Alveolar OsteitisNCT05615272
Treatment of Alveolar Osteitis: Traditional or Regenerative?
A study testing Bio-PRF and Alveogyl in people with Alveolar Osteitis and Dry Socket, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis, Dry Socket, Pain
- What is being tested?
- Bio-PRF and Alveogyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Dublin Dental University Hospital
Dublin
Maeve Cooney
About this study
Official title: 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.
Read more
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
- Being tested
- Bio-PRF, Alveogyl
- Medical subject headings
- Dry Socket, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-PRFBiological
Also called Blood Sample
Intervention group
AlveogylDrug
Also called Intraalveolar Dressing
Control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Bio-PRF |
| Alveogyl | Active comparator | Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol. Receives: Drug: Alveogyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 7 following intervention
Secondary outcomes (2)
Healing
Healing will be measured clinically by second blinded assessor using a modified version of the Landry Healing Index
Measured: Day 7 following intervention
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.
Measured: Day 7 following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Oct 2022
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maeve Cooney, University of Dublin, Trinity College
- Investigators
- Anna Dr Beattie, Study director, Specialist Oral SurgeonJohn Ed Mr O'Connell, Study director, Consultant Maxillofacial Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615272
- Sponsor's protocol ID
- 0733
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the Efficacy of Platelet Rich Fibrin (Bio-PRF) Compared to Alveogyl in the Treatment of Alveolar Osteitis
- ClinicalTrials.gov ID
- NCT05615272
- Acronym / sponsor ID
- 0733
- Conditions
- Alveolar Osteitis, Dry Socket, Pain, Healing, Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-PRF | Experimental | Biological: Bio-PRFThis 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 | Active comparator | Drug: AlveogylAlveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-PRFAlso: Blood SampleIntervention group | Biological | Bio-PRF |
| AlveogylAlso: Intraalveolar DressingControl group | Drug | Alveogyl |
Primary outcome
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.
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.
2 secondary outcomes
Healing
Time frame: Day 7 following intervention
Quality of Life Measurements (QoL)
Time frame: Day 7 following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Dr Beattie study director
Specialist Oral Surgeon
John Ed Mr O'Connell study director
Consultant Maxillofacial Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-PRF and Alveogyl in people with Alveolar Osteitis and Dry Socket, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maeve Cooney (+353872529024, maeve.cooney@dental.tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain levels: Day 0 to Day 3 (time frame: Day 3 following intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.