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

Phase 3

Completed

• 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

• Registration Number: TCTR20201109003
• Lead Sponsor: The 90th Anniversary of Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Study Completion: 2022-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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