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CompletedNCT03401554Updated Jan 17, 2018

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

An interventional study of titanium mesh and collagen membrane in Edentulous; Alveolar Process, Atrophy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulous; Alveolar Process, Atrophy

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    collagen membrane group

    Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane

    Procedure: collagen membrane

  • Experimental
    titanium mesh group

    Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh

    Procedure: titanium mesh

Interventions

  • Proceduretitanium mesh

    closing the lateral window for maxillary sinus floor elevation with titanium mesh

  • Procedurecollagen membrane

    closing the lateral window for maxillary sinus floor elevaion with collagen membrane

05

What researchers measure

Primary outcomes

  1. bone height

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

    Time frame: 6 months

06

Study locations

1 site
  • Faculty of Dentistry, Cairo University
    Cairo, الجيزة, Egypt
07

Registry details

Key details

Study ID
NCT03401554
Lead sponsor
Cairo University
Responsible party
mostafa mahmoud abd el fattah (Dentist, Cairo University) — Principal investigator
First posted
Jan 17, 2018
Start date
May 13, 2017
Primary completion
Nov 22, 2017
Completion
Dec 17, 2017
Last update
Jan 17, 2018

Study contacts

Mostafa Mahmoud, Bds
principal investigator · Study principal investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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