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

Phase 2

• 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

• Registration Number: TCTR20210622003
• Lead Sponsor: Faculty of Dentistry, Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-22
• Study Completion: 2022-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
implant stability 3 months ISQ