Influence of the Primary Stability and Temporary Prosthetics

Summary

The goal of this clinical trial is to to determine how different primary implant stability and loading management affect implant osseointegration and further function after one year. The main questions it aims to answer are: is primary stability of inserted implant needed for implant integration? Does primary stability and restoration mode of the implant influence marginal bone stability of that implant? Researchers will compare crestal bone levels and primary stability of the implant after insertion in 3 groups. Subjects will be assigned to groups, acoording to primary stability developed during insertion of the implant. Study groups - (1) If stability is low (5-10 N/cm), Megagen BlueDiamond implants will be inserted, and a temporary prosthesis will not be placed; the implant will be sutured; (2) If stability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed; (3) If stability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed. Primary outcome of the study will be implant integration, secondary ourtcomes - implant insertion depth during insertion and after osseointegration, marginal bone stability after prosthesis delivery and after one year, determination of the PES (pink esthetic score) index after prosthesis delivery and after 1 year, determination of the ISQ value after implant insertion and after osseointegration, changes in gingival volume around the implants after 1 year, determination of the Plaque Index (PI) after prosthesis delivery and after 1 year, determination of the Probing Pocket Depth (PPD) after prosthesis delivery and after 1 year, determination of the Bleeding on Probing (BOP) index after prosthesis delivery and after 1 year.

Conditions

• Immediate Dental Implant Placement
• Immediate Dental Implant Loading
• Marginal Bone Levels

Interventions

PROCEDURE

Implant placement

After tooth extraction, dental implant is placed

PROCEDURE

Healing abutment

Composite healing abutment is formed chairside after implant placement and abutment is attcahed to the implant

PROCEDURE

Temporary crown

Prefabricated temporary crown is attcahed to the implant after implant placement

PROCEDURE

Bone grafting of the implant

After implant placement, bone graft is applied to extraction socket

PROCEDURE

Non-resorbable membrane

Non-resorbable membrane is put on the implant to prevent loading

Sponsors & Collaborators

• Lithuanian University of Health Sciences

  collaborator OTHER

• Tomas Linkevicius

  lead OTHER

Principal Investigators

• Tomas Linkevicius, PhD, DDS · Lithuanian University of Health Sciences

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-07

Primary Completion

2027-10-16

Completion

2028-01-05