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

Phase 3

• Conditions: Patients who needed a single-unit implant restoration with GBR ofbony defects.; Dental implants; Hydroxyapatite; Polycaprolactone

• Registration Number: TCTR20230601004
• Lead Sponsor: Health Systems Research Institute (HSRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 19 August 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life Before surgery, 6 months after surgery Questionaire