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CompletedNCT06811337Updated Feb 6, 2025

Marginal Bone Changes Around Dental Implant Placed With Open vs. Closed Sinus Elevation

A Phase 4 interventional study of Open Sinus Elevation and Closed Sinus Elevation in Marginal Bone Levels, Open Sinus Elevation and Closed Sinus Elevation, sponsored by Misr International University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Misr International University · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jan 2022, registered Jan 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Background: In cases with atrophic posterior maxilla, sinus elevation techniques are essential for a successful implant placement. The optimal strategy for treating pneumatized maxillary sinus in terms of dental implant insertion and surrounding bone stability has been a scientific conundrum for many years. The objective of this study was to evaluate and contrast the long-term marginal bone alterations around dental implants that were positioned utilizing transcrestal (closed) versus lateral (open) sinus elevation procedures.

Material and methods:

Fifty six dental implants were inserted for patients with inadequate residual bone height due to maxillary sinus pneumatization after receiving approval from Suez Canal University's ethics council. Depending on the method, these patients were randomly assigned to one of two groups: the test group, which received the closed sinus elevation, or the control group, which received the open sinus elevation.Allogenic bone grafting was used to treat the elevated sinuses in both groups.The mesial and distal marginal bone loss for these dental implants was evaluated over a 12-month period following surgery using a standardized digital periapical radiography and the Cliniview Software to measure radiographic bone alterations.

02

Conditions studied

  • Marginal Bone Levels
  • Open Sinus Elevation
  • Closed Sinus Elevation

Keywords

  • Dental Implants
  • Bone Loss
  • Maxillary Sinus Floor Augmentation.
  • Bone-Implant Interface
  • Bone Resorption,
03

In context

Bone Diseases, Metabolic

487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.

This study's enrollment of 52 is below the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Misr International University is the lead sponsor of 46 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
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

  • Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
  • Adults above the age of 18.
  • Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
  • Good oral hygiene.
  • Patient accepts to sign an informed consent.

Exclusion criteria

Exclusion Criteria:

  • Smokers (more than 10 cigarettes per day).
  • Medically compromised patients.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with untreated active periodontal diseases.
  • Patients with parafunctional habits.
  • Acute or chronic sinusitis.
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Lateral Sinus Elevation

    Procedure: Open Sinus Elevation

  • Active comparator
    Transcrestal Sinus Elevation

    Procedure: Closed Sinus Elevation

Interventions

  • ProcedureOpen Sinus Elevation

    Open Sinus Elevation

  • ProcedureClosed Sinus Elevation

    Closed Sinus Elevation

06

What researchers measure

Primary outcomes

  1. Mesial and Distal marginal bone loss

    Utilizing A standardized digital periapical radiography, and the Cliniview Software to measure radiographic bone changes mesially and distally to 56 implants placed after sinus elevation in the posterior maxilla.

    Time frame: 3 years

07

Study locations

1 site
  • Suez Canal University
    Ismailia, Ismailia Governorate 41522, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06811337
Lead sponsor
Misr International University
Responsible party
Hebatallah Abdo's Elsaid Mattar (Assistant Lecturer - Oral & Maxillofacial Surgery Department, Misr International University) — Principal investigator
First posted
Feb 6, 2025
Start date
Jan 1, 2022
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025
Last update
Feb 6, 2025

Oversight

Data monitoring committee
No
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 2025. You cannot join it, but the record below documents what was studied.

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