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

September 16, 2026 updated by: Tan Chuey Chuan, University of Malaya

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry, Universiti Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCL membrane

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 after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar
Combination product: Extracellular matrix collagen (ECM) membrane

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
Active Comparator: ECM collagen membrane

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 after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar
Combination product: polycarprolactone membrane (PCL membrane)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal health assessment on lower second molar (1)
Time Frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

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.
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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.
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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.
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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)
baseline on day of surgery, 12 weeks and 24 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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.
radiograph taken prior to surgery and 24 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

Osteopore International

Investigators

  • Study Director: Wei Cheong Ngeow, PhD, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
  • Principal Investigator: Rou Enn Ng, BDS, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Aimetti, M., Romano, F., Pigella, E., Pranzini, F., & Debernaerdi, C. (2005). Treatment of Wide, Shallow, and Predominantly 1-Wall Intrabony Defects With a Bioabsorbable Membrane: A Randomized Controlled Clinical Trial. Journal of Periodontology, 76(8), 1354-1361. Bohner, M., Santoni, B. L. G., & Dobelin, N. (2020). Beta-tricalcium phosphate for bone substitution: Synthesis and properties. Acta Biomater, 113, 23-41. Canullo, L., Rossi-Fedele, G., Camodeca, F., Menini, M., & Pesce, P. (2021). A Pilot Retrospective Study on the Effect of Bone Grafting after Wisdom Teeth Extraction. Materials (Basel), 14(11https://doi.org/10.3390/ma14112844). Chen, G., Sato, T., Ohgushi, H., Ushida, T., Tateishi, T., & Tanaka, J. (2005). Culturing of skin fibroblasts in a thin PLGA-collagen hybrid mesh. Biomaterials, 26(15), 2559-2566. De Angelis, N., Pesce, P., Poedjiastoeti, W., Suwandi, T., Tjandrawinata, R., Bagnasco, F., & Menini, M. (2024). 3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study. Dent J (Basel), 12(10). Retrieved Oct 7, from https://www.ncbi.nlm.nih.gov/pubmed/39452449 Dodson, T. B. (2004). Management of Mandibular Third Molar Extraction Sites to Prevent Periodontal Defects. Journal of Oral and Maxillofacial Surgery, 62(10), 1213-1224. Fairbairn, P., Kilner, S., O'Hooley, D., Fish, A., & Kurtzman, G. M. (2023). Sinus Augmentation for Implant Placement Utilizing a Novel Synthetic Graft Material with Delayed Immediate Socket Grafting: A 2-Year Case Study. J. Clin. Med, 12(1). Goh, B. T., Teh, L. Y., Tan, D. B., Zhang, Z., & Teoh, S. H. (2015). Novel 3D polycaprolactone scaffold for ridge preservation--a pilot randomised controlled clinical trial. Clin Oral Implants Res, 26(3), 271-277. Retrieved Mar, from https://www.ncbi.nlm.nih.gov/pubmed/25263527 Jambhekar, S., Kernen, F., & Bidra, A. S. (2015). Clinical and histologic outcomes of socket grafting after flapless tooth extraction:

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DF OS 2512/0060 (P)
  • UMG057E-2025 (Other Grant/Funding Number: Universiti Internal Grant (DPRG))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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