Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Sponsor
Medical University of Vienna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04853589
Collaborator
(none)
60
3
12

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hyaluronic acid gel
  • Device: Hyaluronic acid gel + carrier
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hyaluronic acid

hyaluronic acid gel application

Device: Hyaluronic 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.

Active Comparator: Hyaluronic acid+carrier

hyaluronic acid gel application together with a carrier

Device: Hyaluronic 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.

No Intervention: Standard treatment

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

Outcome Measures

Primary Outcome Measures

  1. Pain perception by the patient [2 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;

  2. Pregnancy;

  3. History of hypersensitivity or allergy to HY;

  4. Inability to attend follow-up appointments; Intake of preoperative antibiotics.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Danijel Domic DMD, Dental medical doctor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04853589
Other Study ID Numbers:
  • 1049/2021
First Posted:
Apr 21, 2021
Last Update Posted:
May 5, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2021