Horizontal Bone Gain Using Titanium Sheet (Case Series Study ).

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 ).

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)

Study Overview

• Status: Unknown
• Conditions: Anterior Teeth
• Intervention / Treatment: Device: Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla

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)

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Abdelwakeel Hamam; Phone Number: 01119293865; Email: dwakeel@yahoo.com
• Study Contact Backup: Name: Marwa Ali; Phone Number: 01008196639; Email: hamzawakeel2@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 002
    • Abdelwakeel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Case series

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
horizontal deficiency anterior maxilla; Using the titanium sheet in augmentation of horizontally deficient anterior maxilla will be efficient, time saving, accurate reconstruction	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal bone gain	Distanc buccolingually	after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gained bone quality measured by histomorphomerty examination of core biopsy	Histomorphometry of core biopsy	after 6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Abdelwakeel Mohammed, Investigator

Publications and helpful links

General Publications

• 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. Erratum In: Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):56.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 25, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OMFS 3-3-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.
• IPD Sharing Time Frame: 2years
• IPD Sharing Access Criteria: This study will carried out on patients attending clinic of Master program for Oral Implantology - Faculty of Dentistry Cairo University.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No