Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment

NCT05668494 | Unknown

• 1 other identifier: One abutment one time study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, randomized, controlled, single center clinical trial with 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.

Conditions

Bone Loss in Jaw

Outcome Measures

Primary Outcomes (1)

• Periimplant marginal bone loss

  Hard tissue changes will be analyzed and followed up at 3, 6 and 12 months by captured intraoral radiographs using a customized radiographic holder. The following landmarks will be measured in order to assess bone remodelling around implants * Mesial distance in mm from first bone to implant contact to implant shoulder (vertical line); * Distal distance in mm from first bone to implant contact to implant shoulder (vertical line) after implant placement.

  12 months

Study Arms (1)

immediate loading

OTHER

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

Other: immediate loading of implants

Interventions

immediate loading of implants OTHER

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

immediate loading

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Minimum age of 25 years
• 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.

You may not qualify if:

• Medical condition that contraindicates surgery: ASA -score ≥ III
• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental Medicine University of Belgrade

Belgrade, 11000, Serbia

Location

Study Officials

• Ana R Todorovic, DDS,PhD

  School of Dentistry, University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 29, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

SE (1)