Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge

Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge (Randomized Clinical Trial)

In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery????

Study Overview

• Status: Unknown
• Conditions: Ridge Deficency
• Intervention / Treatment: Procedure: Computer guided surgical cutting guide; Procedure: Conventional alveolar ridge splitting

Detailed Description

PICO P- Horizontal deficient alveolar ridge in Anterior Maxillary Region I- Computer guided surgical cutting guide C- Conventional alveolar ridge splitting O- Clinical outcome and radiographic outcomes Primary outcome: Accuracy In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.

In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) Secondary outcome: Thickness of buccal cortical plate In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Partial edentulous in the aesthetic zone.
• Patient with bucco-lingual bone width is 3 mm or greater but < 6mm
• Normal alveolar bone height
• Adequate oral hygiene
• Free of soft tissue or dental pathology
• Patients accepting to participate in the study

Exclusion Criteria:

• Patient medically compromised.
• Uncooperative patient.
• Poor oral hygiene and periodontal disease.
• Patients who smoked and pregnant women
• Systemic disease directly affecting bone healing
• Atrophic ridges (1.5 mm or less)
• History of radiotherapy & treatment with bisphosphonates.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: computer guided; Group (A): comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent. .	Procedure: Computer guided surgical cutting guide; comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent
Active Comparator: conventional; Group (B) comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique	Procedure: Conventional alveolar ridge splitting; comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm)	up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of buccal cortical plate	In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)	up to 4 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: horizontal defect, Anterior maxillary
• Other Study ID Numbers: 152018

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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