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

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Completed

CT.gov ID

NCT04720495

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Maxillary Ridge Augmentation	Procedure: One stage ridge splitting with simultaneous implant placement Procedure: Two-stage ridge splitting with implant placement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in bone density buccal to the implant [baseline and 4 months]
Bone density was evaluated by CBCT
Change in bone width gain at the undercut area [baseline and 4 months]
Bone width gain was evaluated by CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT04720495

Other Study ID Numbers:

Ridge_splitting

First Posted:

Jan 22, 2021

Last Update Posted:

Jan 22, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 22, 2021