Completed

NCT Number: NCT04720495

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

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

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Key information

Conditions

Maxillary Ridge Augmentation

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One stage ridge splitting with simultaneous implant placement

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 with implant placement

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

Primary outcomes

Change in bone density buccal to the implant

Time frame: baseline and 4 months

Bone density was evaluated by CBCT
Change in bone width gain at the undercut area

Time frame: baseline and 4 months

Bone width gain was evaluated by CBCT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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)

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jan 22, 2021
Registry last updated: Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.