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NCT Number: NCT07834645

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wisdom Tooth Socket Preservation

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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) 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.

Other names: ECM membrane

Primary outcomes

  1. Periodontal health assessment on lower second molar (1)

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    • 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.

  2. Periodontal health assessment on lower second molar (2)

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health

  3. Periodontal health assessment on lower second molar (3)

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while >5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health.

  4. Periodontal health assessment on lower second molar (4)

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.

  5. Periodontal health assessment on lower second molar (5)

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    The healing index of Landry (Grade 1 poor to Grade 5 excellent)

Secondary outcomes

  1. The width of keratinized tissue

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    The width of the keratinized gingiva will also be measured buccolingual at 6mm distal to the M2.

  2. Bone gain at distal of lower second molar

    Time frame: radiograph taken prior to surgery and 24 weeks after surgery

    The radiographic bone level will be measured at T0 and T4 as the distance between the distal point of a line passing through the cemento-enamel junction of M2 (mesial and distal projection of M2's CEJ) and the bone peak distal to M2, at the bottom of the bony defect Measurement in milimeter.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Osteopore International

Registry information

Official study title

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

Acronym: PCL ECM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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