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

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.

Study Overview

• Status: Recruiting
• Conditions: Alveolar Osteitis
• Intervention / Treatment: Device: Hyaluronic acid gel; Device: Hyaluronic acid gel + carrier

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danijel Domic, DMD; Phone Number: +4369917230592; Email: Danijel.domic@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • University Clinic of Dentistry, Medical University of Vienna
    • Contact: Danijel Domic, Dr.med.dent.; Phone Number: +43(0)1400704121; Email: danijel.domic@meduniwien.ac.at
    • Contact: Peter Bauer, Dr.med.dent.; Phone Number: +43(0)1400704109; Email: peter.bauer@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception by the patient	VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain	2 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Osteitis; Dry Socket; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 1049/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No