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Influence of Alveolar Bone Drilling and Anatomical Position on Integration

1 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

124

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Panevezys, Lituanie
        • UAB "Panevėžio burnos chirurgijos centras"
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Implant success
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Marginal bone stability after one year post-treatment
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 mai 2028

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

9 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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