GBR With Ptfe With Bovine Bone With and Without Autogenous

Atrophied Anterior Maxillary Ridges Clinical Trial

Official title:

Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03628157
• Other study ID #: Bone augmentation
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2018
• Est. completion date: August 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: sherif hegazy, bachelor
• Phone: 00201008183867
• Email: shekosoa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

• 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.

• 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• • Patients with atrophied anterior maxillary ridge area.

• Age: 18 years and older.

• Both sexes.

• No intraoral soft and hard tissue pathology.

• No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

• • Heavy smokers more than 20 cigarettes per day.(32)

• Patients with systemic disease that may affect normal healing.

• Psychiatric problems.

• Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.

• Pregnant or nursing women.

• Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.

• Patient with previous history of radiotherapy.

Related Conditions & MeSH terms

• Atrophied Anterior Maxillary Ridges

Intervention

Other:
• Geistlich Bio-Oss® bovine bone alone
Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of bone gain (height and width in mm)	will be measured using linear measurements from CBCT	6 months
Secondary	a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)	a bone sample will be collected and analyzed under histo-morphometric analysis.	6 months