Alveolar OsteitisNCT04853589
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis
A study testing Hyaluronic acid gel and Hyaluronic acid gel + carrier in people with Alveolar Osteitis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Hyaluronic acid gel and Hyaluronic acid gel + carrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2021to 1 May 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years;
- Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
- Diagnosis of AO based on the criteria of Blum (Blum 2002)
Who cannot join
- Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
- Pregnancy;
- History of hypersensitivity or allergy to HY;
- Inability to attend follow-up appointments; Intake of preoperative antibiotics.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Clinic of Dentistry, Medical University of Vienna
Vienna, 1090
Danijel Domic, Dr.med.dent., +43(0)1400704121, danijel.domic@meduniwien.ac.at
Peter Bauer, Dr.med.dent., +43(0)1400704109, peter.bauer@meduniwien.ac.at
About this study
Official title: Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.
- Conditions
- Alveolar Osteitis
- Being tested
- Hyaluronic acid gel, Hyaluronic acid gel + carrier
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelDevice
After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 1 will receive hyaluronic acid gel.
Hyaluronic acid gel + carrierDevice
After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 2 will receive hyaluronic acid gel together with a collagen carrier.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Active comparator | hyaluronic acid gel application Receives: Device: Hyaluronic acid gel |
| Hyaluronic acid+carrier | Active comparator | hyaluronic acid gel application together with a carrier Receives: Device: Hyaluronic acid gel + carrier |
| Standard treatment | No intervention | standard treatment (i.e., blood clot only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception by the patient
VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danijel Domic DMD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853589
- Sponsor's protocol ID
- 1049/2021
- Status last verified
- Aug 2022
- First submitted
- 16 Apr 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04853589
- Acronym / sponsor ID
- 1049/2021
- Conditions
- Alveolar Osteitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 21 Apr 2021 (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 (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Active comparator | Device: Hyaluronic acid gelhyaluronic acid gel application |
| Hyaluronic acid+carrier | Active comparator | Device: Hyaluronic acid gel + carrierhyaluronic acid gel application together with a carrier |
| Standard treatment | No intervention | –standard treatment (i.e., blood clot only) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years;
- Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
- Diagnosis of AO based on the criteria of Blum (Blum 2002)
Key exclusion criteria (4 listed)
- Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
- Pregnancy;
- History of hypersensitivity or allergy to HY;
- Inability to attend follow-up appointments; Intake of preoperative antibiotics.
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 |
|---|---|---|
| Hyaluronic acid gelAfter the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 1 will receive hyaluronic acid gel. | Device | Hyaluronic acid |
| Hyaluronic acid gel + carrierAfter the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 2 will receive hyaluronic acid gel together with a collagen carrier. | Device | Hyaluronic acid+carrier |
Primary outcome
Pain perception by the patient
Time frame: 2 weeks
VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel and Hyaluronic acid gel + carrier in people with Alveolar Osteitis, run by Medical University of Vienna at 1 site in Austria.
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 3 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 1 Sep 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 Austria. 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 Danijel Domic, DMD (+4369917230592, Danijel.domic@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception by the patient (time frame: 2 weeks). 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 1 Sep 2022.