Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge

This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting

Study Overview

• Status: Not yet recruiting
• Conditions: Implant Site Reaction; Maxillary Deficiency
• Intervention / Treatment: Procedure: Dental implant with sinus lifting.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
2. Residual bone height 4-8mm in the estimated implant positions.
3. The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
4. The edentulous ridges are covered with optimal thickness of mucoperiosteum.

Exclusion Criteria:

1. Patients with a systemically diseases or inflammation whether local or generalized.
2. Patients with bleeding disorders.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Poor oral hygiene and motivation.
5. Pregnant or nursing.
6. Severe bruxism or clenching.
7. Active infection or severe inflammation in the area intended for implant placement.
8. Unable to open mouth sufficiently to accommodate the surgical tooling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sinus Lifting by Using Crestal approach with membrane control technique.; Sinus Lifting with simultaneously implant placement.

Procedure: Dental implant with sinus lifting.; Surgery will be performed under local infiltration anaesthesia. Flap will be done. For maxillary sinus lifting by using Crestal approach with Membrane Control Technique by Wang (Wang, 2017) will be employed. After reflecting on the flap, Magic Split will be used to confirm bone quality clinically. This will be followed by site preparation using Magic Marking Drill. Bone drilling will then be performed by Magic Drill shorter by 2 mm from the sinus floor. This will be followed by sinus lifting by using Magic Sinus Lifter (MSL). The 3mm space of the apex of the Sinus Lifter instrument enables direct control of the bone-block and consequently the membrane, which is connected to the bone-block. the fixture will be installed in the conventional method. Then cover the fixture with the cover screw. The flap will be sutured. An immediate CBCT will be requested to ensure the implant is in its proper position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cone beam computed tomography (CBCT) bone height formation around dental implants	Calculate bone height and formation around dental implants.	Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cone beam computed tomography (CBCT) density formation around dental implants	Calculate bone density formation around dental implants.	Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 1, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Closed Sinus lifting; Bone Gain
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 99522504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No