Marginal Bone Changes Around Dental Implant Placed with Open Vs. Closed Sinus Elevation

Phase 4

Completed

• Conditions: Marginal Bone Levels; Open Sinus Elevation; Closed Sinus Elevation

• Registration Number: NCT06811337
• Lead Sponsor: Misr International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mesial and Distal marginal bone loss	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.

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismalia, Ismailia, Egypt