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Peri-implant Tissues Changes for Different Abutment Shapes and Heights

NCT07509281 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-03

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation.

The main questions it aims to answer are:

* Is there any difference in marginal bone loss for different abutment shapes and heights?
* Do the shape and height of the abutment affect implant success?

All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients:

1. 2-mm high abutments with cylindrical shape.
2. 2-mm high abutments with concave shape.
3. 3-mm high abutments with cylindrical shape.
4. 3-mm high abutments with concave shape.

Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.

Conditions

  • Dental Implant-Abutment Designs
  • Marginal Bone Loss in Different Abutment Designs
  • Soft Tissue Management in Subcrestal Dental Implants

Interventions

PROCEDURE

Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol

Participants will receive bone-level dental implants placed approximately 2 mm below the bone crest in a healed posterior site of the maxilla or mandible. The implants will be placed using biological drilling protocol and inserted with a final torque of at least 35 Ncm following the manufacturer's instructions . A transmucosal abutment according to the applicable randomization will be connected at the time of surgery with a final torque of at least 30 Ncm, following the "one abutment-one time" philosophy in order to avoid any changes in hard and soft peri-implant tissues.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Principal Investigators

  • María I Suárez Antoima, DDS, MSc · Universitat de València

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-07-31
Completion
2027-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509281 on ClinicalTrials.gov