Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: 陈 莉丽, Master
- Numéro de téléphone: +86 13606507966
- E-mail: chenlili_1030@163.com
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- Recrutement
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Contact:
- 陈 莉丽, Master
- Numéro de téléphone: +86 13606507966
- E-mail: chenlili_1030@163.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18-80 years old;
- single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm;
- 4 weeks after extraction or missing teeth within 3-5 weeks;
- adjacent teeth exist and loosening is less than Ⅰ degree;
- periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;
- thick gingival biological type.
- CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient);
- the patients and their families have informed consent and signed the informed consent form.
Exclusion Criteria:
- pregnant and lactating women;
- smoking (> 10 cigarettes per day) and alcoholism;
- taking anticoagulants within 3 months before operation;
- suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;
- patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;
- patients who have been treated with bisphosphate / steroids for a long time;
- have received alveolar ridge bone augmentation surgery;
- previous history of radiotherapy in the head and neck;
- acute inflammation in edentulous sites;
- inability to maintain good oral hygiene or follow-up visits as required.
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 |
|---|---|
|
Expérimental: Control group
Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
Autres noms:
|
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Expérimental: Treatment group 1
Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
Autres noms:
|
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Expérimental: Treatment group 2
Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Buccal bone augmentation, BBA(bone height changes between T0 and T2)
Délai: T0(before surgery), T2(6 months after GBR)
|
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.
The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software.
The unit of measurement is millimeter.
|
T0(before surgery), T2(6 months after GBR)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Lingual bone augmentation, LBA(bone height changes between T0 and T2)
Délai: T0(before surgery), T2(6 months after GBR)
|
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. |
T0(before surgery), T2(6 months after GBR)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bone density, BD
Délai: T2(6 months after GBR)
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in the area of bone regeneration, ranging 2mm × 2mm
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T2(6 months after GBR)
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
- 2021-0050
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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