Influence of the Primary Stability and Temporary Prosthetics

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTomas Linkevicius

About this trial

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.

Eligibility criteria

Qualifiers

≥ 18 years old.

healthy patients without medical contraindications for dental implantation surgery.

removable and non-molar teeth indicated for extraction in both jaws

healthy soft tissues (bleeding on probing < 20%, plaque index < 25%);

Disqualifiers

Smokers (≥ 10 cigarettes per day);

history of uncontrolled periodontitis;

uncontrolled diabetes/alcoholism;

use of drugs that may affect healing;

Trial design

Treatments tested in this trial

  • Implant placement
  • Healing abutment
  • Temporary crown
  • Bone grafting of the implant
  • Non-resorbable membrane

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Tomas Linkevicius

Lead sponsor

Lithuanian University of Health Sciences

Sponsor institution

Lithuanian University of Health Sciences

Collaborator