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

NCT03052387 | Unknown

• 1 other identifier: CairoAMI-CG
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Resorption

Outcome Measures

Primary Outcomes (1)

• vertical Bone gain

  * The nasal floor will be used as a fixed reference by adjusting the cross sectional long axis in the center of the area of interest and bisecting it (showing the buccolingual dimension). * All the patients will wear the radiographic dentures with radiopaque material (barium sulphate mixed with acrylic powder) filling the teeth at the area of interest to ensure that the calculations were taken at the same region. * On the cross sectional view of CBCT and at each proposed implant site, a line will be drawn starting from the crest of the ridge till the nasal floor. The height will be recorded preoperatively, immediately (1 week) and 6 months postoperatively.the difference between them in millimeters will be recorded.

  6 months

Secondary Outcomes (1)

• crestal bone loss

  6 months

Study Arms (2)

control

PLACEBO COMPARATOR

* 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

Other: assigned intervention

Comparator

ACTIVE 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

Other: assigned intervention

Interventions

assigned intervention 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; control

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \* 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.

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist at National research centre

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: March 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share