Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2019-11-12

Brief Summary

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This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.

Detailed Description

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Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Conditions

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Bone Resorption Disorder

Keywords

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GBR, autogenous bone, xenograft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be randomly divided into 2 equal groups

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Each patient will be given a code by the researcher and the observers will be blind to which group this case belong.

Study Groups

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GBR by xenograft

* Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
* Local anesthesia will be given to the patient.
* Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
* Flap will be done.
* In the study group: bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
* • The site will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures.

Group Type PLACEBO_COMPARATOR

GBR by xenograft and autogenous bone

Intervention Type PROCEDURE

Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).

GBR by xenograft ,autogenous bone

Intervention In the control group:first crestal incision then two vertical incisions by blade 15c,full thickness flap reflection, bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area(atrophic maxilla) then covered by a native collagen membrane which will be stabilized by tacks.Then The flap will then be closed using interrupted 4/0 resorbable sutures.

Group Type ACTIVE_COMPARATOR

GBR by xenograft and autogenous bone

Intervention Type PROCEDURE

Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).

Interventions

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GBR by xenograft and autogenous bone

Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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hossam samir mohamed ahmed elbaha

Principal Investigator(doctor)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hossam Elbaha

Role: STUDY_CHAIR

Cairo University

Central Contacts

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Hossam Elbaha, Master

Role: CONTACT

Phone: +201277750002

Email: [email protected]

hossam Elbaha

Role: CONTACT

References

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Meloni SM, Jovanovic SA, Urban I, Canullo L, Pisano M, Tallarico M. Horizontal Ridge Augmentation using GBR with a Native Collagen Membrane and 1:1 Ratio of Particulated Xenograft and Autologous Bone: A 1-Year Prospective Clinical Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):38-45. doi: 10.1111/cid.12429. Epub 2016 Jun 9.

Reference Type RESULT

PMID: 27283920 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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