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

N/ANot Yet RecruitingNCT07417293

Universitat Internacional de Catalunya35 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Posterior Atrophic Maxilla

Interventions

Ultra short implantsDEVICE

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

Long implants with bone augmentationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: The day of the intervention after the surgery is finalized

Secondary Outcomes

Surgical time

elapsed time since the administration of local anesthesia until the placement of the last suture knot, with a scale of the exact minutes

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

Pain Intensity

Subjective assessment of pain intensity using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain

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

The need to intake rescue medication of Ibuprofen 600mg, Paracetamol 650mg or Amoxicilin 500mg with a nominal response of Yes or No

Time frame: After the surgery during the next 7 days

Intra-surgical complications

Any undesired event that happens during the surgical procedure, for example, profuse bleeding, Schneider membrane perforation, by a categorical nominal answer Yes or No

Time frame: The day of the surgery

Data from ClinicalTrials.gov

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