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

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth, Impacted
• Intervention / Treatment: Device: Hyaluronic acid gel; Device: Hyaluronic acid gel + carrier

• Study Type: Interventional
• Enrollment (Anticipated): 102
• 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: Tobias Lang, Dr.med.dent.; Phone Number: +43(0)1400704109; Email: tobias.lang@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients elder than 18 years;
2. uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
3. group II- or III- B or C according to Pell-Gregory (1933);
4. a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.

Exclusion Criteria:

1. Patients with chronic diseases and/or
2. taking any medication, influencing hard and soft tissue healing;
3. acute pain/infection of the surgical region;
4. untreated periodontal disease;
5. patients smoking > 10 cigarettes per day;
6. pregnancy;
7. history of hypersensitivity or allergy to HY;
8. absence of an adjacent second molar;
9. presence of caries or restoration on the distal aspect of the adjacent second molar; and
10. inability to attend the follow-up appointments.

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 after lower third molar removal	Device: Hyaluronic acid gel; After lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure.
Active Comparator: Hyaluronic acid+carrier; hyaluronic acid gel application together with a carrier after lower third molar removal	Device: Hyaluronic acid gel + carrier; After lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure.
No Intervention: Standard treatment; standard treatment after lower third molar removal (i.e., blood clot only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 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 30, 2021
• First Posted (Actual): May 3, 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: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2244/2020

Drug and device information, study documents

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