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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04869306
Enrollment
102
Registered
2021-05-03
Start date
2021-11-29
Completion date
2023-05-01
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth, Impacted

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.

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Probing depth at adjacent second molar1 yearProbing 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

Countries

Austria

Contacts

Primary ContactDanijel Domic, DMD
Danijel.domic@meduniwien.ac.at+4369917230592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026