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Enrolling By Invitation
NCT05668494
Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment
Conditions: Bone Loss in Jaw
Sex: All
Ages: 25 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 24
Sponsor: University of Belgrade
Location: Serbia
Summary
This will be a prospective, randomized, controlled, single center clinical trial with1 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.
Eligibility Criteria
Inclusion Criteria:Minimum age of 25 yearsIn 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:Medical condition that contraindicates surgery: ASA -score ≥ IIIHistory 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.
Source: ClinicalTrials.gov (NCT05668494). StuddyBuddy aggregates publicly available trial information.