- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05615272
Treatment of Alveolar Osteitis: Traditional or Regenerative?
A Clinical Investigation of the Efficacy of Platelet Rich Fibrin (Bio-PRF) Compared to Alveogyl in the Treatment of Alveolar Osteitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maeve Cooney
- Phone Number: +353872529024
- Email: maeve.cooney@dental.tcd.ie
Study Locations
-
-
-
Dublin, Ireland
- Recruiting
- Dublin Dental University Hospital
-
Contact:
- Maeve Cooney
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Intervention group
Other Names:
|
Active Comparator: Alveogyl
Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol.
|
Control group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postoperative pain levels: Day 0 to Day 3
Time Frame: Day 3 following intervention
|
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
Time Frame: Day 7 following intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing
Time Frame: Day 7 following intervention
|
Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index
|
Day 7 following intervention
|
Quality of Life Measurements (QoL)
Time Frame: Day 7 following intervention
|
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.
|
Day 7 following intervention
|
Collaborators and Investigators
Investigators
- Study Director: Anna Dr Beattie, Specialist Oral Surgeon
- Study Director: John Ed Mr O'Connell, Consultant Maxillofacial Surgeon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0733
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Bio-PRF
-
Shahid Beheshti University of Medical SciencesUnknownAlveolar Bone LossIran, Islamic Republic of
-
Hams Hamed AbdelrahmanCompleted
-
Yuzuncu Yıl UniversityActive, not recruitingImpacted Third Molar ToothTurkey
-
Shahid Beheshti University of Medical SciencesUnknownAtrophy | Alveolar Bone LossIran, Islamic Republic of
-
Bezmialem Vakif UniversityCompletedCondition | Blood Clot | Periodontoclasia | Gingiva; Injury | Gingiva DisorderTurkey
-
Cairo UniversityUnknown
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Sajjad Ahmed ShakirCompleted
-
Ahmed adel shaabanUnknownBone Density Increased