Mandibular Ridge Splitting Versus Khoury Shell Technique

Mandibular Ridge Splitting With Complete Separation of the Buccal Cortical Plate Versus Khoury Shell Technique for Horizontal Augmentation of Atrophic Posterior Mandible

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

Study Overview

• Status: Completed
• Conditions: Horizontal Augmentation of Atrophic Posterior Mandible
• Intervention / Treatment: Procedure: ridge splitting in group and khoury shell technique in the other group

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12611
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of horizontal bone gain (bone width)	measurement using CBCT	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue healing	Dehiscence or no dehiscence	1 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 290316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No