Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement

July 16, 2019 updated by: Mohammed Ahmed Ali Abdulkhaleq Al-dubai, Cairo University

Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial

Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates.

Description of Sandwich Osteotomy procedure to be done:

  • A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa.
  • The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing.
  • With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues.
  • The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone.
  • The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range from 20-55 years. No sex predilection.
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
  • Normal vertical dimension with increased inter-arch space.
  • The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.

Exclusion Criteria:

  • • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
  • Previous grafting procedures in the edentulous area.
  • Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sandwich osteotomy with simultaneous implant placement
This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft.
Procedure: Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement

Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:

  • The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed.
  • The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
  • Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.
Other Names:
  • Inlay alveolar bone grafting with simultaneous implant placement
ACTIVE_COMPARATOR: Sandwich osteotomy using micro-plates fixation
This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft.
Procedure: Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation

Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:

  • The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
  • The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws.
  • Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Vertical Alveolar ridge height
Time Frame: 4 months postoperatively
Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
4 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction: scale from 1 to 10
Time Frame: 4 months postoperatively
Measured on a scale from 1 to 10
4 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohammed Aldubai, Master's Degree Candidate at Faculty of Dentistry, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2019-05-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alveolar Bone Resorption

Clinical Trials on Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe