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

NCT ID: NCT04720495

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-09-30

Brief Summary

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

Conditions

Maxillary Ridge Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One stage ridge splitting

Group Type: ACTIVE_COMPARATOR

One stage ridge splitting with simultaneous implant placement

Intervention Type: PROCEDURE

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.

Two-stage ridge splitting

Group Type: EXPERIMENTAL

Two-stage ridge splitting with implant placement

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

Ridge_splitting

Identifier Type: -

Identifier Source: org_study_id