Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

Bone Resorption Disorder Clinical Trial

Official title:

Ridge Augmentation in Atrophic Anterior Maxillary Ridges With Native Collagen 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: NCT03731416
• Other study ID #: Guided bone regeneration
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 12, 2019

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: Hossam Elbaha, Master
• Phone: +201277750002
• Email: hossam_elbaha[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 12, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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

• Bone Resorption
• Bone Resorption Disorder

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height and width of bone gained	Height and width of bone gained in mm by CBCT	6 months
Secondary	Bone area percentage	Bone area percentage % by Histo-morphometric analysis	6 months