Change in Mandibular Bone Width Using Two Stages Splitting Approach

Evaluation of Bone Width Change Using a Two-stage Ridge Splitting Approach in Narrow Posterior Mandibular Ridge (Clinical Trial)

Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.

Study Overview

• Status: Completed
• Conditions: Narrow Mandibular Ridge
• Intervention / Treatment: Procedure: 2-stage ridge splitting

Detailed Description

Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients aged 18-60 years old with no gender predilection.
• Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
• that requires dental implantation.
• Minimum bone width of 3 mm
• Minimum bone height of 10 mm
• Proper inter-occlusal space

Exclusion Criteria:

• Uncontrolled diabetes.
• Heavy smokers.
• Current chemotherapy or radiotherapy.
• Alcohol or drug abuse.
• Pregnant women.
• Active infection.
• Inter-occlusal space not less than 7-8 mm.
• Parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2-stage ridge splitting with simultaneous implant placement	Procedure: 2-stage ridge splitting; two-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the width of the alveolar bone	using CBCT the width were measured	at the 1st week and the 4th month
Bone density	using CBCT the bone width were measured	at the 4th week

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman
• Investigators: Principal Investigator: Ahmed M Eid, BDS, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Narrow mandibular ridge

Drug and device information, study documents

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