Maxillary Sinus Elevation and Simultaneous Implant Placement

Maxillary Sinus Clinical Trial

Official title:

MAXILLARY SINUS ELEVATION USING GELFOAM (ABSORBABLE GELATIN) VERSUS XENOGRAFT (TUTOGEN) and SIMULTANEOUS IMPLANT PLACEMENT:Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03252366
• Other study ID #: MI.cairouniversity
• Status: Active, not recruiting
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 15, 2017
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

One of the main problem for posterior maxilla it becomes atrophic after extraction of the teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar process is a common reason for the limited availability of alveolar bone for implant placement in the posterior maxilla.

Numerous techniques designed to increase bone volume in the maxillary sinus region have been proposed. They were mostly based on the insertion of various materials into a void created between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges demonstrate new bone formation through clinical and radiographic evaluations. New bone formation was verified by stabilization of the elevated sinus membrane from the tenting effect of placement of dental implants and absorbable gelatin sponge without any bone graft material. This study shows that there is great potential for new bone formation in the maxillary sinus without the use of additional bone grafts. Systemic review showed that the survival rate for implants utilizing xenografts was statistically the same as for implants placed in particulate autogenous bone grafts .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:• Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height from 3 to 5mm .

• Both sexes.

• No intraoral soft and hard tissue pathology.

• No systemic condition that contraindicate implant placement.

Exclusion Criteria:• Sinus pathology.

• 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.

Related Conditions & MeSH terms

• Maxillary Sinus

Intervention

Device:
• GELFOAM
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.
• xenograft
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of bone gained:	using linear measurements from Cone beam computed tomography	6 month