Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial

Sponsors

Lead Sponsor: Medical University of Vienna

Source Medical University of Vienna
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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2022-05-01
Primary Completion Date 2022-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain perception by the patient 2 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Hyaluronic acid gel

Description: 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.

Arm Group Label: Hyaluronic acid

Intervention Type: Device

Intervention Name: Hyaluronic acid gel + carrier

Description: 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.

Arm Group Label: Hyaluronic acid+carrier

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

99 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Danijel Domic, DMD

Phone: +4369917230592

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Medical University of Vienna

Investigator Full Name: Danijel Domic DMD

Investigator Title: Dental medical doctor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Hyaluronic acid

Type: Active Comparator

Description: hyaluronic acid gel application

Label: Hyaluronic acid+carrier

Type: Active Comparator

Description: hyaluronic acid gel application together with a carrier

Label: Standard treatment

Type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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