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Mandibular Ridge Splitting Versus Khoury Shell Technique

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ClinicalTrials.gov Identifier: NCT03781518
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Omnia El- Atawy, Cairo University

Study Description
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Brief Summary:
Mandibular ridge splitting with complete separation of the buccal cortical plate versus Khoury shell technique for horizontal augmentation of atrophic posterior mandible

Condition or disease Intervention/treatment Phase
Horizontal Augmentation of Atrophic Posterior Mandible Procedure: ridge splitting in group and khoury shell technique in the other group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mandibular Ridge Splitting With Complete Separation of the Buccal Cortical Plate Versus Khoury Shell Technique for Horizontal Augmentation of Atrophic Posterior Mandible
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: ridge splitting
Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws
 Procedure: ridge splitting in group and khoury shell technique in the other group
Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus
Active Comparator: khoury shell technique
bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws
 Procedure: ridge splitting in group and khoury shell technique in the other group
Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus


Outcome Measures
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Primary Outcome Measures :
  1. Amount of horizontal bone gain (bone width) [ Time Frame: 4 months ]
    measurement using CBCT


Secondary Outcome Measures :
  1. Soft tissue healing [ Time Frame: 1 months ]
    Dehiscence or no dehiscence


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with atrophic mandible with residual bone width 3 to 4 mm.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • • Any pathology in the posterior mandible.

    • 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.
Contacts and Locations
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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): NCT03781518


Locations
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Egypt
Cairo University
Cairo, Egypt, 12611
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Omnia El- Atawy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03781518    
Other Study ID Numbers: 290316
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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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Atrophy
Pathological Conditions, Anatomical