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

NCT06811337 | Completed Phase 4

• 1 other identifier: 2021/419
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Marginal Bone Levels; Open Sinus Elevation; Closed Sinus Elevation

Keywords

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

Outcome Measures

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.

  3 years

Study Arms (2)

Lateral Sinus Elevation

EXPERIMENTAL

Procedure: Open Sinus Elevation

Transcrestal Sinus Elevation

ACTIVE COMPARATOR

Procedure: Closed Sinus Elevation

Interventions

Open Sinus Elevation PROCEDURE

Open Sinus Elevation

Lateral Sinus Elevation

Closed Sinus Elevation PROCEDURE

Closed Sinus Elevation

Transcrestal Sinus Elevation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr International University: lead
• Suez Canal University: collaborator

Study Sites (1)

Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer - Oral & Maxillofacial Surgery Department

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)