Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.

NCT07114523 | Recruiting DMC

• 1 other identifier: 3566/DHYD-HDDD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Impacted mandibular third molars can cause various complications to the adjacent second molars, such as dental caries, periodontitis, or root resorption. These complications often progress silently and asymptomatically. A typical scenario involves a mesioangularly impacted third molar exerting pressure on the distal alveolar bone of the second molar, resulting in persistent food impaction that is difficult for patients to clean. Furthermore, the surgical removal of deeply impacted or severely angulated mandibular third molars often requires bone removal in the area adjacent to the second molar. These factors may exacerbate distal periodontal defects of the second molar, especially in individuals over the age of 25. This research focuses on evaluating the effectiveness of a new-generation collagen membrane in promoting healing after the extraction of impacted mandibular third molars in patients at risk of distal periodontal tissue damage to the second molars

Conditions

Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• Distal periodontal tissue status

  distal periodontal tissue status was assessed using variables of pocket depth

  preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)

Secondary Outcomes (1)

• Distal bone level

  at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).

Other Outcomes (3)

• Postoperative pain

  on the 1st, 3rd, 7th day after surgery

• Postoperative swelling

  on the 1st, 3rd, 7th day after surgery

• Soft tissue healing

  on the 7th day after surgery

Study Arms (2)

study

EXPERIMENTAL

apply collagen membrane on distal surface of second molar after third molar surgery

Procedure: collagen membrane

control

ACTIVE COMPARATOR

standard third molar surgery without any application

Procedure: third molar surgery

Interventions

collagen membrane PROCEDURE

collagen membrane apply to distal surface of second molar after third molar surgery

study

third molar surgery PROCEDURE

standard third molar surgery without any additional application

control

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh city

Ho Chi Minh City, Vietnam

RECRUITING

Central Study Contacts

Phong Cu Lam, MD.DDS

CONTACT

+84932114888; lamcuphong@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, clinical professor

Model Details: This type of interventional study in dentistry is referred to as a split-mouth design. In this design, the intervention subjects have bilaterally symmetrical conditions within the oral cavity, allowing one side to serve as the intervention group while the contralateral side serves as the control group.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

VN (1)