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

A 36 - Month Randomized Controlled Trial Comparing the Marginal Bone Changes Surrounding Dental Implants Placed With Open Versus Closed Sinus Elevation and Allogenic Bone Grafting.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06811337
Enrollment
52
Registered
2025-02-06
Start date
2022-01-01
Completion date
2025-01-15
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Sinus Elevation, Marginal Bone Levels, Open Sinus Elevation

Keywords

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

Brief 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.

Interventions

Open Sinus Elevation

Closed Sinus Elevation

Sponsors

Suez Canal University
CollaboratorOTHER
Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mesial and Distal marginal bone loss3 yearsUtilizing 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026