Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Alveolar Osteitis

Intervention / Treatment
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* Device: Hyaluronic acid gel
* Device: Hyaluronic acid gel + carrier


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years; Untreated AO after extraction of a permanent tooth (excluding wisdom teeth); Diagnosis of AO based on the criteria of Blum (Blum 2002) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid<br>hyaluronic acid gel application | Device: Hyaluronic acid gel<br>* 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.<br>|
| Active Comparator: Hyaluronic acid+carrier<br>hyaluronic acid gel application together with a carrier | Device: Hyaluronic acid gel + carrier<br>* 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.<br>|
| No Intervention: Standard treatment<br>standard treatment (i.e., blood clot only) | |

What is the study measuring?
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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 |