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Ridge Augmentation in Posterior Mandible Using Tunneling Technique With Amix of Autogenous Bone and Xenograft With and Without Collagen Membrane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03712631
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 22, 2018
Information provided by (Responsible Party):
haytham mohamed ahmed ibrahim, Cairo University

Brief Summary:
aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane

Condition or disease Intervention/treatment Phase
Alveolar Ridge Augmentation Procedure: tunneling technique bone augmentation Not Applicable

Detailed Description:

Bone grafting before implant placement has become a routine procedure over the last 20 years. A 5-year survival rate of up to98.3% for implants placed in grafted bone has been reported.

Autologous bone grafts are considered the gold standard.However, the success rate of the grafting procedure may beinfluenced by various risk factors.

A particular challenge isposed by an extensive graft of the alveolar ridge, with relativelyhigh complication rates of up to 20% being reported, mostcommonly dehiscence. More serious complications such asdehiscence or mobilization of the graft were observed in one third of smokers compared to a complication rate of only 7.7%for non-smokers. Complications such as flap necroses, dehiscenceand resorption are frequently soft-tissue complications.

A tension-free wound closure is a key factor in the successof bone grafts. Periosteal incisions are a common techniquefor flap extension. However, too many relief incisions in the periosteum may also result in an excessively thin or stretched wound flap.

This type of soft-tissue management may result in perforation or flap necrosis above the bone graft.

In 1987 Härle reported on a tunneling access in connectionwith a technique for preprosthetic jaw ridge grafting in the mandibular side-tooth region with bone replacement materials.

In the clinical experience of the authors the use of a tunneling technique for preparation without a crestal incision can present an alternative with autologous bone grafts to conventional surgical procedures with a trapezoid flap design.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ridge Augmentation in Atrophic Posterior Mandible Using Tunneling Technique With Anorganic Bovine Bone-Derived Mineral Mixed With Particulated Autogenous Bone Chips With and Without Collagen Membrane
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: bone without a collagen membrane
not covering bone with collagen membrane
Procedure: tunneling technique bone augmentation
horizontal ridge augmentation using mixture of xenograft,autogenous bone

Experimental: bone with collagen membrane
covering bone with collagen membrane
Procedure: tunneling technique bone augmentation
horizontal ridge augmentation using mixture of xenograft,autogenous bone

Primary Outcome Measures :
  1. Height and width of bone gained [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Bone area percentage [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion Criteria:

smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Publications of Results:
Other Publications:
9. Fonseca RJ, Powers MP, Dexter H. Oral and max¬illofacial surgery: Reconstructive and implant surgery. Philadelphia: WB Saunders Co. 2007; 7.

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Responsible Party: haytham mohamed ahmed ibrahim, dr, Cairo University Identifier: NCT03712631    
Other Study ID Numbers: augmentation tunneling tech
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: within 2 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by haytham mohamed ahmed ibrahim, Cairo University:
tunneling technique
collagen membrane
horizontal ridge augmentation
bone graft
ridge augmentation
posterior mandible