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

NCT02449707 | Unknown Phase 4

• 1 other identifier: FRP/2014/109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• Change in bone thickness (in mm)

  Change from Baseline thickness in 6 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

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; Device: Purus® Cancellous Allograft; Device: Biomend; Procedure: Cone Beam CT image of the Sinus; Procedure: Trephine Biopsy

Ultrasonic Pins

EXPERIMENTAL

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; Device: Ultrasound activated resorbable poly-D-L-lactide pins; Device: Purus® Cancellous Allograft; Device: Resorb X Membrane; Procedure: Cone Beam CT image of the Sinus; Procedure: Trephine Biopsy

Interventions

Lateral Window Technique Augmentation for Maxillary Sinus PROCEDURE

Maxillary sinus augmentation will be performed using the lateral window technique

Control; Ultrasonic Pins

Ultrasound activated resorbable poly-D-L-lactide pins DEVICE

The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins

Also known as: Sonic Weld

Ultrasonic Pins

Purus® Cancellous Allograft DEVICE

Allograft material placed in the sinus to acheive sinus augmentation

Control; Ultrasonic Pins

Resorb X Membrane DEVICE

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

Ultrasonic Pins

Biomend DEVICE

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

Control

Cone Beam CT image of the Sinus PROCEDURE

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

Control; Ultrasonic Pins

Trephine Biopsy PROCEDURE

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

Control; Ultrasonic Pins

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead
• King Saud Medical City: collaborator

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Bishi AlGarni, MSc

  Riyadh Colleges of Dentistry and Pharmacy

  STUDY CHAIR

Central Study Contacts

Sharat Pani, MDS

CONTACT

+966544981300; sharat@riyadh.edu.sa

Deema AlDhubaiban, BDS

CONTACT

+966554157527; dema.h.aldhubian@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 20, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

SA (1)