NCT07585539

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jan 2028

First Submitted

Initial submission to the registry

May 4, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2028

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 4, 2026

Last Update Submit

May 9, 2026

Conditions

Immediate Dental Implant LoadingMarginal Bone LevelsImmediate Dental Implant Placement

Keywords

Dental implant

Outcome Measures

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.

    After 4 months post-insertion

Secondary Outcomes (8)

  • Implant insertion depth

    After implant placement and after 4 months post-healing

  • Marginal bone loss

    After delivery of implant restoration and after 1 y follow-up

  • PES (pink esthetic score) index

    After prosthesis delivery and after 1 year

  • Implant stability quotient (ISQ) value

    After implant insertion and after osseointegration

  • Plaque Index (PI)

    After prosthesis delivery and after 1 year

  • +3 more secondary outcomes

Study Arms (3)

5-10 N/cm

EXPERIMENTAL

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.

Procedure: Implant placementProcedure: Bone grafting of the implantProcedure: Non-resorbable membrane

15-35 N/cm

EXPERIMENTAL

Stability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed

Procedure: Implant placementProcedure: Healing abutmentProcedure: Bone grafting of the implant

40 N/cm and more

EXPERIMENTAL

Stability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed.

Procedure: Implant placementProcedure: Temporary crownProcedure: Bone grafting of the implant

Interventions

Implant placementPROCEDURE

After tooth extraction, dental implant is placed

15-35 N/cm40 N/cm and more5-10 N/cm
Healing abutmentPROCEDURE

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

15-35 N/cm
Temporary crownPROCEDURE

Prefabricated temporary crown is attcahed to the implant after implant placement

40 N/cm and more
Bone grafting of the implantPROCEDURE

After implant placement, bone graft is applied to extraction socket

15-35 N/cm40 N/cm and more5-10 N/cm
Non-resorbable membranePROCEDURE

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

5-10 N/cm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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%);
  • intact alveolar bone walls post-extraction
  • signed informed consent form and permission to use the obtained data for research purposes.

You may not qualify if:

  • Smokers (≥ 10 cigarettes per day);
  • history of uncontrolled periodontitis;
  • uncontrolled diabetes/alcoholism;
  • use of drugs that may affect healing;
  • persons who, due to health status, cannot be considered capable of reasonably assessing their interests;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tomas Linkevicius, PhD, DDS

    Lithuanian University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Linkevicius, PhD, DDS

CONTACT

+37068772840tomas.linkevicius@lsmu.lt

Marius Svedas

CONTACT

svedasm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 13, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

October 16, 2027

Study Completion (Estimated)

January 5, 2028

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
July 2026-July 2027
Access Criteria
Qualified researchers at accredited institutions (academia, government, non-profit, industry with legitimate scientific intent) will be eligable for sharing. Access will be granted upon resonable request via secure controlled environment (virtual data enclave, Secure Research Environment) or encrypted transfer to approved secure servers. Datasets will be de-identified consistent with prevailing standards.