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

October 19, 2018 updated by: haytham mohamed ahmed ibrahim, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Height and width of bone gained
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone area percentage
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • augmentation tunneling tech

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

within 2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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