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Immediate Dental Implant PlacementNCT07585539

Influence of the Primary Stability and Temporary Prosthetics

A study testing Implant placement, Healing abutment and Temporary crown in people with Immediate Dental Implant Placement and Immediate Dental Implant Loading, run by Tomas Linkevicius.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implant placement, Healing abutment and Temporary crown
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
7 May 2026to 5 Jan 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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tomas Linkevicius, PhD, DDS contact

+37068772840

tomas.linkevicius@lsmu.lt

Marius Svedas contact

svedasm@gmail.com

About this study

Official title: Influence of the Primary Stability and Temporary Prosthetics of a Placed Dental Implant on Implant Osseointegration and Further Function When Performing Immediate Implantation in the Posterior Tooth Regions.

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.

Read the detailed description

In Group 1 and Group 2 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 (3M Supreme Filtek Flow, 3M ESPE, USA), creating critical and subcritical contours. The composite was polished meticulously. All immediate implant sites were grafted with allogenic cortical/cancellous particulate (1000-1700 micron) bone and 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 ab-sence 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 silicone impressions for final restorations were taken. Screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the protocol described by Linkevicius et al. 2017 were delivered. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite (Figure 3D). 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.

In Group 3 Following the extraction of molars under local anaesthesia, socket was debrided using surgical curette until hard bone surface was felt. Following copious irrigation with saline, an ultrawide diameter implant(8.0mm X8.0mm; Megagen Anyridge) was placed in the depth of the socket with zero insertion torque (T1). Socket was then allowed to fill with fresh blood. The remaining part of the socket present coronal to implant platform (measuring 6mm approx.) was then sealed with xenograft particles in a similar manner to alveolar ridge preservation. This was carried out in order to prevent the resorption of buccolingual width while simultaneously utilizing the benefits of immediate implant placement. In order to separate the xenograft particles from the oral microenvironment, a non-resorbable d-PTFE membrane was placed with its edges inserted into buccal and lingual flaps. This was further secured using criss cross sutures(5-0 Polyglycolic acid) along the occlusal surface. Suture removal was done 10 days post operatively and the site was allowed to heal for 04 months. d-PTFE membrane was then removed which revealed completely epithelialized with xenograft particles integrated over the implant platform which was confirmed on the radiograph.

Stage II implant exposure surgery was performed after 04 months of implant placement. Implant was deemed successful if there was no implant mobility and apparently healthy mucosa around implant.

Being tested
Implant placement, Healing abutment, Temporary crown, Bone grafting of the implant, Non-resorbable membrane
Keywords
Dental implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant placementProcedure or surgery

    After tooth extraction, dental implant is placed

  • Healing abutmentProcedure or surgery

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

  • Temporary crownProcedure or surgery

    Prefabricated temporary crown is attcahed to the implant after implant placement

  • Bone grafting of the implantProcedure or surgery

    After implant placement, bone graft is applied to extraction socket

  • Non-resorbable membraneProcedure or surgery

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

Study groups in NCT07585539
Study groupRoleWhat they receive
5-10 N/cmExperimentalStability 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.
Receives: Procedure: Implant placement; Procedure: Bone grafting of the implant; Procedure: Non-resorbable membrane
15-35 N/cmExperimentalStability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed
Receives: Procedure: Implant placement; Procedure: Healing abutment; Procedure: Bone grafting of the implant
40 N/cm and moreExperimentalStability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed.
Receives: Procedure: Implant placement; Procedure: Temporary crown; Procedure: Bone grafting of the implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After 4 months post-insertion

Secondary outcomes (8)
  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

    Measured: After implant placement and after 4 months post-healing

  2. 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.

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

  3. 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

    Measured: After prosthesis delivery and after 1 year

  4. 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.

    Measured: After implant insertion and after osseointegration

  5. Plaque Index (PI)

    Plaque index is calucated visually by scoring from 0-3. 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. 3 = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth.

    Measured: After prosthesis delivery and after 1 year

  6. Gingival volume around the implants

    Gingival volume around the implants will measured in mm3 from intraoral scans of implant-supported restoration.

    Measured: After prosthesis delivery and after 1 year

  7. Probing Pocket Depth (PPD)

    PPD will measured in mm with periodontal probe. Periodontal probing depth (PPD) is measured from the gingival margin to the base/bottom (coronal portion of the junctional epithelium (JE) of the periodontal pocket to the nearest mm. 4 points around each implant prosthesis will be measured - mesiobucal, distobucal, mesiolingual/palatinal and distolingual/palatinal. The mean number of 4 measurements will be presented

    Measured: After prosthesis delivery and after 1 year

  8. Bleeding on Probing (BOP)

    Bleeding on probing is registered during pocket probing. Sites are characterized by the absence of BOP as well as the absence of GI bleeding (scores 0 and 1)

    Measured: After prosthesis delivery and after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start7 May 2026 (estimated)
  3. Primary completion16 Oct 2027 (estimated)
  4. Study completion5 Jan 2028 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585539
Sponsor's protocol ID
Nr. 2026/4-1735-1199
Status last verified
May 2026
First submitted
4 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Implant placement, Healing abutment and Temporary crown in people with Immediate Dental Implant Placement and Immediate Dental Implant Loading, run by Tomas Linkevicius.

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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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, DDS (+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 oseointegration (time frame: After 4 months post-insertion). 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 13 May 2026.

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