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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

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

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
04

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

05

What researchers measure

Primary outcomes

  1. crestal bone level

    crestal bone level will be assessed by periapical standardized radiographs

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, Greater Cairo 12613, Egypt
    • Hani El Nahass, Professor · Contact
    Recruiting
07

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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