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Status unknownNCT04853589Updated Sep 1, 2022

Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

An interventional study of Hyaluronic acid gel and Hyaluronic acid gel + carrier in Alveolar Osteitis, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-09-01.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Alveolar Osteitis

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03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 41 interventional studies indexed under Dry Socket.

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Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. > 18 years;
  2. Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
  3. Diagnosis of AO based on the criteria of Blum (Blum 2002)

Exclusion criteria

Exclusion Criteria:

  1. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
  2. Pregnancy;
  3. History of or allergy to HY;
  4. Inability to attend follow-up appointments; Intake of preoperative antibiotics.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Hyaluronic acid

    hyaluronic acid gel application

    Device: Hyaluronic acid gel

  • Active comparator
    Hyaluronic acid+carrier

    hyaluronic acid gel application together with a carrier

    Device: Hyaluronic acid gel + carrier

  • No intervention
    Standard treatment

    standard treatment (i.e., blood clot only)

Interventions

  • DeviceHyaluronic acid gel

    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.

  • DeviceHyaluronic acid gel + carrier

    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.

06

What researchers measure

Primary outcomes

  1. Pain perception by the patient

    VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2021 (actual). Primary completion is estimated for May 2023, 24 months after the start.

Of 22 interventional studies with no phase under Dry Socket, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2021
First posted
Apr 21, 2021
StartActual
May 1, 2021
Primary completionEst.
May 1, 2023
CompletionEst.
May 1, 2023
Last update
Sep 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04853589
Responsible party
Danijel Domic DMD (Dental medical doctor, Medical University of Vienna) — Principal investigator
First posted
Apr 21, 2021
Start date
May 1, 2021
Primary completion
May 1, 2023 (estimated)
Completion
May 1, 2023 (estimated)
Last update
Sep 1, 2022

Study contacts

Danijel Domic, DMD
Contact
Danijel.domic@meduniwien.ac.at
+4369917230592

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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