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

From the registry’s dates

Registered 7 months after the study started (first participant enrolled May 2017, registered Jan 2018).

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

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.

Conditions studied

Edentulous; Alveolar Process, Atrophy

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In context

Mouth, Edentulous

124 studies on the registry are indexed under Mouth, Edentulous; 17 are open to participants now.

This study's enrollment of 40 is above the median of 36 across 93 interventional studies indexed under Mouth, Edentulous.

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Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

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

What researchers measure

Primary outcomes

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

Study locations

1 site

Faculty of Dentistry, Cairo University
Cairo, الجيزة, Egypt

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Nov 2017, 6 months.

Of 46 non-industry interventional studies with no phase under Mouth, Edentulous, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 6 months is below that.

Counting every sponsor, half of 54 studies reached it within 24 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 6, 2018
First posted: Jan 17, 2018
StartActual: May 13, 2017
Primary completionActual: Nov 22, 2017
CompletionActual: Dec 17, 2017
Last update: Jan 17, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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 ↗

Not currently enrolling

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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Discussion

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