NCT05779345

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

March 10, 2023

Last Update Submit

December 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • crestal bone level

    crestal bone level will be assessed by periapical standardized radiographs

    1 year

Study Arms (2)

short implants

ACTIVE COMPARATOR

short 6 mm straumann blx implants

Procedure: surgery

regular length + internal sinus lift

ACTIVE COMPARATOR

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

Procedure: surgery

Interventions

surgeryPROCEDURE

short implant placement

regular length + internal sinus liftshort implants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Greater Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Hani El Nahass, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Suzy Naiem, MSc

CONTACT

Hani El Nahass, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

March 2, 2023

Primary Completion

April 2, 2025

Study Completion

July 2, 2025

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations