Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

NCT ID: NCT05838365

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2029-06-01

Brief Summary

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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:

Detailed Description

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Conditions

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Dental Implant Failed Peri-implant Mucositis Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate loading zirconia implant

Loading of zirconia dental implant within 7 days after implant placement

Group Type EXPERIMENTAL

Zirconia implant

Intervention Type DEVICE

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

Delayed loading zirconia implant

Loading of zirconia dental implants after at least 2 months of healing

Group Type ACTIVE_COMPARATOR

Zirconia implant

Intervention Type DEVICE

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

Interventions

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Zirconia implant

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sistemically healthy patients
* partial edentulism
* premolar position
* molar position
* Bone width and height at least 6 and 10mm, respectively.
* Keratinized tissue, at least 1 mm at implant site
* Full understanding of the proposed surgical treatments and the protocol schedule
* Full comprehension and availability to sign the informed consent form

Exclusion Criteria

* Heavy smokers (\>10 cigarettes a day)
* Serious kidney or liver diseases
* Uncontrolled diabetes
* Bisphosphonates intake
* History of radiotherapy of the head and neck
* Current antiblastic chemotherapy
* Congenital (primary) or acquired (secondary) immunodeficiency
* Pregnant women
* Connective tissue disorders


* untreated stage III/IV periodontitis
* Autoimmune diseases
* oral parafunctions
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Antonino Palazzolo

Dr. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Paolo Hospital

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eugenio Romeo, Full Professor

Role: primary

+39 0250319039

Other Identifiers

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74/22

Identifier Type: -

Identifier Source: org_study_id

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