- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922592
Different Techniques of Crestal Sinus Lift
Balloon Technique Versus Densah Bur in Crestal Sinus Lift Operation With Simultaneous Implant Placement. A Prospective Study
Sixteen patients will be selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, [premolar and molars] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.
Group I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Mohamed Mahmoud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patent ostium of maxillary sinus.
- Patient with missing one or more posterior maxillary teeth.
- A ridge height at the site of implantation of 4-7 mm.
- A ridge width at the site of implantation of 6 mm.
- Good oral hygiene.
- Patients in the age frame between 20 years and 50 years old.
- No gender preface in selection of the patients.
- Acceptable inter-arch space for the future prosthesis.
Exclusion Criteria:
- Any pathological condition at the site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge
- Disturbed occlusion.
- Maxillary sinus inflammation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
|
The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.
|
|
Experimental: The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement
|
The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height gain
Time Frame: 6 months
|
Bone height after the surgery measured on CBCT 6-months postoperative _ Residual bone height at implant placement
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A08030123
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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