NCT07589140

Brief Summary

The goal of this clinical trial is to learn if alveolar bone drilling and anatomical position of an immediately placed dental implant has influence on the primary stability, osseointegration and function. The main questions it aims to answer are:

  • Is absence of alveolar drilling before implant placement gives the same result as traditional osteotomy with apical drilling?
  • Is palatinal root position of implant as succesful as central position? Researchers will compare crestal bone levels and primary stability of the implant after insertion is the groups. Subjects will be assigned to groups, acoording to clinical situation. Study groups:
  • Dental implants will be placed in the extraction socket with an apical osteotomy.
  • Dental implants will be placed in the extraction socket without performing an osteotomy.
  • Dental implants will be placed in the centre of the extracted maxillary molar socket.
  • Dental implants will be placed into the palatal root socket of the extracted maxillary molar.

Trial Health

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Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 Progress7%
Apr 2026May 2028

Study Start

First participant enrolled

April 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

April 29, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

dental implant

Outcome Measures

Primary Outcomes (1)

  • Implant success

    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.

    16 weeks after implant placement

Secondary Outcomes (2)

  • Marginal bone stability after one year post-treatment

    1 year after delivery of final crown on an implant

  • Implant insertion primary stability

    At "Day 1" of implant placement

Study Arms (4)

Apical osteotomy

EXPERIMENTAL

Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction

Procedure: dental implant placementDevice: Dental implant

Mesiodistal stability

EXPERIMENTAL

Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy.

Procedure: dental implant placementDevice: Dental implant

Center molar

EXPERIMENTAL

Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket.

Procedure: dental implant placementDevice: Dental implant

Palatinal molar

EXPERIMENTAL

Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar.

Procedure: dental implant placementDevice: Dental implant

Interventions

After tooth extraction, dental implant is placed

Apical osteotomyCenter molarMesiodistal stabilityPalatinal molar

Small sterile titanium screw-type with rough surface placed it into the jawbone - just underneath the gum. The titanium implant will fuse over the bone (also known as osseointegration), forming an anchor for a replacement tooth.

Apical osteotomyCenter molarMesiodistal stabilityPalatinal molar

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 Sites (1)

UAB "Panevėžio burnos chirurgijos centras"

Panevezys, Lithuania

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Tomas Linkevicius

    Lithuanian University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Linkevicius, PhD

CONTACT

Rokas Kuprys

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data cannot be shared as this is required by Vilnius Regional Biomedical Research Ethics Committee, which issued the permission to conduct this study

Locations