Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

University of Milan

Status and phase: Enrolling; Phase 4

Conditions: Dental Implant Failed; Peri-implant Mucositis; Peri-Implantitis

Treatments: Device: Zirconia implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05838365

74/22

Details and patient eligibility

About

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:

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Immediate loading zirconia implant

Experimental group

Description:

Loading of zirconia dental implant within 7 days after implant placement

Treatment:

Device: Zirconia implant

Delayed loading zirconia implant

Active Comparator group

Description:

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

Treatment:

Device: Zirconia implant