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Not yet recruiting NCT07417293

Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw

No phase Interventional Posterior Atrophic Maxilla

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultra short implants, Long implants with bone augmentation.
Who it may be relevant to
Registry conditions: Posterior Atrophic Maxilla. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical- and Patient-related Outcomes of 4 mm Ultra-short Implants Compared to 8 Mm-long Implants With Bone Augmentation for the Rehabilitation of Posterior Atrophic Maxilla: a Randomized Controlled Clinical Trial.

Overview

This study aims to compare 2 different groups of patients with both a healed site in the upper posterior sector after extractions, one treated with ultra-short implants, and another with long implants with bone regeneration. The objective is to evaluate if short-implants are superior in terms of better clinical outcomes, survival rates and safety, reduced surgical time, postoperative discomfort, and complication risk compared to conventional implants and bone regeneration.

Interventions

  • Device Ultra short implants
    Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure
  • Device Long implants with bone augmentation
    Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation

Primary outcome measures

  • Satisfaction of the surgical procedure [Time frame: The day of the intervention after the surgery is finalized]
Secondary outcome measures (12)
  • Surgical time [Time frame: at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot]
  • Pain Intensity [Time frame: Since the day of the intervention once the surgery is finalized , until the 7th day after the surgery, each day of the following 7 days]
  • Rescue medication [Time frame: After the surgery during the next 7 days]
  • Intra-surgical complications [Time frame: The day of the surgery]
  • Post-surgical complications [Time frame: 7 days after the surgery]
  • Implant survival [Time frame: From 10 weeks after surgery to 36 months, after restoration delivery]
  • Marginal bone level changes [Time frame: The day of the surgery, 12 months after and 36 months after]
  • Probing pocket depth [Time frame: 12 months after surgery and 36 months after surgery]
  • Bleeding on probing [Time frame: 12 months and 36 months after surgery]
  • Suppuration on probing [Time frame: 12 months and 36 months after surgery]
  • Keratinized mucosa width [Time frame: 12 months and 36 months after surgery]
  • Soft tissue dehiscence [Time frame: 12 months and 36 months after surgery]

Eligibility criteria

Inclusion criteria

  • Inform consent signed.
  • Adult patients (≥18 years old).
  • No pregnant women or without the desire to stay.
  • Periodontal and peri-implant health in a pristine or reduced periodontium.
  • Full mouth plaque score < 20% (O'Leary, 1972)
  • Maxillary multiple posterior maxillary healed sites at least 4 months after extraction (with antagonist teeth with a good prognosis (Lindhe et al. 2008)) presenting ≥ 6.5 mm of bone width and 5-6 mm in height from the bone crest to the floor of the sinus.
  • Need for a multiple splinted implant supported restoration with distal adjacent teeth or distal free-end in the posterior maxilla

Exclusion criteria

  • Patients with uncontrolled systemic diseases.
  • Smoker patients (≥10 cig/day).
  • Patients taking medications that affect bone metabolism or immunologic disorders.
  • Patients allergic to penicillin.
  • Patients presenting acute or chronic maxillary sinus lesions.
  • Advanced vertical crestal bone atrophy in the posterior maxilla (Type V and IV, Cawood-Howell Classification)
  • Vertical space of < 6 mm for a screw-retained implant restoration.
  • Patients referring allergy to titanium or to any component of the implant/restoration.
  • No previous attempts of implant installation in the same surgical site.
  • Pregnant or lactating women.
  • Patients willing to start or in course of an orthodontic therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07417293 · PER-ECL-2024-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗