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RecruitingNCT07114523Updated Aug 11, 2025

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

An interventional study of collagen membrane and third molar surgery in Periodontal Defect, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2024, registered Jul 2025).
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Periodontal Defect
03

In context

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    study

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

    Procedure: collagen membrane

  • Active comparator
    control

    standard third molar surgery without any application

    Procedure: third molar surgery

Interventions

  • Procedurecollagen membrane

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

  • Procedurethird molar surgery

    standard third molar surgery without any additional application

06

What researchers measure

Primary outcomes

  1. Distal periodontal tissue status

    distal periodontal tissue status was assessed using variables of pocket depth

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

Secondary outcomes

  1. 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

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

Other outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

    Time frame: on the 7th day after surgery

07

Study locations

1 of 1 sites recruiting
  • University of Medicine and Pharmacy at Ho Chi Minh city
    Ho Chi Minh City, Vietnam
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07114523
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible party
Lam Cu Phong (lecturer, clinical professor, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Aug 11, 2025
Start date
Dec 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Aug 11, 2025

Study contacts

Phong Cu Lam, MD.DDS
Contact
lamcuphong@ump.edu.vn
+84932114888

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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