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

Sponsor

University of Belgrade (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05668494

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss in Jaw	Other: immediate loading of implants	N/A

Detailed Description

Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Immediate Loading With Provisional Prosthetic Restoration by Means of One Abutment at One Time and Temporary Abutment in the Posterior Mandible Without Bone Augmentation

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

Periimplant marginal bone loss [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dental Medicine University of Belgrade	Belgrad		Serbia	11000

Sponsors and Collaborators

University of Belgrade

Investigators

Principal Investigator: Ana R Todorovic, DDS,PhD, School of Dentistry, University of Belgrade

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ana Todorovic, Principal Investigator, University of Belgrade

ClinicalTrials.gov Identifier:

NCT05668494

Other Study ID Numbers:

One abutment one time study

First Posted:

Dec 29, 2022

Last Update Posted:

Dec 29, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 29, 2022