Using a collagen membrane to help the gum behind the second molar heal after removing an impacted lower wisdom tooth

Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

This trial will try a new collagen membrane to help the gums and bone behind second molars heal after removal of impacted lower wisdom teeth in adults aged 25 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City (other)
• Locations: 1 site (Ho Chi Minh City)
• Trial ID: NCT07114523 on ClinicalTrials.gov

What this trial studies

This interventional study places a new-generation collagen membrane at the distal aspect of the second molar when removing mesioangular or horizontally impacted mandibular third molars in adults 25 years and older. Patients with symmetrical bilateral impactions are enrolled so treated sites can be compared with the opposite side within the same patient. Clinical and radiographic measures of distal periodontal healing will be followed over time to determine whether the membrane improves tissue and bone recovery. Participants are excluded for bleeding or immune disorders, relevant allergies, or pregnancy, and all must provide informed consent.

Who should consider this trial

Good fit: Adults aged 25 or older with mesioangular or horizontal impacted lower third molars (Pell-Gregory B or C), symmetrical bilateral impactions with similar angulation, intact second molar CEJs, and who consent to participate.

Not a fit: Patients with coagulation or immune disorders, allergies to local anesthetic or porcine-derived products, pregnant individuals, or those whose molars do not meet the inclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the membrane could reduce distal periodontal defects and improve gum and bone healing behind second molars after impacted lower wisdom tooth removal, preserving tooth health.

How similar studies have performed: Previous guided-tissue regeneration and barrier membrane approaches have shown benefit for distal periodontal healing after third molar removal, so this approach builds on existing, partially successful methods.

Eligibility criteria

Inclusion Criteria:

* Patients aged 25 years or older.
* Patients with mesioangular or horizontally impacted mandibular third molars. The highest point of mandibular third molars are lower than the occlusal surface of adjacent second molars (classified B, C according to Pell - Gregory's category).
* Patients with symmetrical lower third molars on both sides with same classification according to Pell - Gregory's category. The difference of third molars inclination on both side is not more than 15°.
* Patients with lower second molars on both sides have no cavities or fillings that affect the determination of the cemento-enamel junction.
* Patients are explained, counseled clearly and sign their consent to participate in the study.

Exclusion Criteria:

* Patients with coagulation or immune disorders.
* Patients allergic to local anesthetics (Lidocaine 2% with Adrenaline 1:100,000) or any drugs used in the study.
* Patients allergic to products or food derived from pigs.
* Pregnant or breastfeeding patients.
* Patients who smoke.
* Patients with systemic conditions that contraindicate surgical procedures.
* Patients with clinical or radiographic signs suggestive of tumors (benign or malignant) associated with or in proximity to the mandibular third molar.
* Patients with missing mandibular second molars.

Where this trial is running

Ho Chi Minh City

• University of Medicine and Pharmacy at Ho Chi Minh city — Ho Chi Minh City, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Phong Cu Lam, MD.DDS

Conditions: Periodontal Defect