Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

Phase 4

Recruiting

• Conditions: Dental Implant Failed; Peri-implant Mucositis; Peri-Implantitis
• Interventions: Device: Zirconia implant

• Registration Number: NCT05838365
• Lead Sponsor: University of Milan

Brief 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:

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-05
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2024-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed loading zirconia implant	Zirconia implant	Loading of zirconia dental implants after at least 2 months of healing
Immediate loading zirconia implant	Zirconia implant	Loading of zirconia dental implant within 7 days after implant placement

Primary Outcome Measures

Name	Time	Method
Implant success rate according to Buser's criteria	5 years	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

Trial Locations

Locations (1)

San Paolo Hospital; 🇮🇹 Milano, Italy