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Influence of Alveolar Bone Drilling and Anatomical Position on Integration

1 de junio de 2026 actualizado por: Tomas Linkevicius, Lithuanian University of Health Sciences

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:

  1. Dental implants will be placed in the extraction socket with an apical osteotomy.
  2. Dental implants will be placed in the extraction socket without performing an osteotomy.
  3. Dental implants will be placed in the centre of the extracted maxillary molar socket.
  4. Dental implants will be placed into the palatal root socket of the extracted maxillary molar.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

124

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Panevezys, Lituania
        • UAB "Panevėžio burnos chirurgijos centras"
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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;

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Implant success
Periodo de tiempo: 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.
16 weeks after implant placement

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Marginal bone stability after one year post-treatment
Periodo de tiempo: 1 year after delivery of final crown on an implant
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
Implant insertion primary stability
Periodo de tiempo: At "Day 1" of implant placement
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Tomas Linkevicius, Lithuanian University of Health Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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