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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apical osteotomy | Experimental | Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction |
|
| Mesiodistal stability | Experimental | Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy. |
|
| Center molar | Experimental | Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket. |
|
| Palatinal molar | Experimental | Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental implant placement | Procedure | After tooth extraction, dental implant is placed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant success | Implant will be considered integrated if implant will meet criteria follwing criteria: •. The implant is in its original position.
| 16 weeks after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after delivery of final crown on an implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomas Linkevicius, PhD | Contact | +37068772840 | tomas.linkevicius@lsmu.lt | |
| Rokas Kuprys | Contact | info@picklinika.lt |
| Name | Affiliation | Role |
|---|---|---|
| Tomas Linkevicius | Lithuanian University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB "Panevėžio burnos chirurgijos centras" | Panevezys | Lithuania |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2026 | May 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| Dental implant | Device | 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. |
|
| 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 | At "Day 1" of implant placement |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |