The clinical efficacy of Polycarpolactone impregnated 3D printed hydroxyapatite in maxillary sinus augmentation for dental implant therapy : A pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210622003

Enrollment

Registered

2021-06-22

Start date

2021-07-01

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 (Age 18-70 years), Good general health (ASA 1, 2) and not a contraindication for minor surgery, The diagnosis and indications for lateral maxillary sinus augmentation are including Polycarpolactone, 3D printed hydroxyapatite, maxillary sinus augmentation

Interventions

Polycarpolactone impregnated 3D printed hydroxyapatite from the National Metal and Materials Technology Center (MTEC),Xenograft bovine bone

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

Polycarpolactone impregnated 3D printed hydroxyapatite,Xenograft straumann

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (age 18-70 years) 2. Good general health (ASA 1, 2) and not a contraindication for minor surgery 3. The diagnosis and indications for lateral maxillary sinus augmentation with residual alveolar ridge less than or equal 4 mm 4. The edentulous area allows placement for single unit dental implant or multiple unit dental implant. 5. Patients who needed reconstruction of the edentulous sites with simultaneous implant placement 6. Controlled periodontitis. 7. No history of allergy or hypersensitivity to any of the 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/immunosuppressive agents . 2. Presence of acute inflammation, infection or pathology in the maxillary sinus prior to operation 3.Pregnancy or lactation. 4. Patients who have poor oral hygiene. 5.Smoking history > 10 cigarettes per day 6.Patients who cannot take impression (both conventional and digital) and CBCT 7. History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years. 8. History of autoimmune disease or long-term prescribed of nonsteroidal anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame
clinical efficacy of Polycarpolactone impregnated 3D printed hydroxyapatite in maxillary sinus augmentation 6 months clinical, radiographic(CBCT and micro CT), histomorphometry	—

Secondary

Measure	Time frame
implant stability 3 months ISQ	—

Countries

Thailand

Contacts

Public ContactPoommarin Thammanoonkul

Faculty of Dentistry, Thammasat University

pumarin87@gmail.com0865461998

Outcome results

None listed

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