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The outcomes of using Biphasic Calcium Phosphate for bone augmentation in implant dentistry: Two randomized controlled clinical trials

The outcomes of using Biphasic Calcium Phosphate for bone augmentation in implant dentistry: Two randomized controlled clinical trials

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201109003
Enrollment
26
Registered
2020-11-09
Start date
2020-12-01
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

The outcomes of Biphasic Calcium Phosphate for bone augmentation 1) in conjunction with dental implant placement in the anterior maxilla 2) for bone augmentation of the maxillary sinus Biphasic Calcium Phosphate Dental implant The stability of contour augmentation Facial bone thickness Guided bone regeneration Sinus augmentation Bone biopsy Histological analysis Gene expression analysis

Interventions

This intervention included implant placement with simultaneous GBR in maxillary esthetic zone. The GBR procedure was performed using resorbable membrane with different composition of BCP between the s
Implant placement with simultaneous GBR,Sinus augmentation prior to implant placement

Sponsors

The 90th Anniversary of Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: For the first intervention arm (RCT): implant placement with simultaneous GBR Inclusion criteria 1.Patients with age above 20 years old. 2.Patients in need of implant placement with GBR in the esthetic zone of maxilla. 3.Available for CBCT scan at 14 days and 6 months after implantation. 4.Available for clinical assessment at 1, 3, and 6 months after surgery. For the second intervention arm (RCT): sinus augmentation prior to implant placement Inclusion criteria 1.Patients with age above 20 years old. 2.Patients with an insufficient bone height in the upper posterior edentulous area including second premolar, first molar and second molar and in need of sinus augmentation using BCP or xenograft by lateral approach for at least 6 months prior to implant placement. 3.Accessibility for bone biopsy of augmented sinus area during the implant surgery. 4. Primary stability achieved during implant placement.

Exclusion criteria

Exclusion criteria: 1.Patients with physical and/or psychological disability or/with a major difficulty in communication. 2.Patientswith history of malignancy, radiotherapy and/or chemotherapy for malignancy which related to implant area within the past 5 years.

Design outcomes

Primary

MeasureTime frame
The stability of contour augmentation (first intervention arm: RCT, implant placement with simultaneous GBR) At 2 weeks post-operation and 6 months later Horizontal bone dimensions (thickness) as measurement by CBCT ,The expression of osteogenic and osteoclastic activities (second intervention arm: RCT, sinus augmentation prior to implant placement) At least 6 months post-operation The relative change in gene expression of four target genes

Secondary

MeasureTime frame
Amount of newly formed bone and residual bone graft materials as measured by histology (second intervention arm: RCT, sinus augmentation prior to implant placement) At 6 months post-operation The percentage of newly formed bone and remaining graft material as measured in histological sections

Countries

Thailand

Contacts

Public ContactAtiphan Pimkhaokham

Faculty of Dentistry, Chulalongkorn University

atiphan.p@chula.ac.th0891308046

Outcome results

None listed

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