Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.

NCT ID: NCT03052387

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2017-12-31

Brief Summary

Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques.

Detailed Description

to study the vertical augmentation with simultaneous implant placement at anterior maxillary region.

• P: Patient requires implant at anterior maxillary ridge with vertical deficiency.
• I:Inlay Sandwich Technique with immediate implant placement.
• C:Onlay autogenous graft immediate implant placement.
• O:Outcome name Measuring device Measuring unit

Primary outcome: Vertical bone gain CBCT Millimeter

-Secondary outcome(a): Crestal bone loss CBCT Millimeter

Conditions

Bone Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

• Crestal pyramidal flap will be done with 2 releasing incisions for adequate exposure.
• Buccal& palatal full reflection for adequate exposure and to avoid the interference between the onlay graft and the residual bone.
• Decortication of the bone bed to increase the blood supply to the onlay graft.
• The block graft harvested from the chin is placed crestal to the residual ridge and stabilized in place using dental implant immediately.
• Periosteal incisions are usually needed to allow tension free sutures.
• Vicryl 3/0 sutures for closer.
• augmentin 1g twice daily for 5 days.
• catflam 50g twice daily for 3 days

Group Type: PLACEBO_COMPARATOR

assigned intervention

Intervention Type: OTHER

• Local anesthesia with vasoconstrictor(V.C) used for hemostasis.

chin block graft

• Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
• The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region.
• Low vestibular incision exposing the symphysis area to the inferior border of the mandible.
• Using fissure bur to harvest the graft for the defect.
• Closure using vicryl 3-O sutures.

Comparator

• Crestal incision with labial flap reflected leaving the palatal tissues without elevation.
• Marking of the 3 bony cuts ( 2 vertical cuts & 1 horizontal cut ) using fine fissure bur in the form of perforations along the cuts position.
• Drilling of pilot drill and first drill only.
• 3 full thickness cuts will be performed (2 vertical stop cuts will be made by using the tungsten carbide disc at the distal ends of the horizontal bony cut on the facial surface of alveolar ridge.
• splitting osteotomes are used and mallet to complete the splitting of the bony segment.
• After bony separation the rectangular bony segment (transport segment) will be mobilized occlusally and pedicled on the palatal mucoperiosteum.
• The autogenous block graft harvested from the chin area is placed in the space gained under the mobile bony segment.
• Drilling through the bony segment and the block graft.
• Immediate implant placement

chin graft block dental implants

Group Type: ACTIVE_COMPARATOR

assigned intervention

Intervention Type: OTHER

• Local anesthesia with vasoconstrictor(V.C) used for hemostasis.

chin block graft

• Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
• The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region.
• Low vestibular incision exposing the symphysis area to the inferior border of the mandible.
• Using fissure bur to harvest the graft for the defect.
• Closure using vicryl 3-O sutures.

Interventions

assigned intervention

• Local anesthesia with vasoconstrictor(V.C) used for hemostasis.

chin block graft

• Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
• The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region.
• Low vestibular incision exposing the symphysis area to the inferior border of the mandible.
• Using fissure bur to harvest the graft for the defect.
• Closure using vicryl 3-O sutures.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• * Patients with partially edentulous anterior maxillary ridges.

• Patients were free from any systemic disease that interferes with bone healing.
• Absence of local pathosis at anterior maxillary area.
• No history of any grafting procedure at the designated edentulous ridge.

The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space.

Exclusion Criteria

• * Patient with fully dentulous maxilla.

• Pregnant females.
• Presence of bad habits (severe bruxism, clenching).
• Systemic diseases that may interfere with bone healing.e.g. uncontrolled Diabetes.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Ahmed Hassan

Dentist at National research centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CairoAMI-CG

Identifier Type: -

Identifier Source: org_study_id