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

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04022538
• Other study ID #: CEBD-CU-2019-05-27
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: August 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Evidence-based Dentistry Committe at OMFS dept.
• Phone: +201001932020
• Email: surgeryeb[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final Vertical Alveolar ridge height	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	Patient Satisfaction: scale from 1 to 10	Measured on a scale from 1 to 10	4 months postoperatively