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OpenTrials
Completed

NCT Number: NCT06811337

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Sinus Elevation

Procedure

Open Sinus Elevation

Closed Sinus Elevation

Procedure

Closed Sinus Elevation

Primary outcomes

  1. Mesial and Distal marginal bone loss

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Collaborators

  • Suez Canal University

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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