Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Using Ultrasound Activated Pins

Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Lift Using Ultrasound Activated Resorbable Poly-D-L-lactide Pins in Maxillary Sinus Lift - a Split Mouth Randomized Control Trial

Ultrasound activated pins have been used for the promotion of bone healing in combination with biodegradable membranes during bone grafting procedures. In the jaws, these pins have been successfully tested for both maxillary and mandibular ridge augmentaton. However, the usefulness of these pins in maxillary sinus lift procedures has not been tested. This study aims to use a bilateral split mouth design to compare the bone formation, healing and post-operative complications after the use of ultrasonic guided pins in a lateral window maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus augmentation procedure procedure performed without the use of these pins.

Study Overview

• Status: Unknown
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: Lateral Window Technique Augmentation for Maxillary Sinus; Device: Purus® Cancellous Allograft; Device: Biomend; Procedure: Cone Beam CT image of the Sinus; Procedure: Trephine Biopsy; Device: Ultrasound activated resorbable poly-D-L-lactide pins; Device: Resorb X Membrane

Detailed Description

The study proposes to use a prospective split mouth crossover randomized control trial design to study the success of implant placement in cases with sinus lift procedures performed using the Sonic Weld® (KLS-Martin GmbH , Mulheim, Germany) ultrasound guided bone welding system with a membrane (Resorb X Membrane) on one side, and placement of Biomend collagen membrane to stabilize the graft

Patient selection:

20 patients requiring bilateral maxillary sinus lift procedure (40 procedures) will be selected from the patients reporting for implant placement to both the Riyadh Colleges of Dentistry and Pharmacy and the Riyadh Dental Center, King Saud Medical City.

Graft Placement:

Each patient will receive both the pin stabilized and the conventional graft placement procedures with standardized allografts (Purus® Cancellous Allograft?) on both sides of the maxilla. The grafts will be placed using the lateral window technique. The patients will be randomly assigned into either those who receive the pin first (Group A) or those who receive the conventional technique (using collagen membranes) first (Group B). The patients will have a one week gap between the sinus lift on the right and left sides.

Evaluations of the sinus lift procedure:

The sinus lift will be evaluated clinically radiographically and histologically using previously established criteria. Cone Beam CTs (Gallelios Comfort plus, Sirona Dental, Salzburg, Austria) will be taken preoperatively and at three month intervals to help assess the osseous outcomes of the graft.

At the end of one year the site will be evaluated clinically for the placement of implants. At the time of placement of the implant a trephine biopsy will be performed and H&E staining will be used to determine the histological outcomes of the graft procedure.

Statistical Analysis:

The paired t test will be used to compare the thickness of bone before and after the completion of the sinus lift procedure. The multiple measures paired ANOVA will be used to compare the thickness of bone at each follow up vist.

The student's t test will be used to compare the thickness of bone between the two types of sinus lift procedure.

The chi-square test will be used to compare differences (if any) in the histological patterns obtained at the end of the study.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • Riyadh Colleges of Dentistry and Pharmacy
    • Contact: Sharat C Pani, MDS; Email: sharat@riyadh.edu.sa
    • Sub-Investigator: Sharat C Pani, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Loss of upper permanent molar on both right and left side
• Require Bilateral Maxillary Sinus Augmentation
• Consent to partipate in the study

Exclusion Criteria:

• History of Diabetes Mellitus (including patients who are controlled with oral hypoglyceamic drugs)
• Uncontrolled Hypertensive patients with three consecutive diastolic readings of over 90mmHg
• History of Osteoporosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Lateral Window Technique Augmentation for Maxillary Sinus without the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of membrane. Placement of Purus® Cancellous Allograft, stabilized by Biomend ™ Collagen membrane. Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed.	Procedure: Lateral Window Technique Augmentation for Maxillary Sinus; Maxillary sinus augmentation will be performed using the lateral window technique; Device: Purus® Cancellous Allograft; Allograft material placed in the sinus to acheive sinus augmentation; Device: Biomend; Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used; Procedure: Cone Beam CT image of the Sinus; Cone beam CT will used to assess the thickness of bone formation after the placement of the graft; Procedure: Trephine Biopsy; Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
Experimental: Ultrasonic Pins; Lateral Window Technique Augmentation for Maxillary Sinus with the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of the Purus® Cancellous Allograft, and Resorb X Membrane.Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed.	Procedure: Lateral Window Technique Augmentation for Maxillary Sinus; Maxillary sinus augmentation will be performed using the lateral window technique; Device: Purus® Cancellous Allograft; Allograft material placed in the sinus to acheive sinus augmentation; Procedure: Cone Beam CT image of the Sinus; Cone beam CT will used to assess the thickness of bone formation after the placement of the graft; Procedure: Trephine Biopsy; Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed; Device: Ultrasound activated resorbable poly-D-L-lactide pins; The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins; Other Names: Sonic Weld; Device: Resorb X Membrane; The membrane placed over the graft material before placement of the ultrasound activated pins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in bone thickness (in mm)	Change from Baseline thickness in 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Post-operative pain - as reported on a Visual Analog Scale (VAS)	Change from baseline VAS in 6 months
Bone Quality - Measured by the type of bone observed on the trephine biopsy	1 year

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Collaborators: King Saud Medical City
• Investigators: Study Chair: Bishi AlGarni, MSc, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: May 14, 2015
• First Submitted That Met QC Criteria: May 16, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 16, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: FRP/2014/109