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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: 陈 莉丽, Master
- Telefoonnummer: +86 13606507966
- E-mail: chenlili_1030@163.com
Studie Locaties
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Werving
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Contact:
- 陈 莉丽, Master
- Telefoonnummer: +86 13606507966
- E-mail: chenlili_1030@163.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Buccal bone augmentation, BBA(bone height changes between T0 and T2)
Tijdsspanne: T0(before surgery), T2(6 months after GBR)
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lingual bone augmentation, LBA(bone height changes between T0 and T2)
Tijdsspanne: T0(before surgery), T2(6 months after GBR)
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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)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Bone density, BD
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021-0050
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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