One-stage Versus Two-stage Inverted U-shaped Ridge Splitting

One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)

Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.

The participants were randomly allocated using a computer system into two groups:

Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.

Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.

Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography

Study Overview

• Status: Completed
• Conditions: Maxillary Ridge Augmentation
• Intervention / Treatment: Procedure: One stage ridge splitting with simultaneous implant placement; Procedure: Two-stage ridge splitting with implant placement

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

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Adult patients (20-45) years of age with no sex predilection
• At least one tooth missing in the anterior maxilla
• The presence of a labial undercut >2 mm in thickness which is not able to house an implant
• The presence of adequate bone width near the alveolar bone crest
• The absence of a vertical bone defect.

Exclusion criteria

• History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
• Pregnancy or lactation.
• Long-term amino-bisphosphonate therapy.
• Smoking more than 10 cigarettes per day.
• Alcohol or drug abuse.
• Uncontrolled periodontal disease.
• Active infection.
• Inadequate inter-incisal space.
• Bruxism or clenching.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One stage ridge splitting	Procedure: One stage ridge splitting with simultaneous implant placement; A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally. An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device. The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm. The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area. The released bone end was minimally elevated using a periosteotome through a greenstick fracture. All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure.
Experimental: Two-stage ridge splitting	Procedure: Two-stage ridge splitting with implant placement; The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed. A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply. The implants will be placed in the same manner as one stage ridge splitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone density buccal to the implant	Bone density was evaluated by CBCT	baseline and 4 months
Change in bone width gain at the undercut area	Bone width gain was evaluated by CBCT	baseline and 4 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Ridge_splitting

Drug and device information, study documents

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