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Clinical efficacy of polycaprolactone membrane for bone augmentation in dental implant treatment: Pilot study

Clinical efficacy of polycaprolactone membrane for bone augmentation in dental implant treatment: Pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200526010
Enrollment
24
Registered
2020-05-26
Start date
2020-05-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients (Aged 20-65 years) Good general health (ASA 1, 2) and not a contraindication for minor surgery The diagnosis and indications for guided bone regeneration Dental implants, Guided bone regeneration

Interventions

Synthetic resorbable membrane,Collagen membrane
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Polycaprolactone membrane,Cytoplast RTM

Sponsors

Faculty of Dentistry, Thammasat University
Lead Sponsor
Faculty of Dentistry&#44
Collaborator
Thammasat University
Collaborator

Eligibility

Sex/Gender
Male
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (age 20-70 years) 2. Good general health (ASA 1, 2) and not a contraindication for minor surgery 3. The diagnosis and indications for a particulate bone substitute include: a. Alveolar bone defects, class 2 (Benic & Hammerle 2014). b. The edentulous area allows placement of at least one standard implant and not exceed a two-tooth span. 4. Patients who needed reconstruction of the edentulous sites with simultaneous implant placement 5. Controlled periodontitis. 6. Smoking history <10 cigarettes per day. For the subject who smokes but less than 10 cigarettes per day is requested to stop smoking two weeks before and after bone block graft surgery and implant placement 7. No history of allergy or hypersensitivity to any materials to be used in the study. 8. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of relevant medical conditions: Patients with bone disease, osteoporosis, uncontrolled diabetes mellitus, unstable or life-threatening conditions, or requiring antibiotic prophylaxis. Patients with medication of drugs influencing the bone metabolism or use of bisphosphonates. 2. Pregnancy or lactation. 3. Patients who have poor oral hygiene. 4. Patients with active infection or pathologic lesions prior to operation 5. Patients who cannot take impression (both conventional and digital) and CBCT 6. History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years. 7. History of autoimmune disease or long-term prescribed of nonsteroidal anti-inflammatory drugs 8. Unwillingness to return for the follow-up examination.

Design outcomes

Primary

MeasureTime frame
Bone thickness and soft tissue dimensional change 1 year after loading Clinical,Radiogragphic

Secondary

MeasureTime frame
Clinical parameters, marginal bone level, Implant stability, wound healing, esthetic score 1 year after loading Radiographic

Countries

Thailand

Contacts

Public ContactThun Kusirisin

Faculty of Dentistry, Thammasat University

thun.ku@hotmail.com0817248400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026