Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)
Effect of Hyaluronic Acid on Early and Late Tissue Healing After Removal of Impacted Mandibular Third Molars - A Double-blind, Randomized Controlled Clinical Trial
1 other identifier
interventional
102
1 country
1
Brief Summary
Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of HY.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
November 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedSeptember 1, 2022
August 1, 2022
1.4 years
April 16, 2021
August 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Probing depth at adjacent second molar
Probing depth will be measured from the gingival margin to the bottom of the periodontal pocket measured in mm with a graduated periodontal probe at disco-buccal, distal and disco-lingual aspect of the second molar
1 year
Study Arms (3)
Hyaluronic acid
ACTIVE COMPARATORhyaluronic acid gel application after lower third molar removal
Hyaluronic acid+carrier
ACTIVE COMPARATORhyaluronic acid gel application together with a carrier after lower third molar removal
Standard treatment
NO INTERVENTIONstandard treatment after lower third molar removal (i.e., blood clot only)
Interventions
After lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure.
After lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure.
Eligibility Criteria
You may qualify if:
- Patients elder than 18 years;
- uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
- group II- or III- B or C according to Pell-Gregory (1933);
- a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.
You may not qualify if:
- Patients with chronic diseases and/or
- taking any medication, influencing hard and soft tissue healing;
- acute pain/infection of the surgical region;
- untreated periodontal disease;
- patients smoking \> 10 cigarettes per day;
- pregnancy;
- history of hypersensitivity or allergy to HY;
- absence of an adjacent second molar;
- presence of caries or restoration on the distal aspect of the adjacent second molar; and
- inability to attend the follow-up appointments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic of Dentistry, Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
May 3, 2021
Study Start
November 29, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
September 1, 2022
Record last verified: 2022-08