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Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)

Primary Purpose

Tooth, Impacted

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hyaluronic acid gel
Hyaluronic acid gel + carrier
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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 after lower third molar removal

hyaluronic acid gel application together with a carrier after lower third molar removal

standard treatment after lower third molar removal (i.e., blood clot only)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2021
Last Updated
August 29, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04869306
Brief Title
Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)
Official Title
Effect of Hyaluronic Acid on Early and Late Tissue Healing After Removal of Impacted Mandibular Third Molars - 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
November 29, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Active Comparator
Arm Description
hyaluronic acid gel application after lower third molar removal
Arm Title
Hyaluronic acid+carrier
Arm Type
Active Comparator
Arm Description
hyaluronic acid gel application together with a carrier after lower third molar removal
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
standard treatment after lower third molar removal (i.e., blood clot only)
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid gel
Intervention Description
After lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid gel + carrier
Intervention Description
After lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure.
Primary Outcome Measure Information:
Title
Probing depth at adjacent second molar
Description
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
Time Frame
1 year

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: 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. Exclusion Criteria: 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.
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
Tobias Lang, Dr.med.dent.
Phone
+43(0)1400704109
Email
tobias.lang@meduniwien.ac.at

12. IPD Sharing Statement

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Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)

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