Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed .

NCT06265467 | Completed DMC

• 1 other identifier: 28909108800228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.

Conditions

Alveolar Ridge Augmentation; Sinus Floor Augmentation; Maxillary Sinus

Keywords

Dental Implant; Maxillary Sinus Augmentation; Sinus Elevation; Open Sinus Elevation; Closed Sinus Elevation

Outcome Measures

Primary Outcomes (1)

• Implant Stability

  Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA

  immediate postoperative- 9 months- 12 months

Secondary Outcomes (1)

• Radiographic bone gain

  immediate post-operative- 6 months-12 months

Study Arms (2)

Test Group- Closed Sinus elevation

EXPERIMENTAL

Maxillary sinus floor elevation using osteotomes through a crestal approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement.

Procedure: Closed Sinus Elevation

Control Group- Open sinus elevation

ACTIVE COMPARATOR

Maxillary sinus floor elevation using sinus elevation tools through a lateral window approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement.

Procedure: Open Sinus Elevation

Interventions

Closed Sinus Elevation PROCEDURE

using a unique design of osteotomes to crestally elevate the Schneiderian membrane of the maxillary sinus floor

Also known as: Crestal approach to elevate the maxillary sinus membrane, Osteotome Technique

Test Group- Closed Sinus elevation

Open Sinus Elevation PROCEDURE

using a unique design of sinus elevators to laterally elevate the Schneiderian membrane of the maxillary sinus floor

Also known as: Lateral Approach to elevate the maxillary sinus Membrane

Control Group- Open 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, 41522, Egypt

Location

Study Officials

• Mohamed Elsholkamy, Professor

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: it is a double blinded study, both the outcome assessor and statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)