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NCT05838365 Clinical Trial

Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05838365
Other study ID # 74/22
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2022
Est. completion date June 1, 2029

Study information
Verified date April 2023
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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:

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date June 1, 2029
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Local exclusion criteria: - untreated stage III/IV periodontitis - Autoimmune diseases - oral parafunctions

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy San Paolo Hospital Milano

Sponsors (1)
Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implant success rate according to Buser's criteria presence of subjective complaints related to the area of treatment; recurrent infections in the peri-implant region accompanied by suppuration; mobility of the implant fixture 5 years
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