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RecruitingNCT05779345Updated Dec 15, 2023

Stability of Short Implants Versus Standard Blx Implants With Internal Sinus Floor Elevation in Posterior Maxilla

An interventional study of surgery in Bone Resorption, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.

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

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand \& Tassos Irinakis, 2007). In order to overcome these shortcomings, various procedures have been advocated including open and closed sinus lift (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003). The use of short implants is a valid alternative for these procedures (Wallace SS \& Froum SJ, 2003) sparing the need of applying augmentation techniques with the associated increased time, morbidity and complexity of such procedures.

Read the detailed description

To overcome anatomical and physiological limitations, different sinus augmentation techniques with immediate or delayed (6-8 months post augmentation) implant placement have been proposed. The most common one is the sinus elevation with a lateral window approach. Although these protocols evoke a high level of success in augmenting the bone quantity (Nkenke E \& Stelzle F, 2009; Schropp et al, 2003) many patients refuse them because of the invasiveness of the augmentative procedure, with obvious prolonged healing times and increased morbidity and costs (Fugazzotto, 2003; Bra¨gger et al, 2004; Toffler, 2004). An alternative therapy for restoring areas of limited bone dimension is the placement of short implants (Wallace SS \& Froum SJ, 2003). ''Standard length implants'' are those of 10 mm in length and have been defined as the minimal length for anticipated success (Griffin TJ \& Cheung WS, 2004).

02

Conditions studied

  • Bone Resorption

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03

In context

Bone Resorption

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's planned enrollment of 42 is above the median of 24 across 146 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

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.

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

04

Who can participate

Ages eligible
18 Years to 60 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

  • Single edentuolous site at maxillary posterior region
  • The available bone height below the maxillary sinus should be 7-8mm
  • Patients ≥ 20 years old
  • Bucco-palatal bone width should be ≥6mm
  • Adequate interarch space
  • Bounded, single

Exclusion criteria

Exclusion Criteria:

  • Patients with local pathological defects related to the area of interest.
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
  • Inadequate inter-arch space for implant prosthetic part
  • Smokers
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    short implants

    short 6 mm straumann blx implants

    Procedure: surgery

  • Active comparator
    regular length + internal sinus lift

    regular length implant 10 mm, in addition to internal sinus lift procedure

    Procedure: surgery

Interventions

  • Proceduresurgery

    short implant placement

06

What researchers measure

Primary outcomes

  1. crestal bone level

    crestal bone level will be assessed by periapical standardized radiographs

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

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

Started Mar 2023 (actual). Primary completion is estimated for Apr 2025, 25 months after the start.

Of 82 non-industry interventional studies with no phase under Bone Resorption, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 25 months is close to that.

Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 35.

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

Registered
Mar 10, 2023
First posted
Mar 22, 2023
StartActual
Mar 2, 2023
Primary completionEst.
Apr 2, 2025
CompletionEst.
Jul 2, 2025
Last update
Dec 15, 2023
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 Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05779345
Lead sponsor
Cairo University
Responsible party
Hani Elnahass (Professor, Cairo University) — Principal investigator
First posted
Mar 22, 2023
Start date
Mar 2, 2023
Primary completion
Apr 2, 2025 (estimated)
Completion
Jul 2, 2025 (estimated)
Last update
Dec 15, 2023

Study contacts

Suzy Naiem, MSc
Contact
suzy.naiem@gmail.com
+201224785645
Hani El Nahass, Professor
Contact
hani.elnahass@dentistry.cu.edu.eg
+201000252603
Hani El Nahass, Professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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