Bone Augmentation Associated With Immediate Loading
Conditions
Keywords
Inmediate loading, horizontal bone regeneration
Brief summary
This study aims to compare the clinical success and patient-reported outcomes of immediately loaded dental implants placed in sites with buccal dehiscence treated by horizontal augmentation versus immediately loaded implants placed without regeneration techniques.
Detailed description
This is a prospective, interventional, non-randomized, comparative clinical trial designed to evaluate the clinical outcomes of immediately loaded dental implants using two different surgical approaches. One group will receive implants placed in sites with buccal dehiscence treated by horizontal bone augmentation, while the comparison group will receive immediately loaded implants placed without the use of any bone regeneration techniques. The primary outcome of the study is implant success at 12 months after implant placement. Secondary outcomes include marginal bone level changes, complication rates, and oral health-related quality of life assessed using a validated questionnaire. The study is conducted with a parallel assignment model and an open-label design due to the nature of the surgical interventions.
Interventions
Immediately loaded dental implants placed in sites presenting buccal dehiscence treated by horizontal bone augmentation using a guided bone regeneration technique according to a standardized surgical protocol.
Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.
Sponsors
Study design
Eligibility
Inclusion criteria
Adult patients requiring dental implant placement Presence of buccal dehiscence at the implant site Indication for immediate loading Ability to provide written informed consent
Exclusion criteria
Uncontrolled systemic diseases Active periodontal disease Heavy smoking exceeding predefined limits Conditions contraindicating oral surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success Rate | 12 months after implant placement | Implant success is defined as implant survival at 12 months, absence of clinical mobility, absence of persistent pain or infection, absence of peri-implant radiolucency, and no need for implant removal or surgical re-intervention. |