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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Parallel
Treatments tested in this trial
Implant placement
Procedure/SurgeryAfter tooth extraction, dental implant is placed
Healing abutment
Procedure/SurgeryComposite healing abutment is formed chairside after implant placement and abutment is attcahed to the implant
Temporary crown
Procedure/SurgeryPrefabricated temporary crown is attcahed to the implant after implant placement
Bone grafting of the implant
Procedure/SurgeryAfter implant placement, bone graft is applied to extraction socket
Non-resorbable membrane
Procedure/SurgeryNon-resorbable membrane is put on the implant to prevent loading
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 5-10 N/cmExperimental treatment 3 interventions
Group B: 15-35 N/cmExperimental treatment 3 interventions
Group C: 40 N/cm and moreExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Implant oseointegration
Implant will be considered integrated if implant will meet criteria (Buser et al, 1990) •. The implant is in its original position. * There are no persistent complaints. * There is no peri-implant inflammation. * There is no implant loosening. * There is no peri-implant radiolucency.
Time frame
After 4 months post-insertionSecondary outcomes
1
Implant insertion depth
Implant insertion depth from free gingival margin till the neck of the implant will be measured in mm with 0.5 mm graded periodontal probe after implant insertion and 4 months after implant osseointegrartion
Time frame
After implant placement and after 4 months post-healing2
Marginal bone loss
Marginal bone loss will be measured in mm on radiographic images, which will be calibrated.Marginal bone loss around the implant was assessed by measuring the distance from the implant-abutment junction to the initial point of bone contact on both the mesial and distal sides, and an average was determined for each implant.
Time frame
After delivery of implant restoration and after 1 y follow-up3
PES (pink esthetic score) index
The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinically according to seven variables scored from 0→2: 1. Mesial papilla 2. Distal papilla, 3. Keratinized gingiva, 4. Curvature of the gingival margin, 5. Level of the gingival margin, 6. Root convexity 7. Scar formation. The bigger ther score - better. Maximum points - 14
Time frame
After prosthesis delivery and after 1 year4
Implant stability quotient (ISQ) value
Primary Implant stability was determined using resonance freaquency analyzer (RFA) in both the buccolingual and mesiodistal direction and an average value is noted down. RFA calculates value in terms of ISQ (Implant Stability Quotient) ranging from 0-100. ISQ value was measured for each implant at the baseline followed by just before the final restoration.
Time frame
After implant insertion and after osseointegrationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tomas Linkevicius
Lead sponsor
Lithuanian University of Health Sciences
Sponsor institution
Lithuanian University of Health Sciences
Collaborator
Source ClinicalTrials.gov
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