Clinical, Patient-Reported outcomes and Efficacy of Static Computer-Assisted Sinus Floor Augmentation: A Randomized Controlled Trial

Clinical, Patient-Reported outcomes and Efficacy of Static Computer-Assisted Sinus Floor Augmentation: A Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230427005

Enrollment

Registered

2023-04-27

Start date

2023-05-01

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

Patients who need for implant placement in posterior maxilla with residual alveolar bone height between 1-5 mm Surgical guide, Guided surgery, computer-assisted surgery, lateral window sinus floor elevation, sinus augmentation, patient-reported outcomes

Interventions

Placement the device to perform osteotomy outline into maxillary sinus ,Define osteotomy outline to maxillary sinus with conventional freehand

Experimental Device,No Intervention No treatment

surgical guide,freehand surgery

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Medically healthy adult (ASA I-II) and age more than 21 years old 2.Non-smoker or previous smoker (quit more than 5 years) or light smoker with less than 10 cigarettes/day 3.Edentulous spaces in posterior maxilla in 1 or 2 posterior quadrants with an alveolar bone defect which requires lateral approach sinus floor augmentation for 1-3 implant placement (residual crestal height less than 6 mm) 4.Absence of sinus membrane pathology or rhinosinusitis or other pathology requiring management

Exclusion criteria

Exclusion criteria: 1. Medically compromised subjects (ASA III-V) 2.General contraindications against implant treatment or augmentative procedures (immunodeficiency or advanced systemic diseases or corticosteroid medication) 3.Patients taking oral bisphosphonates longer than 5 years /anti-angiogenic/RANKL inhibitor medications or receiving local radiotherapy 4.Heavy smoker or previous heavy smoker (quit less than 5 years or more than 10 cigarettes/day) 5.Acute/Chronic unmanaged symptomatic sinusitis 6.Type 1 implant placement (immediate implant placement following extraction) 7.Need for simultaneous soft tissue augmentation. 8.Residual bone height more than 6 mm 9.Subjects aged less than 21 years old

Design outcomes

Primary

Measure	Time frame
Patient-reported Outcomes day1-7,14 after surgery Visual analog Scale Scores,Complications, surgical wound healing intraoperative , 2,4 weeks after surgery Dichotomic score,Duration of surgery Intraoperation Time	—

Secondary

Measure	Time frame
Operator's opinion Intraoperation Linkert scale	—

Countries

Thailand

Contacts

Public ContactNattakarn Narongchai

Faculty of Dentistry , Chulalongkorn University

n_wan39@hotmail.com0909896936

Outcome results

None listed

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