Maxillary Sinus Elevation and Simultaneous Implant Placement

NCT03252366 | Unknown DMC

• 1 other identifier: MI.cairouniversity
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

using gel foam \[ absorbable gelatin \] in maxillary sinus elevation which act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus and its advantages for patients undergoing maxillary sinus elevation with simultaneous implant placement as regards the implant stability and amount of bone height gain compared to conventional maxillary sinus elevation by xenograft.

Conditions

Maxillary Sinus

Keywords

MAXILLARY SINUS ELEVATION ,Simultaneous implant placement

Outcome Measures

Primary Outcomes (1)

• Amount of bone gained:

  using linear measurements from Cone beam computed tomography

  6 month

Study Arms (2)

GELFOAM (ABSORBABLE GELATIN)

ACTIVE COMPARATOR

Sterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic. it act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids its effect appears to be more physical than the result of altering the blood clotting mechanism. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue

Device: GELFOAM

XENOGRAFT (TUTOGEN)

ACTIVE COMPARATOR

xenografts as a sinus bone replacement graft ,The osteoconductive properties of xenografts in human sinus grafting have been well documented. They are due to both their chemical composition and their macro and micro morphology.The efficacy of xenografts as a sinus bone replacement graft may be due to combination of factors. Foremost would be the osteoconductive capacity of xenografts. In addition, they supply minerals that are necessary for bone formation, their density provides stability to the graft and the implants placed in them, and this density persists long term due to the fact that these grafts do not completely resorb.

Device: xenograft

Interventions

GELFOAM DEVICE

* Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla. * A diamond bur will be used to make a rectangular osteotomy. * The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement. * Implant stability will be measured by osteal device * implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures.

Also known as: (ABSORBABLE GELATIN)

GELFOAM (ABSORBABLE GELATIN)

xenograft DEVICE

* Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla. * A diamond bur will be used to make a rectangular osteotomy. * The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement. * Implant stability will be measured by osteal device * implants will be inserted with xenograft for augmentation.• The flap will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures.

Also known as: TUTOGEN

XENOGRAFT (TUTOGEN)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both sexes.
• No intraoral soft and hard tissue pathology.
• No systemic condition that contraindicate implant placement.

You may not qualify if:

• Heavy smokers more than 20 cigarettes per day .
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems.
• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Gelatin Sponge, Absorbable; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies; Transplantation; Surgical Procedures, Operative

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: Master degree student

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08