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Subcrestal vs Juxtacrestal PRAMA Implants With Variable Necks

NCT07107464 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-06

No results posted yet for this study

Summary

The goal of this clinical trial is to understand how different implant neck designs and placement depths affect the surrounding bone and peri-implant tissue (the tissue around a dental implant) in adults who need implants in the back areas of the mouth (molars and premolars). The main questions it aims to answer are:

Does placing implants deeper under the bone crest (subcrestally) help preserve more bone and peri-implant tissue over time? Do implants with longer, conical necks and micro-threaded surfaces result in more stable peri-implant tissue than implants with shorter necks? Researchers will compare three types of one-piece dental implants with different neck heights (short, standard, and long), placed at different depths in the jawbone, to determine which combination better maintains bone and peri-implant tissue levels.

Participants will:

Receive two dental implants in the posterior upper or lower jaw Be randomly assigned to one of three groups depending on implant neck design and placement depth Undergo implant surgery using a digital workflow, with healing over three months Be rehabilitated with custom zirconia bridges Return for regular clinical and imaging checkups over a period of at least 3 years This study aims to generate evidence that helps clinicians choose implant designs and techniques that promote long-term peri-implant tissue health.

Conditions

  • Edentulism
  • Dental Implantation, Endosseous
  • Marginal Bone Loss
  • Periimplant Bone Loss

Interventions

DEVICE

Short Neck Implant - Crestal Placement

A one-piece endosseous dental implant with a 1.8 mm short convergent neck, placed at the bone crest. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface treatment.

DEVICE

Standard Neck Implant - 1 mm Subcrestal Placement

A one-piece endosseous dental implant with a standard-length neck (2.8 mm total; 0.8 mm cylindrical + 2 mm convergent), placed 1 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface.

DEVICE

Long Neck Implant - 2 mm Subcrestal Placement

A one-piece endosseous dental implant with a long transmucosal neck (3.8 mm total; 0.8 mm cylindrical + 3 mm convergent), placed 2 mm subcrestally. Implant used: PRAMA implant (Sweden \& Martina, Italy) with UTM surface.

Sponsors & Collaborators

  • ARDEC Academy

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-06-30
Completion
2026-07-01

Countries

  • Cuba

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 NCT07107464 on ClinicalTrials.gov