Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

NCT ID: NCT04853589

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-01

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.

Conditions

Alveolar Osteitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hyaluronic acid

hyaluronic acid gel application

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid gel

Intervention Type: DEVICE

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+carrier

hyaluronic acid gel application together with a carrier

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid gel + carrier

Intervention Type: DEVICE

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.

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Danijel Domic DMD

Dental medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinic of Dentistry, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Danijel Domic, DMD

Role: CONTACT

Danijel.domic@meduniwien.ac.at

+4369917230592

Facility Contacts

Danijel Domic, Dr.med.dent.

Role: primary

danijel.domic@meduniwien.ac.at

+43(0)1400704121

Peter Bauer, Dr.med.dent.

Role: backup

peter.bauer@meduniwien.ac.at

+43(0)1400704109

Other Identifiers

1049/2021

Identifier Type: -

Identifier Source: org_study_id