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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Marginal Bone Levels Open Sinus Elevation Closed Sinus Elevation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Lateral Sinus Elevation

Group Type EXPERIMENTAL

Open Sinus Elevation

Intervention Type PROCEDURE

Open Sinus Elevation

Transcrestal Sinus Elevation

Group Type ACTIVE_COMPARATOR

Closed Sinus Elevation

Intervention Type PROCEDURE

Closed Sinus Elevation

Interventions

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Open Sinus Elevation

Intervention Type PROCEDURE

Closed Sinus Elevation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes