- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07589140
Influence of Alveolar Bone Drilling and Anatomical Position on Integration
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?
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tomas Linkevicius, PhD
- Telefonní číslo: +37068772840
- E-mail: tomas.linkevicius@lsmu.lt
Studijní záloha kontaktů
- Jméno: Rokas Kuprys
- E-mail: info@picklinika.lt
Studijní místa
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-
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Panevezys, Litva
- UAB "Panevėžio burnos chirurgijos centras"
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Kontakt:
- Rokas Kuprys
- Telefonní číslo: +37060727272
- E-mail: info@picklinika.lt
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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;
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Apical osteotomy
Megagen dental implants will be placed in the extraction socket with an apical osteotomy after atraumatic tooth extraction
|
After tooth extraction, dental implant is placed
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.
|
|
Experimentální: Mesiodistal stability
Megagen BlueDiamond implants will be placed in the extraction socket without performing an osteotomy.
|
After tooth extraction, dental implant is placed
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.
|
|
Experimentální: Center molar
Megagen BlueDiamond implants will be placed in the centre of the extracted maxillary molar socket.
|
After tooth extraction, dental implant is placed
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.
|
|
Experimentální: Palatinal molar
Megagen BlueDiamond implants will be placed into the palatal root socket of the extracted maxillary molar.
|
After tooth extraction, dental implant is placed
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Implant success
Časové okno: 16 weeks after implant placement
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Implant will be considered integrated if implant will meet criteria follwing criteria: •. The implant is in its original position.
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16 weeks after implant placement
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Marginal bone stability after one year post-treatment
Časové okno: 1 year after delivery of final crown on an implant
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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.
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1 year after delivery of final crown on an implant
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Implant insertion primary stability
Časové okno: At "Day 1" of implant placement
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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
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At "Day 1" of implant placement
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Tomas Linkevicius, Lithuanian University of Health Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Nr. 2026/4-1756-1203
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Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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