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The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible

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.
 
ClinicalTrials.gov Identifier: NCT03748615
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
walla farhat mohamed, Cairo University

Brief Summary:
The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations

Condition or disease Intervention/treatment Phase
Edentulous Patients Atrophic Posterior Mandible With Insufficient Width Device: Computer Guided ridge splitting in posterior mandible Not Applicable

Detailed Description:

Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.

Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.

In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.

As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : November 20, 2019

Arm Intervention/treatment
Experimental: Computer Guided ridge splitting in posterior mandible
fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery
Device: Computer Guided ridge splitting in posterior mandible

The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.

The selected patients will be informed of the nature of the research work and informed consent will be signed.

Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.

Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.

The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).

A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.

no flap elevation .





Primary Outcome Measures :
  1. Time of the procedure ,pain and edema [ Time Frame: 4 month ]
    the time of the procedure will be measured numerical using visual analogue scan



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748615


Contacts
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Contact: wallaa farahat mohamed, bds 01069543488 loulu_90_ooo@hotmail.com
Contact: mohammed khashaba, phd 01227754765 mohammedkhashaba@hotmail.com

Sponsors and Collaborators
Cairo University
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Responsible Party: walla farhat mohamed, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03748615    
Other Study ID Numbers: CairoUimplant master course
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases