Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496688
Other study ID # 3447/18.12.2014
Secondary ID
Status Completed
Phase N/A
First received March 29, 2018
Last updated April 5, 2018
Start date January 12, 2015
Est. completion date September 11, 2017

Study information

Verified date April 2018
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 11, 2017
Est. primary completion date January 4, 2016
Accepts healthy volunteers No
Gender All
Age group 33 Years to 70 Years
Eligibility Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class 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.

Exclusion Criteria:

Study Design


Intervention

Procedure:
Sinus floor augmentation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 month-healing after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT02880891 - Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants N/A
Completed NCT00748241 - Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading N/A
Active, not recruiting NCT04066309 - Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow N/A
Active, not recruiting NCT04545840 - Prospective Neodent® Zirconia System Study
Active, not recruiting NCT06034067 - Osseodensification Versus Conventional Drilling for Implant Site Preparation N/A
Active, not recruiting NCT04546269 - Fully Guided Versus Conventionally Guided Implant Placement by Dental Students N/A
Recruiting NCT02676661 - Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease N/A
Recruiting NCT02662361 - Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease:a Retrospective Study N/A
Completed NCT01030523 - Short Implants - An Alternative to Bone Grafting? N/A
Completed NCT00906425 - Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla N/A
Completed NCT03252106 - Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement N/A
Completed NCT02975674 - Evaluation of MT-12 Implant Survival and Marginal Bone Loss N/A
Completed NCT01822223 - A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing N/A
Completed NCT00545818 - Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw N/A
Completed NCT00900822 - Straumann Bone Ceramic Versus BioOss in Sinus Elevation N/A
Completed NCT04017026 - Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
Active, not recruiting NCT05315414 - Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations N/A
Recruiting NCT02814149 - Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement N/A
Active, not recruiting NCT03319758 - Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall N/A
Completed NCT01807416 - Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study Phase 4