Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Medical University of Vienna

Status: Enrolling

Conditions: Alveolar Osteitis

Treatments: Device: Hyaluronic acid gel + carrier; Device: Hyaluronic acid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04853589

1049/2021

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

4. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;

5. Pregnancy;

6. History of hypersensitivity or allergy to HY;

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Hyaluronic acid

Active Comparator group

Description:

hyaluronic acid gel application

Treatment:

Device: Hyaluronic acid gel

Hyaluronic acid+carrier

Active Comparator group

Description:

hyaluronic acid gel application together with a carrier

Treatment:

Device: Hyaluronic acid gel + carrier

Standard treatment

No Intervention group

Description:

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