Dental ImplantNCT07589140
Influence of Alveolar Bone Drilling and Anatomical Position on Integration
A study testing dental implant placement and Dental implant in people with Dental Implant and Bone Grafting, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Bone Grafting, Immediate Dental Implant Placement
- What is being tested?
- dental implant placement and Dental implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteLithuania
- Study dates
- Jul 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rokas Kuprys contact
Lithuania1 site
UAB "Panevėžio burnos chirurgijos centras"
Panevezys
Rokas Kuprys, +37060727272, info@picklinika.lt
About this study
Official title: Influence of Alveolar Bone Drilling and Anatomical Position on the Primary Stability, Osseointegration and Functioning of Immediately Placed Dental Implants
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. It aims to answer these questions:
- Does absence of alveolar drilling before implant placement give the same result as traditional osteotomy with apical drilling?
- Is palatinal root position of implant as succesful as central position?
Read more
Researchers will compare crestal bone levels and primary stability of the implant after insertion in 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.
Read the detailed description
Tooth extraction and subsequent implantation will be performed under local anesthesia. After tooth extraction, an osteotomy is performed in the tooth socket to create a bed for the implant. The patients will be divided into groups based on the bone condition after tooth extraction. Participants in this study were scheduled for tooth extraction followed by immediate implant placement. One hour prior to the procedure, patients were administered 1 g of amoxicillin orally, which was continued at a dosage of twice daily for one week after the procedure. Teeth were extracted under local anesthesia using 4% articain with epi-nephrine 1:100000 (Ubistesin forte, 3M ESPE, USA), with an emphasis on minimizing trauma and avoiding flap elevation, employing root sectioning if necessary. Care was taken to preserve the marginal gingiva and papillae. Following extraction, the socket was cleaned and assessed. Osteotomies were created using the original drills in a sequence specified by the implant manufacturer. The implant was placed centrally in the me-sio-distal aspect and more towards the lingual/palatal side of the socket. The insertion torque was recorded with manual torque wrench. Anatomical or individual healing abutments were used after implant placement. Individual healing abutments were crafted chairside using original titanium temporary abutments and flowable composite, creating critical and subcritical contours. The composite was polished meticulously. All healing abutments were secured on the implants with 15 Ncm torque. Postoperative instructions were provided both verbally and, in a booklet, advising patients to rinse their mouths twice daily for 2 weeks with a commercially available mouth rinse containing 0.12% chlorhexidine di-gluconate.
After 4 months, the osseointegration of implants was evaluated for presence or absence of following symptoms: pain, recurrent peri-implant infections, mobility on manual palpation and continuous peri-implant radiolucency. If those symptoms were absent, implant was deemed successfully integrated and implant schedulled for restoration. During prosthetic visit, open tray transfer was connected to the implant and open tray silicone impressions for final restorations were taken. Healing abutment put back to the implant. In the lab a screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the polishing protocol were fabricated. At the delivery date, zirconia crown retained to the implant with fingers and torqued to 35N/cm using implant wrentch. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite . Individual oral hygiene instructions were provided both verbally and in booklet form. Scheduling of follow-up visits were carried out after 1 year of last dental visit.
- Being tested
- dental implant placement, Dental implant
- Keywords
- dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
After tooth extraction, dental implant is placed
Dental implantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Apical osteotomy | Experimental | Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction Receives: Procedure: dental implant placement; Device: Dental implant |
| Mesiodistal stability | Experimental | Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy. Receives: Procedure: dental implant placement; Device: Dental implant |
| Center molar | Experimental | Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket. Receives: Procedure: dental implant placement; Device: Dental implant |
| Palatinal molar | Experimental | Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar. Receives: Procedure: dental implant placement; Device: Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success
Implant will be considered integrated if implant will meet criteria follwing criteria:
•. 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.
Measured: 16 weeks after implant placement
Secondary outcomes (2)
Marginal bone stability after one year post-treatment
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.
Measured: 1 year after delivery of final crown on an implant
Implant insertion primary stability
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
Measured: At "Day 1" of implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Linkevicius, Lithuanian University of Health Sciences
- Investigators
- Tomas Linkevicius, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589140
- Sponsor's protocol ID
- Nr. 2026/4-1756-1203
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared as this is required by Vilnius Regional Biomedical Research Ethics Committee, which issued the permission to conduct this study
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Alveolar Bone Drilling and Anatomical Position on the Primary Stability, Osseointegration and Functioning of Immediately Placed Dental Implants
- ClinicalTrials.gov ID
- NCT07589140
- Acronym / sponsor ID
- Nr. 2026/4-1756-1203
- Keywords
- dental implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It aims to answer these questions:
- Does absence of alveolar drilling before implant placement give 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 in 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.
Detailed description
Tooth extraction and subsequent implantation will be performed under local anesthesia. After tooth extraction, an osteotomy is performed in the tooth socket to create a bed for the implant. The patients will be divided into groups based on the bone condition after tooth extraction. Participants in this study were scheduled for tooth extraction followed by immediate implant placement. One hour prior to the procedure, patients were administered 1 g of amoxicillin orally, which was continued at a dosage of twice daily for one week after the procedure. Teeth were extracted under local anesthesia using 4% articain with epi-nephrine 1:100000 (Ubistesin forte, 3M ESPE, USA), with an emphasis on minimizing trauma and avoiding flap elevation, employing root sectioning if necessary. Care was taken to preserve the marginal gingiva and papillae. Following extraction, the socket was cleaned and assessed. Osteotomies were created using the original drills in a sequence specified by the implant manufacturer. The implant was placed centrally in the me-sio-distal aspect and more towards the lingual/palatal side of the socket. The insertion torque was recorded with manual torque wrench. Anatomical or individual healing abutments were used after implant placement. Individual healing abutments were crafted chairside using original titanium temporary abutments and flowable composite, creating critical and subcritical contours. The composite was polished meticulously. All healing abutments were secured on the implants with 15 Ncm torque. Postoperative instructions were provided both verbally and, in a booklet, advising patients to rinse their mouths twice daily for 2 weeks with a commercially available mouth rinse containing 0.12% chlorhexidine di-gluconate.
After 4 months, the osseointegration of implants was evaluated for presence or absence of following symptoms: pain, recurrent peri-implant infections, mobility on manual palpation and continuous peri-implant radiolucency. If those symptoms were absent, implant was deemed successfully integrated and implant schedulled for restoration. During prosthetic visit, open tray transfer was connected to the implant and open tray silicone impressions for final restorations were taken. Healing abutment put back to the implant. In the lab a screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the polishing protocol were fabricated. At the delivery date, zirconia crown retained to the implant with fingers and torqued to 35N/cm using implant wrentch. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite . Individual oral hygiene instructions were provided both verbally and in booklet form. Scheduling of follow-up visits were carried out after 1 year of last dental visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apical osteotomy | Experimental | Procedure: dental implant placement, Device: Dental implantMegagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction |
| Mesiodistal stability | Experimental | Procedure: dental implant placement, Device: Dental implantMegagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy. |
| Center molar | Experimental | Procedure: dental implant placement, Device: Dental implantMegagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket. |
| Palatinal molar | Experimental | Procedure: dental implant placement, Device: Dental implantMegagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant placementAfter tooth extraction, dental implant is placed | Procedure or surgery | Apical osteotomy, Center molar, Mesiodistal stability, Palatinal molar |
| Dental implantSmall 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. | Device | Apical osteotomy, Center molar, Mesiodistal stability, Palatinal molar |
Primary outcome
Implant success
Time frame: 16 weeks after implant placement
Implant will be considered integrated if implant will meet criteria follwing criteria: •. 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.
2 secondary outcomes
Marginal bone stability after one year post-treatment
Time frame: 1 year after delivery of final crown on an implant
Implant insertion primary stability
Time frame: At "Day 1" of implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Data cannot be shared as this is required by Vilnius Regional Biomedical Research Ethics Committee, which issued the permission to conduct this study
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Tooth Loss and Rehabillitation, Dental Implant Failure
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rokas Kuprys contact
Tomas Linkevicius principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant placement and Dental implant in people with Dental Implant and Bone Grafting, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomas Linkevicius, PhD (+37068772840, tomas.linkevicius@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success (time frame: 16 weeks after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.