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

NCT07417293 | Not Yet Recruiting FDA Device

• 1 other identifier: PER-ECL-2024-07
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Posterior Atrophic Maxilla

Outcome Measures

Primary Outcomes (1)

• Satisfaction of the surgical procedure

  The patient is gonna make a subjective assessment of satisfaction of the surgery once it is finished. For that, we are going to use a 10 centimeter visual analog scale. The extremes of the scale are the extreme expressions of satisfaction, where the extreme left represents a 0 (not satisfied) and 10 (very satisfied). The patient won't have numbers between 0-10 so he will not be influenced by them. Wherever he marks, we will measure it and it will represent in centimeters how was his satisfaction

  The day of the intervention after the surgery is finalized

Secondary Outcomes (13)

• Surgical time

  at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot

• Pain Intensity

  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

  After the surgery during the next 7 days

• Intra-surgical complications

  The day of the surgery

• Post-surgical complications

  7 days after the surgery

Other Outcomes (10)

• Age

  The day of the inform consent and selection period and 7 days after the surgery

• Gender

  The day of the inform consent and selection period

• Smoking habit

  The day of inform consent and selection period

Study Arms (2)

ultra-short implants

EXPERIMENTAL

4mm long implants

Device: Ultra short implants

long implants with bone augmentation

OTHER

8mm long implants after transcrestal sinus floor elevation with bone augmentation

Device: Long implants with bone augmentation

Interventions

Ultra short implants DEVICE

Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure

ultra-short implants

Long implants with bone augmentation DEVICE

Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation

long implants with bone augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 18, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-01