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Recruiting NCT07114523

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

No phase Interventional Periodontal Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: collagen membrane, third molar surgery.
Who it may be relevant to
Registry conditions: Periodontal Defect. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Procedure collagen membrane
    collagen membrane apply to distal surface of second molar after third molar surgery
  • Procedure third molar surgery
    standard third molar surgery without any additional application

Primary outcome measures

  • Distal periodontal tissue status [Time frame: preoperative (T0), 3rd moth after surgery (T3) and 6th month after surgery (T6)]
Secondary outcome measures (1)
  • Distal bone level [Time frame: at the time of the end of surgery (T0'), 3rd month after surgery (T3), and 6th month after surgery (T6).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • University of Medicine and Pharmacy at Ho Chi Minh city — Ho Chi Minh City

Identifiers

NCT: NCT07114523 · 3566/DHYD-HDDD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗