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

NCT07834645 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: DF OS 2512/0060 (P)UMG057E-2025
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wisdom Tooth; Socket Preservation

Keywords

PCL membrane; ECM membrane; socket preservation

Outcome Measures

Primary Outcomes (5)

• 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.

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

• Periodontal health assessment on lower second molar (2)

  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)

  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)

  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)

  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 Outcomes (2)

• The width of keratinized tissue

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

• Bone gain at distal of lower second molar

  radiograph taken prior to surgery and 24 weeks after surgery

Study Arms (2)

PCL membrane

ACTIVE COMPARATOR

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

ECM collagen membrane

ACTIVE COMPARATOR

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)

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.

ECM collagen membrane

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.

Also known as: ECM membrane

PCL membrane

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• Osteopore International: collaborator

Study Sites (1)

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 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:

  BACKGROUND

Study Officials

• Wei Cheong Ngeow, PhD

  Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia

  STUDY DIRECTOR

• Rou Enn Ng, BDS

  Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

Model Details: This is a split mouth study, within a single patient with PCL membrane and ECM collagen membrane placed on each side of lower wisdom tooth socket after filled with allograft (Ethoss).

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 22, 2026
• Study Start: May 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)