Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449707
Recruitment Status : Unknown
Verified May 2015 by Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy.
Recruitment status was:  Recruiting
First Posted : May 20, 2015
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
King Saud Medical City
Information provided by (Responsible Party):
Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: Lateral Window Technique Augmentation for Maxillary Sinus Device: Ultrasound activated resorbable poly-D-L-lactide pins Device: Purus® Cancellous Allograft Device: Resorb X Membrane Device: Biomend Procedure: Cone Beam CT image of the Sinus Procedure: Trephine Biopsy Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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: 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 Name: Sonic Weld

Device: Purus® Cancellous Allograft
Allograft material placed in the sinus to acheive sinus augmentation

Device: Resorb X Membrane
The membrane placed over the graft material before placement of the ultrasound activated pins

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




Primary Outcome Measures :
  1. Change in bone thickness (in mm) [ Time Frame: Change from Baseline thickness in 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449707


Contacts
Layout table for location contacts
Contact: Sharat Pani, MDS +966544981300 sharat@riyadh.edu.sa
Contact: Deema AlDhubaiban, BDS +966554157527 dema.h.aldhubian@student.riyadh.edu.sa

Locations
Layout table for location information
Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy Recruiting
Riyadh, Saudi Arabia
Contact: Sharat C Pani, MDS       sharat@riyadh.edu.sa   
Sub-Investigator: Sharat C Pani, MDS         
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
King Saud Medical City
Investigators
Layout table for investigator information
Study Chair: Bishi AlGarni, MSc Riyadh Colleges of Dentistry and Pharmacy

Layout table for additonal information
Responsible Party: Dr Sharat Pani, Assistant Professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02449707     History of Changes
Other Study ID Numbers: FRP/2014/109
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases