Immediately Loaded Implants With or Without Horizontal Augmentation (ILHA)

January 20, 2026 updated by: Universidad Complutense de Madrid

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Horizontal bone augmentation associate with immediate loading
Procedure: guided bone regeneration technique
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.
Other: Inmediate Loading without bone regeneration technique
Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.
Procedure: No intervention
Immediately loaded dental implants placed without the use of any bone regeneration or augmentation techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after implant placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 11, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCM2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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