RecruitingPhase 4NCT05838365

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants: A Multicenter Randomized Controlled Clinical Trial


Sponsor

University of Milan

Enrollment

220 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The main aim of the present study is to investigate implant success rate after 5 years of function of immediate (Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement) loading of two-pieces zirconia implant, placed in pristine bone without bone regeneration. Implant success rate will be defined according to Buser's criteria. Secondary endpoints: Marginal bone level (MBL) evaluation by means of standardized radiographs; Clinical evaluation of biological (e.g. Plaque Index, PI; Probing Pocket Depth, PPD, Bleeding on Probing, BOP; suppuration upon probing/palpation) and prosthetic/technical complications; Clinical evaluation of soft tissue width, keratinized tissue, marginal and interproximal soft tissue recession; Patient reported outcome measures (PROMs) by questionnaire administration:


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial compares two loading protocols — immediate loading (placing the crown on an implant the same day as surgery) versus delayed loading (waiting weeks for osseointegration before placing the crown) — for single zirconia dental implants placed in the premolar or molar positions. Zirconia implants are metal-free alternatives to traditional titanium implants, appealing to patients with metal sensitivities or those who prefer ceramic materials. Immediate loading saves the patient from wearing a temporary prosthesis and reduces the number of clinical appointments required. Systemically healthy adults with partial tooth loss in the premolar or molar regions, adequate bone dimensions, and at least 1 mm of keratinized gum tissue at the implant site are eligible. Those who smoke more than 10 cigarettes daily, have serious kidney or liver disease, uncontrolled diabetes, have taken bisphosphonate medications, have had head and neck radiation, are on chemotherapy, are immunocompromised, are pregnant, have connective tissue disorders, or have severe untreated gum disease are excluded. Zirconia implants represent the frontier of esthetic and biocompatible dental restoration, but questions remain about whether they can be loaded immediately without compromising osseointegration (how well the implant fuses with the bone). If immediate loading proves equally successful as delayed loading, patients could leave surgery the same day with a functional tooth — transforming the patient experience and potentially increasing implant uptake.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZirconia implant

(Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement)


Locations(1)

San Paolo Hospital

Milan, Italy

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NCT05838365


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