An interventional study of Sinus floor augmentation in Atrophy, Jaw, Edentulous, Partially and Sinus Floor Augmentation, sponsored by University of Roma La Sapienza. Completed. Open to participants aged 33 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.
Materials and Methods:
A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).
76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 67 interventional studies indexed under Jaw, Edentulous, Partially.
Browse Jaw, Edentulous, Partially studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Compared within Jaw, Edentulous, Partially, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Atrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: patients healthy, absence of systemic pathologies ( I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using mineralized sol-vent-dehydrated bone allograft material.
Procedure: Sinus floor augmentation
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using freeze-dried mineralized bone allograft material.
Procedure: Sinus floor augmentation
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using anorganic bovine bone material.
Procedure: Sinus floor augmentation
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using equine-derived bone material.
Procedure: Sinus floor augmentation
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using synthetic micromacroporous bi-phasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hy-droxyapatite material.
Procedure: Sinus floor augmentation
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using bioapatite-collagen material.
Procedure: Sinus floor augmentation
to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.
After 6 months clinical and radiographic examinations were undertaken and each patient was reappointed for biopsy at the time of implant placement in the same location. Under local anesthesia, a full thickness flap was raised, a biopsy was performed using a 3.5 mm tre-phine bur under sterile saline solution irrigation, guided by the radiographic/surgical template in the selected implant site. A total of six bone samples was retrieved from the occlusal aspect to the alveolar crest, one from each augmented site to compare histologically and histomorphometrically the different materials.
Time frame: 6 month-healing after surgery
No study locations are listed for this record.
Plan to share: Undecided
Ran from Jan 2015 to primary completion in Jan 2016, 11 months.
Of 34 interventional studies with no phase under Jaw, Edentulous, Partially, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 61. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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