Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
Clinical, Radiographic, and Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling in Mandibular Molar Extraction Sockets: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement.
The main questions it aims to answer are:
Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period?
Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes.
Participants will:
Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement.
Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling.
Receive the same implant system and standardized surgical and prosthetic protocols.
Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Immediate implant placement into fresh extraction sockets has become a well-established treatment approach because it reduces treatment time, decreases the number of surgical procedures, and helps preserve hard and soft tissue architecture. Nevertheless, obtaining adequate primary implant stability in fresh mandibular molar extraction sockets remains a major clinical challenge because of socket morphology, limited interradicular bone, and variations in bone density.
Osseodensification is a non-subtractive osteotomy preparation technique that uses specially designed burs rotating in a densifying mode to preserve and compact bone around the implant osteotomy. Unlike conventional drilling, which removes bone during osteotomy preparation, osseodensification compacts autogenous bone along the osteotomy walls, potentially increasing bone density, bone-to-implant contact, and primary implant stability while promoting favorable healing.
Although promising results have been reported for osseodensification, clinical evidence directly comparing this technique with conventional drilling during immediate implant placement in mandibular molar extraction sockets remains limited. This randomized clinical trial was designed to evaluate whether osseodensification provides superior clinical, radiographic, and implant stability outcomes compared with conventional drilling.
Eligible participants requiring extraction of a mandibular molar followed by immediate implant placement were randomly allocated to one of two treatment groups:
Osseodensification group: implant osteotomy prepared using the osseodensification drilling protocol.
Conventional drilling group: implant osteotomy prepared using the manufacturer's conventional drilling sequence.
All participants underwent atraumatic tooth extraction, immediate implant placement using the same implant system, grafting of the peri-implant gap when indicated according to the study protocol, customized healing abutment placement, and standardized prosthetic rehabilitation after the healing period. Postoperative care and follow-up schedules were standardized for both groups.
Clinical evaluations included assessment of the modified plaque index, modified bleeding index, and peri-implant probing depth. Implant stability was assessed using resonance frequency analysis and expressed as the Implant Stability Quotient (ISQ). Radiographic assessments included measurements of marginal bone loss using standardized periapical radiographs and peri-implant bone density using cone-beam computed tomography (CBCT). Participants were followed according to the study schedule to evaluate implant stability, peri-implant tissue health, and radiographic bone changes during healing and after functional restoration.
The primary objective of the trial was to compare primary and secondary implant stability between osseodensification and conventional drilling. Secondary objectives included comparison of peri-implant clinical parameters, marginal bone loss, and peri-implant bone density between the two treatment groups.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Riyadh, Arabie Saoudite, 11512
- Dar AlUloom University, College of Dentistry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.
Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.
Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.
Good oral hygiene and willingness to comply with the study protocol and follow-up visits.
Ability to understand the study procedures and provide written informed consent.
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Exclusion Criteria:
Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.
Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.
History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.
Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: osseodensification drilling group
Immediate implant placement using osseodensification drilling for implant osteotomy preparation.
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Implant osteotomy preparation was performed using the osseodensification drilling protocol with densifying burs rotating in densifying mode before immediate implant placement in mandibular molar extraction sockets.
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Comparateur actif: conventional drilling protocol
Immediate implant placement using the conventional drilling protocol for implant osteotomy preparation.
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Implant osteotomy preparation was performed using the conventional sequential drilling protocol before immediate implant placement in mandibular molar extraction
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Primary Implant Stability
Délai: Day 0, and 3 months
|
Implant stability, measured by the Implant Stability Quotient (ISQ) using resonance frequency analysis (RFA), assessed immediately after implant placement (primary stability) and during the follow-up period (at 3 months) to evaluate secondary stability. Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell® device. Stability will be expressed as the Implant Stability Quotient (ISQ), a unitless index ranging from 1 to 100, where higher ISQ values indicate greater implant stability. Measurements will be obtained by attaching a SmartPeg to the implant and recording ISQ values in two perpendicular directions (buccolingual and mesiodistal). The mean of the two measurements will be used for statistical analysis. Implant stability will be evaluated immediately after implant placement (baseline/primary stability), and at 3 months and 6 months postoperatively (secondary stability). The primary outcome will be the difference in mean ISQ values between the |
Day 0, and 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary Implant Stability
Délai: 3 months after implant placement
|
Secondary implant stability assessed using resonance frequency analysis (RFA) and expressed as the Implant Stability Quotient (ISQ).
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3 months after implant placement
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Marginal Bone Loss (MBL)
Délai: Baseline, 3 months, and 6 months after implant placement
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Marginal bone loss measured on standardized digital periapical radiographs as the distance from the implant reference point to the first bone-to-implant contact on the mesial and distal aspects.
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Baseline, 3 months, and 6 months after implant placement
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Peri-implant Bone Density
Délai: Baseline, 3 months, and 6 months after implant placement
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Bone density surrounding the implant measured using cone-beam computed tomography (CBCT) and expressed in Hounsfield Units (HU).
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Baseline, 3 months, and 6 months after implant placement
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Peri-implant Probing Depth (PPD)
Délai: 3 months and 6 months after implant placement
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Peri-implant probing depth measured in millimeters at four sites around each implant using a periodontal probe.
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3 months and 6 months after implant placement
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Modified Plaque Index (mPI)
Délai: Baseline, 3 months, and 6 months after implant placement
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Plaque accumulation around implants assessed using the Modified Plaque Index.
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Baseline, 3 months, and 6 months after implant placement
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Modified Bleeding Index (mBI)
Délai: Baseline, 3 months, and 6 months after implant placement
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Peri-implant soft tissue inflammation assessed using the Modified Bleeding Index.
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Baseline, 3 months, and 6 months after implant placement
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- # 37-03-2025
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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