Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment
NCT ID: NCT05668494
Last Updated: 2022-12-29
Study Results
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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UNKNOWN
NA
24 participants
INTERVENTIONAL
2022-09-01
2024-09-01
Brief Summary
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1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.
Detailed Description
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Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR).
Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated.
Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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immediate loading
Immediate loading of implants by means of one definitive abutment on one side and temporary abutment on the other side of the posterior mandible restored by provisional crown-split mouth design
immediate loading of implants
This is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol
Interventions
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immediate loading of implants
This is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol
Eligibility Criteria
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Inclusion Criteria
* In need of a one or two implants.
* Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue , with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant with a minimal diameter of 3.5 mm).
* Mandible second premolar or molar region.
* At least one neighboring tooth to be present.
* Absence of visible active periapical or periodontal inflammation.
* Adequate oral hygiene: PI\< 20%, BoP\< 20%.
* Sufficient occlusal units mesial or distal and antagonizing, including the diastema to be restored: 4 occlusal units.
Exclusion Criteria
* History of radiotherapy in the head and neck region.
* History of Bisphosphonate medication.
* Medium smokers ≥ 10 cigarettes per day.
* Patients unwilling or incapable of understanding and signing the informed consent.
* Active caries.
* Presence of inflammation expressed by PPD \>4mm and BoP on adjacent teeth.
* Active periapical radiolucency or root canal treatment performed \< 4 months previous to planned implant insertion on a neighboring tooth to future implant.
* Insufficient restorative space.
* Interocclusal plane distance \< 20mm at planed implant position.
25 Years
50 Years
ALL
Yes
Sponsors
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University of Belgrade
OTHER
Responsible Party
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Ana Todorovic
Principal Investigator
Principal Investigators
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Ana R Todorovic, DDS,PhD
Role: PRINCIPAL_INVESTIGATOR
School of Dentistry, University of Belgrade
Locations
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School of Dental Medicine University of Belgrade
Belgrade, , Serbia
Countries
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Other Identifiers
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One abutment one time study
Identifier Type: -
Identifier Source: org_study_id