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Maxillary Sinus Elevation and Simultaneous Implant Placement

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03252366
Enrollment
18
Registered
2017-08-17
Start date
2016-04-30
Completion date
2017-09-30
Last updated
2017-08-17

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

Conditions

Maxillary Sinus

Keywords

MAXILLARY SINUS ELEVATION ,Simultaneous implant placement

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.

Detailed 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 .

Interventions

DEVICEGELFOAM

* 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.

DEVICExenograft

* 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of bone gained:6 monthusing linear measurements from Cone beam computed tomography

Outcome results

None listed

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