NCT06693297

Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns

Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants. The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes. Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.

Detailed description

Study design: This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1. The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications. Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time. Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.

Conditions

• Dental Implant

Interventions

Type	Name	Description
DEVICE	Immediate loading of early placed implants	Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
DEVICE	Conventional loading of early placed implants	Definitive loading of early placed implants upon successful osteointegration (after 8 weks)

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: Jordan