Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.

Phase 4Active Not RecruitingNCT07834645

University of Malaya18 enrolled

Overview

This study compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving PCL membrane and the other receiving ECM membrane after socket filled with EthOss (an alloplastic bone graft). Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays.

Surgical removal of impacted mandibular third molars (M3) often associated with post-operative morbidities such as pain, facial swelling, limited mouth opening and injuries to the inferior alveolar nerve or lingual nerve. In addition, it can result in compromised periodontal health of the adjacent second molar (M2) and reduced alveolar bone height at the M3 region. The defect can be restored using bone substitutes with membrane. This study aims to assess wound healing of the surgical sites of third molar surgery with application of alloplastic bone graft with PCL membrane and ECM-collagen membrane. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket covered with PCL membrane and ECM-collagen membrane after filled up EthOss® alloplastic graft. The participants will be reviewed at post-operative 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) to monitor for signs of graft reaction/rejection. Periodontal assessments were performed at these four visits to assess the soft tissue healing. Radiological assessment (intraoral periapical x-ray) will be done at preoperative and post-operative week 24 to assess bone depth.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Interventions

polycarprolactone membrane (PCL membrane)COMBINATION_PRODUCT

This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast.

Extracellular matrix collagen (ECM) membraneCOMBINATION_PRODUCT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient who requires surgical removal of bilateral impacted M3. * Patient with impacted bilateral M3 which are sound. * Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification. * Presence of disease-free mandibular second molar (M2) adjacent to the M3 to be extracted * Patient aged 18 to 35 years old who are medically fit Exclusion Criteria: * Impacted M3 associated with: * Fracture of angle of mandible. * Radiological evidence of cyst or tumour. * Incomplete root formation. * Acute pulpitis or severe pericoronitis that is not under controlled. * Gross dental caries. * Retained roots of mandibular third molar with history of removal or coronectomy of unerupted/impacted M3. * Patients with periodontal disease * Patients with absence of lower second molars. * Medically compromised patients * Pregnant women. * Patient on oral contraceptives. * Current or previous bisphosphonate therapy or history of radiotherapy to the jaws. * Active smokers

Outcomes

Primary Outcomes

Periodontal health assessment on lower second molar (1)

1\. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health.