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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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study

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

Group Type EXPERIMENTAL

collagen membrane

Intervention Type PROCEDURE

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

control

standard third molar surgery without any application

Group Type ACTIVE_COMPARATOR

third molar surgery

Intervention Type PROCEDURE

standard third molar surgery without any additional application

Interventions

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collagen membrane

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

Intervention Type PROCEDURE

third molar surgery

standard third molar surgery without any additional application

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No