Beta-Tricalcium Phosphate Grafting of Peri-implant Jumping Gaps Greater Than 2 mm in Immediate Implants
Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site.
Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed.
Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation.
Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ismailia, Egypte
- Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 20 to 50 years
- Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
- Peri-implant jumping gap greater than 2 mm at the implant site
- Adequate inter-arch space
- Good patient compliance
Exclusion Criteria:
• Systemic disease affecting healing
- Smoking of more than 10 cigarettes per day
- Parafunctional habits
- Poor oral hygiene
- Active periodontal disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: control; no grafting
Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with no grafting of the peri-implant gap.
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Expérimental: Test: beta-tricalcium phosphate grafting
Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with the gap filled with injectable β-tricalcium phosphate (β-TCP) after implant placement.
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A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Implant stability (implant stability quotient, ISQ)
Délai: Baseline (immediately postoperative), 3 months, and 6 months
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Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable).
The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.
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Baseline (immediately postoperative), 3 months, and 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Peri-implant bone density on periapical radiographs (Digora grayscale)
Délai: Baseline, 3 months, and 6 months
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Bone density on standardized digital periapical radiographs (paralleling technique, fixed exposure), analyzed with Digora software as grayscale values (0-255) at the mesial, distal, and apical regions.
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Baseline, 3 months, and 6 months
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Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)
Délai: 6 month
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Radiodensity on a single 6-month CBCT along the buccal aspect of each implant at apical, middle, and crestal levels, expressed as gray-value-derived HU-equivalent values; read independently by two blinded radiologists.
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6 month
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Implant survival
Délai: 6 months
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Proportion of implants surviving to the 6-month follow-up, with assessment of infection, implant mobility, and wound dehiscence at each visit.
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6 months
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 682/2023
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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