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Mandibular Ridge Splitting Versus Khoury Shell Technique

Primary Purpose

Horizontal Augmentation of Atrophic Posterior Mandible

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ridge splitting in group and khoury shell technique in the other group

About this trial

This is an interventional treatment trial for Horizontal Augmentation of Atrophic Posterior Mandible

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ridge splitting

khoury shell technique

Arm Description

Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws

bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws

Outcomes

Primary Outcome Measures

Amount of horizontal bone gain (bone width)

measurement using CBCT

Secondary Outcome Measures

Soft tissue healing

Dehiscence or no dehiscence

Full Information

NCT ID

NCT03781518

First Posted

November 1, 2018

Last Updated

December 18, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03781518

Brief Title

Mandibular Ridge Splitting Versus Khoury Shell Technique

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

July 1, 2018 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Horizontal Augmentation of Atrophic Posterior Mandible

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ridge splitting

Arm Type

Experimental

Arm Description

Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws

Arm Title

khoury shell technique

Arm Type

Active Comparator

Arm Description

bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws

Intervention Type

Procedure

Intervention Name(s)

ridge splitting in group and khoury shell technique in the other group

Intervention Description

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

Primary Outcome Measure Information:

Title

Amount of horizontal bone gain (bone width)

Description

measurement using CBCT

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Soft tissue healing

Description

Dehiscence or no dehiscence

Time Frame

1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

12611

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Mandibular Ridge Splitting Versus Khoury Shell Technique

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