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GBR With Ptfe With Bovine Bone With and Without Autogenous

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03628157
Enrollment
10
Registered
2018-08-14
Start date
2018-09-30
Completion date
2019-08-31
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophied Anterior Maxillary Ridges

Brief 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.

Interventions

OTHERGeistlich Bio-Oss® bovine bone alone

Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of bone gain (height and width in mm)6 monthswill be measured using linear measurements from CBCT

Secondary

MeasureTime frameDescription
a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)6 monthsa bone sample will be collected and analyzed under histo-morphometric analysis.

Countries

Egypt

Contacts

Primary Contactsherif hegazy, bachelor
shekosoa@gmail.com00201008183867

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026