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COMPLETED
NCT07709676
NA

Beta-Tricalcium Phosphate Grafting of Peri-implant Jumping Gaps Greater Than 2 mm in Immediate Implants

Sponsor: Minia University

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.

Official title: Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-12-01

Completion Date

2025-11-01

Last Updated

2026-07-16

Healthy Volunteers

Yes

Interventions

DEVICE

Experimental: Test: beta-tricalcium phosphate grafting

A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th

Locations (1)

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

Ismailia, Egypt