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

Bone Loss in Jaw Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05668494
• Other study ID #: One abutment one time study
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2022
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss in Jaw

Intervention

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

Locations

Country	Name	City	State
Serbia	School of Dental Medicine University of Belgrade	Belgrad

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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