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Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement

NCT ID: NCT01603693

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-21

Brief Summary

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Amongst the consequences of missing teeth are change of appearance and difficulties in mastication and speech. Dental implants in the maxilla or mandible provide a common treatment modality by offering anchorage to fixed or removable fixtures. In many cases, the lack of teeth is accompanied by lack of appropriate bone volume in the desired area for dental implant placement. Possible causes for this lack of sufficient bone volume are varied and include earlier bone atrophy, traumatic tooth extraction and bone resorption due to periodontal disease. In such cases, dental implant placement is preceded by alveolar bone augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in which a bulk of bone substitute is placed in the area which needs more volume before placing a dental implant. The bone substitute is covered with an inert membrane and may provide a scaffold and encourage cells from the patient to reach the area and build new bone volume. A common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM) which resembles human bone and helps encourage new bone formation. On the contrary its structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate is another common bone substitute with easy handling properties and good structural stability during early healing. Its replacement by natural bone contributes to the augmentation process. Although DBBM efficacy in GBR process has been investigated, using DBBM in combination with bi-phasic calcium-sulphate as a binding material during GBR was not examined. This prospective study will examine augmented bone quality and quantity following a GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in a combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will precede dental implant placement as custom. The quality and quantity of the new formed bone will be assessed by a C.T (computerized tomography) which is done routinely before dental implant placement and by further analyses of bone residues which will follow drilling the dental implant placement site while preparing it (as common).

Detailed Description

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Conditions

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Resorbed Alveolar Ridge Prior to Dental Implant Insertion

Keywords

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Guided bone regeneration Bio Oss BondBone computerized tomography histological examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bio-Oss

In this arm,GBR will be performed with DBBM (Bio-Oss, Geistlich) in 25 patients.

Group Type EXPERIMENTAL

Bio-Oss (by Geistlich)

Intervention Type DEVICE

Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.

Bio-Oss and BondBone

In this arm, GBR will be performed using a combination of DBBM (Bio-Oss, Geistlich) and bi-phasic calcium sulphate (BondBone, Augma) in 25 patients.

Group Type EXPERIMENTAL

Bio-Oss (by Geistlich)

Intervention Type DEVICE

Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.

BondBone (by Augma)

Intervention Type DEVICE

Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.

Interventions

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Bio-Oss (by Geistlich)

Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.

Intervention Type DEVICE

BondBone (by Augma)

Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.

Intervention Type DEVICE

Other Intervention Names

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Deproteinized Bovine Bone Mineral bi-phasic Calcium-Sulphate

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women over 18 years of age, eligible for signing
* Edentulus Patients who require a GBR procedure previous to an insertion of a dental implant
* Patients who understand the meaning of the treatment (routine Guided Bone Regeneration and dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria

* Pregnant or nursing women.
* C567890-hildren or non judgemental patients
* Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
* Patients with a pathology present near the site of dental implantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Lang NP, Hammerle CH, Bragger U, Lehmann B, Nyman SR. Guided tissue regeneration in jawbone defects prior to implant placement. Clin Oral Implants Res. 1994 Jun;5(2):92-7. doi: 10.1034/j.1600-0501.1994.050205.x.

Reference Type BACKGROUND
PMID: 7918914 (View on PubMed)

Other Identifiers

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BioOss-BondBone-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id