Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04049435
Other study ID # OMFS 3-3-14
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2019
Est. completion date October 1, 2021

Study information

Verified date August 2019
Source Cairo University
Contact Abdelwakeel Hamam
Phone 01119293865
Email dwakeel@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date October 1, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Horizontal deficient anterior maxilla < 3mm.

2. All ages >18 years

Exclusion Criteria:

- 1. Patients systemic disease or immunocomprmized status that may affect normal healing of bone, and predictable outcome.

2. Patients with history of previous grafting procedure 3. Patients with physical and psychological intolerance

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla
Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla

Locations

Country Name City State
Egypt Abdelwakeel Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70. Review. Erratum in: Int J Oral Maxillofac Implants. 2008 Jan-Feb;2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Horizontal bone gain Distanc buccolingually after 6 months
Secondary Gained bone quality measured by histomorphomerty examination of core biopsy Histomorphometry of core biopsy after 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05597956 - Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities N/A
Recruiting NCT05638373 - Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching N/A
Not yet recruiting NCT04355208 - Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle N/A
Completed NCT04685889 - Resin Infiltration Treatment for MIH N/A
Not yet recruiting NCT03717337 - Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth N/A
Not yet recruiting NCT03314545 - Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study" N/A
Completed NCT04060784 - Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield N/A
Completed NCT05973292 - Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations Phase 2