NCT05668494

Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment

Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment in the Posterior Mandible Without Bone Augmentation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Belgrade · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be a prospective, randomized, controlled, single center clinical trial with 1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.

Detailed description

Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples. Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR). Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated. Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.

Conditions

• Bone Loss in Jaw

Interventions

Type	Name	Description
OTHER	immediate loading of implants	This is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-12-29
• Last updated: 2022-12-29

Locations

1 site across 1 country: Serbia