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

Implant Site Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446687
• Other study ID #: 99522504
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Implant Site Reaction
• Maxillary Deficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.