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NCT Number: NCT07374757

Immediately Loaded Implants With or Without Horizontal Augmentation

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

guided bone regeneration technique

Procedure

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.

No intervention

Procedure

Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.

Primary outcomes

  1. Implant Success Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Clinical Outcomes of Immediately Loaded Implants With Buccal Dehiscence Treated by Horizontal Augmentation Compared With Immediately Loaded Implants Without Regeneration Techniques

Acronym: ILHA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.