treatment of Alveolar Osteitis: Traditional or Regenerative?

Primary Purpose

Alveolar Osteitis, Dry Socket, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Bio-PRF
Alveogyl
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Osteitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Dublin Dental University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bio-PRF

Alveogyl

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Healing
Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index
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.

Full Information

First Posted
October 24, 2022
Last Updated
November 7, 2022
Sponsor
University of Dublin, Trinity College
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1. Study Identification

Unique Protocol Identification Number
NCT05615272
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis, Dry Socket, Pain, Healing, Tooth Extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bio-PRF
Arm Type
Experimental
Arm 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.
Arm Title
Alveogyl
Arm Type
Active Comparator
Arm Description
Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol.
Intervention Type
Biological
Intervention Name(s)
Bio-PRF
Other Intervention Name(s)
Blood Sample
Intervention Description
Intervention group
Intervention Type
Drug
Intervention Name(s)
Alveogyl
Other Intervention Name(s)
Intraalveolar Dressing
Intervention Description
Control group
Primary Outcome Measure Information:
Title
Change in postoperative pain levels: Day 0 to Day 3
Description
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.
Time Frame
Day 3 following intervention
Title
Change in postoperative pain levels: Day 0 to Day 7
Description
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.
Time Frame
Day 7 following intervention
Secondary Outcome Measure Information:
Title
Healing
Description
Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index
Time Frame
Day 7 following intervention
Title
Quality of Life Measurements (QoL)
Description
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.
Time Frame
Day 7 following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maeve Cooney
Phone
+353872529024
Email
maeve.cooney@dental.tcd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Dr Beattie
Organizational Affiliation
Specialist Oral Surgeon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Ed Mr O'Connell
Organizational Affiliation
Consultant Maxillofacial Surgeon
Official's Role
Study Director
Facility Information:
Facility Name
Dublin Dental University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeve Cooney

12. IPD Sharing Statement

Learn more about this trial

Treatment of Alveolar Osteitis: Traditional or Regenerative?

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