Clinical trial NCT01361321: Bone Quality and Quantity Following Guided Bone Regeneration
Official title: Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Ridge Augmentation
Keywords: follow up
Guided bone regeneration
Micro computerized tomography
histological examination
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healty over 18 years of age Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been insertd yet

Brief summary: Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.

Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.

The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women over 18 years of age, eligible for signing
2. Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
3. Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

1. Pregnant or nursing women. children or non judgemental patients
2. Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
3. Patients with a pathology present near the site of dental implantation

Primary outcomes:
measure: Volume of the new bone formed after a GBR procedure
timeFrame: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
Secondary outcomes:
measure: Bone quality
timeFrame: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
Other outcomes:
Locations:
city: Jerusalem,
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Department of Periodontology
name: Lior Shapira, Professor
role: PRINCIPAL_INVESTIGATOR
References: