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Efficacy and safety of locally produced polycaprolactone infiltrated porous nanohydroxyapatite and bilayered polycaprolactone membrane for bone augmentation in dental implant treatment

Efficacy and safety of locally produced polycaprolactone infiltrated porous nanohydroxyapatite and bilayered polycaprolactone membrane for bone augmentation in dental implant treatment: A Multicenter prospective single-blinded randomized controlled clinical study

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230601004
Enrollment
64
Registered
2023-06-01
Start date
2023-07-03
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

Patients who needed a single-unit implant restoration with GBR of bony defects. Dental implants Hydroxyapatite Polycaprolactone

Interventions

Commercial bovine bone graft + Commercial Collagen Membrane,Commercial bovine bone graft+Bilayered polycaprolactone membrane ,Polycaprolactone infiltrated porous nanohydroxyapatite bone graft + Commer
Commercial bone graft+Commercial Membrane,Commercial bovine bone graft+Bilayered polycaprolactone membrane ,Polycaprolactone infiltrated porous nanohydroxyapatite bone graft + Commercial Collagen Memb

Sponsors

Health Systems Research Institute (HSRI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (age 20-65 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 are including: a. Alveolar bone defects, class 2. b. The edentulous area allows placement of at least one standard implant and not exceeded a two-tooth span. 4. Patients who needed reconstruction of the edentulous sites with simultaneous implant placement 5. Controlled periodontitis. 6. Smoking history less than 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 of the materials to be used in the study.

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 with active infection or pathologic lesions prior to operation 4. Patients who cannot take impression (both conventional and digital) and CBCT 5. History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years. 6. History of autoimmune disease or long-term prescribed of nonsteroidal antiinflammatory drugs 7. Unwillingness to return for the follow-up examination.

Design outcomes

Primary

MeasureTime frame
Wound healing 2 weeks, 1 month, and 3 months after the surgery. The healing index (HI),Implant stability 3 months, definitive restoration,6 months after surgery Radio Frequency Analysis

Secondary

MeasureTime frame
Quality of Life Before surgery, 6 months after surgery Questionaire

Countries

Thailand

Contacts

Public ContactJintamai Suwanprateeb

National Metal and Materials Technology Center

jintamai@mtec.or.th025646500

Outcome results

None listed

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