Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife Edge Ridge in Partially Edentulous Patients for Implant Placement

NCT03556111 | Unknown

• 1 other identifier: Sticky bone augmentation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to evaluate the value and efficiency of sticky bone in the augmentation of alveolar ridge deficiency when being used with or without xenogenic bone graft for esthetic implant placement.

Conditions

Alveolar Bone Loss; Bone Graft; Complications

Keywords

implant , sticky bone

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction with the bone gain and the prosthetic implant placement

  8 months after bone graft placement

Secondary Outcomes (2)

• bone width gain

  5 month after bone graft placement

• Successful implant placement

  5 months after bone graft placement

Study Arms (2)

anterior knife-edge maxilla graft (Without Xenograft Usage)

EXPERIMENTAL

The intervention will be a Sticky bone augmentation of defect. It is prepared using particulate autologous graft only along with fibrin glue and growth factors obtained from the patients' blood. The sample is withdrawn and placed in plastic tubes which are spun twice in a centrifuge at a certain speed and time. The first spin to obtain the fibrin glue and the second to obtain the growth factors. The mixture is added to the harvested autogenous bone to form a semi-solid bone graft that is easily manipulated in the recipient site.

Procedure: Sticky bone augmentation

anterior knife edge maxilla graft (With Xenograft Usage)

EXPERIMENTAL

The intervention will be the sticky bone augmentation of the defect using both particulate autogenous and xenograft bovine bone. The bone will be harvested from the donor, coupled with the bovine bone, the growth factors and the fibrin glue that is obtained from the patient's own blood sample. The venous blood sample is placed in plastic tubes to be centrifuged at a certain speed and time to obtain the fibrin glue and growth factors. The mixture is prepared until the bone is sticky and ready to be placed in the recipient defective maxilla

Procedure: Sticky bone augmentation

Interventions

Sticky bone augmentation PROCEDURE

1. Autogenous sticky bone augmentation for the first group 2. Autogenous sticky bone preparation with xenograft usage 3. After 5-month of bone grafting; esthetic implant placement

anterior knife edge maxilla graft (With Xenograft Usage); anterior knife-edge maxilla graft (Without Xenograft Usage)

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Alveolar bone width 3mm or less in anterior maxillary knife edge ridge as evaluated preoperatively on the CBCT
• Both sexes.
• Good oral hygiene.
• Age between 18 and 48 years. Highly motivated patients

You may not qualify if:

• \- Patient with Bad oral hygiene
• Post-menopausal females with osteoporosis
• Patient with uncontrolled systemic disease For instance: uncontrolled Diabetes Mellitus

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

School of Dentistry , Cairo University.

Cairo, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

nesma m ibrahim, BDS

CONTACT

00201000750518; nesmamattar@outlook.com

mostafa I Shindy, PHD

CONTACT

00201121112222

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: principle investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: June 14, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)