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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02449707
Enrollment
20
Registered
2015-05-20
Start date
2015-04-30
Completion date
2016-08-31
Last updated
2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

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.

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.

Interventions

PROCEDURELateral Window Technique Augmentation for Maxillary Sinus

Maxillary sinus augmentation will be performed using the lateral window technique

DEVICEUltrasound 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

DEVICEPurus® Cancellous Allograft

Allograft material placed in the sinus to acheive sinus augmentation

DEVICEResorb X Membrane

The membrane placed over the graft material before placement of the ultrasound activated pins

DEVICEBiomend

Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used

PROCEDURECone Beam CT image of the Sinus

Cone beam CT will used to assess the thickness of bone formation after the placement of the graft

PROCEDURETrephine Biopsy

Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed

Sponsors

King Saud Medical City
CollaboratorOTHER_GOV
Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in bone thickness (in mm)Change from Baseline thickness in 6 months

Secondary

MeasureTime 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 biopsy1 year

Countries

Saudi Arabia

Contacts

Primary ContactSharat Pani, MDS
sharat@riyadh.edu.sa+966544981300
Backup ContactDeema AlDhubaiban, BDS
dema.h.aldhubian@student.riyadh.edu.sa+966554157527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026