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

Assessment of Vertical Bone Augmentation Using Autogenous Onlay Versus Inlay Grafting Techniques With Simultaneous Implant Placement in the Anterior Maxillary Area on Patient's Esthetic Satisfaction : A Randomized Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Bone Resorption
• Intervention / Treatment: Other: assigned intervention

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

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Other: 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.
Active Comparator: 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; * 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
crestal bone loss	crestal bone loss around the implant will be measured in millimeter after 6 months	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: CairoAMI-CG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: assessment of vertical ridge augmentation using autogenous Onlay versus Inlay Bone Grafting techniques in the anterior maxilla.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No