Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis
Primary Purpose
Alveolar Osteitis
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hyaluronic acid gel
Hyaluronic acid gel + carrier
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Osteitis
Eligibility Criteria
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.
Sites / Locations
- University Clinic of Dentistry, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Hyaluronic acid
Hyaluronic acid+carrier
Standard treatment
Arm Description
hyaluronic acid gel application
hyaluronic acid gel application together with a carrier
standard treatment (i.e., blood clot only)
Outcomes
Primary Outcome Measures
Pain perception by the patient
VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04853589
First Posted
April 16, 2021
Last Updated
August 29, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04853589
Brief Title
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis
Official Title
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid
Arm Type
Active Comparator
Arm Description
hyaluronic acid gel application
Arm Title
Hyaluronic acid+carrier
Arm Type
Active Comparator
Arm Description
hyaluronic acid gel application together with a carrier
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
standard treatment (i.e., blood clot only)
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid gel
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid gel + carrier
Intervention 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.
Primary Outcome Measure Information:
Title
Pain perception by the patient
Description
VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danijel Domic, DMD
Phone
+4369917230592
Email
Danijel.domic@meduniwien.ac.at
Facility Information:
Facility Name
University Clinic of Dentistry, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danijel Domic, Dr.med.dent.
Phone
+43(0)1400704121
Email
danijel.domic@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Peter Bauer, Dr.med.dent.
Phone
+43(0)1400704109
Email
peter.bauer@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis
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