Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03401554
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

Condition or Disease	Intervention/Treatment	Phase
Edentulous; Alveolar Process, Atrophy	Procedure: titanium mesh; Procedure: collagen membrane	N/A

Detailed Description

this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Titanium Mesh Versus Collagen Membrane for Closure of Lateral Window Approach in Maxillary Sinus Floor Elevation With Simultaneous Implant Placement. Randomized Controlled Clinical Trial
• Actual Study Start Date: May 13, 2017
• Actual Primary Completion Date: Nov 22, 2017
• Actual Study Completion Date: Dec 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: collagen membrane group Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane	Procedure: collagen membrane; closing the lateral window for maxillary sinus floor elevaion with collagen membrane
Experimental: titanium mesh group Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh	Procedure: titanium mesh; closing the lateral window for maxillary sinus floor elevation with titanium mesh

Outcome Measures

Primary Outcome Measures

1. bone height [6 months]

   Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Cairo University	Cairo	الجيزة	Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Mostafa Mahmoud, Bds, Study principal investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mostafa mahmoud abd el fattah, Dentist, Cairo University
• ClinicalTrials.gov Identifier: NCT03401554
• Other Study ID Numbers: CEBC.CU6.1.2018
• First Posted: Jan 17, 2018
• Last Update Posted: Jan 17, 2018
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrophy

Study Results

No Results Posted as of Jan 17, 2018