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Clinical Trials/NCT04049435
NCT04049435
Unknown
Not Applicable

Assessment of Horizontal Bone Gain Using Patient Specific Titanium Sheet: a Novel Protocol for Treatment of Horizontal Deficiency in the Anterior Maxilla (Case Series Study ).

Cairo University1 site in 1 country10 target enrollmentSeptember 25, 2019
ConditionsAnterior Teeth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Teeth
Sponsor
Cairo University
Enrollment
10
Locations
1
Primary Endpoint
Horizontal bone gain
Last Updated
6 years ago

Overview

Brief Summary

The horizontal deficient anterior maxilla less than 3mm presents considerable challenges for surgical and prosthetic reconstruction. caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement(Aghaloo & Moy, 2007)

Detailed Description

The successful use of dental implants for replacing missing dentition requires adequate available bone in the treatment planning phase and inserting the implant in the correct 3D position to achieve good esthetic and function outcomes.(Rieder et al., 2016) The horizontal deficient anterior maxilla presents considerable challenges for surgical and prosthetic reconstruction. Inadequate alveolar ridge width caused by trauma , infection, congenitally missing teeth or resorption subsequent to dental extractions hampers dental implant placement (Aghaloo \& Moy, 2007) Avariety of bone augmentation technigue have been described to enhance the bone volume of the deficient implant recipient site such as autogenous bone graft ,synthetic bone graft ,distraction osteogenesis ,ridge splitting, guided bone regeneration(Rakhmatia, Ayukawa, Furuhashi, \& Koyano, 2013)(Gulinelli et al., 2017) Autograft remain the gold standard with the capacity to regenerate and forming new bone through its osteogenic ,osteoconductive and osteoinductive properties which can be obtained from chin area (Donos, Mardas, \& Chadha, 2008). Due to the limited availabity of autograft in case of sever resorped ridge ,xenogrft can be mixed to increase the amount of bone applied to the defective area(Monje et al., 2015) However considerable graft resorption following augmentation and the graft was not sufficiently stable during the healing period ,the titanium membrane or sheet used to overcome this problem(Andreasi Bassi et al., 2016) The titanium sheet is non resorbable membrane , impermeable ,rigid acts as space maintainance, clot protection , a barrier preventing bacterial contamination of the gaft , stopping the graft resorption , less morbid,less operative time , more accurate for contour reconstruction than the well known autogenous bone technique (Andreasi Bassi et al., 2016) Computer aided design/computer aided manufacturing technology (CAD/CAM) have been established in creation of three dimensional(3D) framework , Digitally virtually planned regenerated ridge was created from a cone-beam computerized tomography (CBCT) using specialized DICOM image ( Digital imaging and communication in medicine reconstructing 3D surgical model, and the design of the titanium sheet with the location of the bone screws was preserved. The new 3D surgical model with the simulated surgery was used to fabricate titanium sheet positioning with all required dimensions decreasing the overall operative time .(Al-Ardah et al., 2018) The quality of newly formed bone will be evaluated by histologically at the time of implant placement , core biopsies will be retrieved . the specimen will immediately fixed in 10% buffered formalin for 1 week, then decalcified and processed according to standardized protocol Ethylenediamine-tetracetic acid (EDTA)-formic acid combination differentiating the newly formed bone end from the native bone end for histologic analysis(Atef, Hakam, Elfaramawey, Abou-Elfetouh, \& Ekram, 2014) Following postoperative healing period of 6 months CBCT scan will take to evaluate the horizontal bone gain and planning of implant surgery(Mendoza-Azpur, Fuente, Chavez, Valdivia, \& Khouly, 2019)

Registry
clinicaltrials.gov
Start Date
September 25, 2019
End Date
October 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdelwakeel mohamed abdelrahman hamam

Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla (Case series study ).

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Horizontal deficient anterior maxilla \< 3mm.
  • All ages \>18 years

Exclusion Criteria

  • Patients systemic disease or immunocomprmized status that may affect normal healing of bone, and predictable outcome.
  • Patients with history of previous grafting procedure
  • Patients with physical and psychological intolerance

Outcomes

Primary Outcomes

Horizontal bone gain

Time Frame: after 6 months

Distanc buccolingually

Secondary Outcomes

  • Gained bone quality measured by histomorphomerty examination of core biopsy(after 6 months)

Study Sites (1)

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