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The Efficacy of High Molecular Weight 0.8% Hyaluronic Acid on the Postoperative Sequelae and Soft Tissue Healing After Surgical Removal of Impacted Mandibular Third Molar (Randomized Clinical Trial Study)

The Efficacy of High Molecular Weight 0.8% Hyaluronic Acid on the Postoperative Sequelae and Soft Tissue Healing After Surgical Removal of Impacted Mandibular Third Molar (Randomized Clinical Trial Study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260110003
Enrollment
44
Registered
2026-01-10
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Impacted mandibular third molar Postoperative pain Trismus Postoperative edema Soft tissue wound healing Molar Third Tooth Impacted Hyaluronic Acid Wound Healing Pain Postoperative Trismus Edema Oral Surgery High molecular weight

Interventions

0.8% high molecular weight hyaluronic acid gel will be applied locally and immediately to the extraction socket following the surgical removal of the third molar. The gel is incorporated into a gelati
Experimental Drug,Placebo Comparator Drug
HA group ,Placebo Control (Gelatin Sponge)

Sponsors

University of Baghdad / College of Dentistry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1- Any patient with bilaterally impacted or unerupted mandibular third molar, in need of surgical extraction, which were evaluated clinically and by radiological examination. 2- Patients who were willing to comply with the study and were available for follow-up. 3- Patients with good oral hygiene and the surgical site free of acute infection. 4- Patients without any systemic disease that might affect the healing process, such as uncontrolled diabetes.

Exclusion criteria

Exclusion criteria: 1- Medical conditions that prevent surgical intervention, such as patients with bleeding disorders, recent myocardial infarction, psychiatric problems, uncontrolled systemic disease, and patients with a heart pacemaker, immunocompromised status, and who were taking corticosteroids and anti-inflammatory drugs. 2- Recent history of head and neck radiotherapy. 3- Pregnancy and female patients taking contraceptives. 4- Poor oral hygiene and/or active advanced periodontal disease, and/or patients with acute local infection in relation to the third molar, such as Pericoronitis. 5- Patients are unable to comply with follow-up. 6- Periapical pathology related to the impacted tooth. 7- Smoking.

Design outcomes

Primary

MeasureTime frame
Pain Intensity 1st, 3rd, and 7th day postoperatively Numerical Rating Scale (NRS) in written form,Facial Swelling Preoperatively (baseline), 3rd day, and 7th day postoperatively Average measurements of three facial lines connecting five specific points on the face, according to the Gabka and Matsumara method,Maximum Mouth Opening (MIO) Preoperatively (baseline), 3rd day, and 7th day postoperatively Distance between maxillary and mandibular central incisors measured in millimetres using a digital Vernier caliper

Secondary

MeasureTime frame
Early soft tissue wound healing 7th day postoperatively Early Wound Healing Scoring index (EHS), which ranges from 0 (worst healing) to 10 (excellent healing), assessing re-epithelialisation, haemostasis, and inflammation

Countries

Iraq

Contacts

Public ContactSafaa Assim

University of Baghdad, College of Dentistry

safamohammed1994@gmail.com009647878316199

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026