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

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

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

Study Overview

• Status: Recruiting
• Conditions: Periodontal Defect
• Intervention / Treatment: Procedure: collagen membrane; Procedure: third molar surgery

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phong Cu Lam, MD.DDS; Phone Number: +84932114888; Email: lamcuphong@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh city, Vietnam
    • Recruiting
    • University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Phong Cu Lam, MD.DDS; Phone Number: +84932114888; Email: lamcuphong@ump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study; apply collagen membrane on distal surface of second molar after third molar surgery	Procedure: collagen membrane; collagen membrane apply to distal surface of second molar after third molar surgery
Active Comparator: control; standard third molar surgery without any application	Procedure: third molar surgery; standard third molar surgery without any additional application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distal bone level	The variable was determined by measuring the distance from the CEJ of mandibular second molar to the highest point of the alveolar crest, performed with the periapical radiograph using the parallel technique, standardized with a film holder and a stent with a 5 mm steel segment	at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain was assessed by patient using the VAS (Visual Analog Scale) on the 1st, 3rd, 7th day after surgery. The VAS pain assessment scale is a 100 mm long line with 2 endpoints defined as "no pain" on the left side and "maximum pain" on the right side. The patient will record his/her pain level by marking a point on the line, the pain point will be the distance measured from the left endpoint to the point marked by patient.	on the 1st, 3rd, 7th day after surgery
Postoperative swelling	Facial swelling was assessed by the patient using the modified VAS scale of Pasqualini et al (2005) on the 1st, 3rd, 7th day after surgery. The scale consisted of 6 levels from 0 (no swelling) to 5 (severe swelling), patient will choose the corresponding level of swelling.	on the 1st, 3rd, 7th day after surgery
Soft tissue healing	Soft tissue healing was assessed using Healing index of Landry, Turnbull, and Howley on the 7th day after surgery. The scale consists of 5 grades, from grade 1 (very poor healing) to grade 5 (excellent healing) based on signs of tissue color, bleeding, presence of granulation tissue, presence of pus, and degree of epithelialization.	on the 7th day after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: August 6, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 3566/DHYD-HDDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No