Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

NCT04853589 | Unknown

• 1 other identifier: 1049/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Hyaluronic acid

ACTIVE COMPARATOR

hyaluronic acid gel application

Device: Hyaluronic acid gel

Hyaluronic acid+carrier

ACTIVE COMPARATOR

hyaluronic acid gel application together with a carrier

Device: Hyaluronic acid gel + carrier

Standard treatment

NO INTERVENTION

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

Interventions

Hyaluronic acid gel 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

Hyaluronic acid gel + carrier 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.

Hyaluronic acid+carrier

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years;
• Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
• Diagnosis of AO based on the criteria of Blum (Blum 2002)

You may not qualify if:

• Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
• Pregnancy;
• History of hypersensitivity or allergy to HY;
• Inability to attend follow-up appointments; Intake of preoperative antibiotics.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University Clinic of Dentistry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Danijel Domic, DMD

CONTACT

+4369917230592; Danijel.domic@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental medical doctor

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

AU (1)