- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329179
Crestal Sinus Lifting Using Densah Burs Versus Lateral Window Technique at Residual Alveolar Ridge Height 3-5 mm With Simultaneous Implant Placement
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Patient medically free from systemic, immunologic or debilitating diseases or local conditions that could affect normal bone healing and/or implant placement.
2. Patient with good oral hygiene. 3. Age from 18 to 55 years. 4. Partially edentulous patients with missed one or more of maxillary posterior teeth with residual alveolar ridge height 3-5 mm and a minimal width of the alveolar ridge 7 mm in the region of the planned implant site.
5. Patients' edentulous ridges covered with optimal width of keratinized mucosa (<3 mm) with no signs of inflammation, ulceration of scar tissue.
6. No history of parafunctional habits. 7. Patients were ready to comply with the follow-up and maintenance program. 8. Sufficient inter arch space for prothesis.
Exclusion Criteria:
- 1. Patients with clinical or radiographic evidence of rhinosinusitis or any other pathology in the maxillary sinus.
2. Smokers. 3. Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: crestal technique using densah burs
Seven implant sites underwent sinus membrane elevation procedure using densah burs with crestal approach.
Crestal flap was made and Densah bur with diameter 2.00 mm will be used in osseodensification mode with copious irrigation till sinus floor, then diameter 3.00 mm bur up to 3 mm past the sinus floor, then sequential wider burs to reach the final desired width followed by bone grafting and simultaneous implant placement.
|
|
|
Active Comparator: lateral window technique
Seven implant sites underwent sinus membrane elevation procedure using lateral window technique.
Pyramidal flap was made and an trap door is created in the lateral sinus wall to gain access to Schneiderian membrane in order to elevate it and provide space for the bone graft material to be placed followed by simultaneous implant placement.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline in pain, as measured by Numerical Rating Scale (NRS)
Time Frame: Baseline, 7 days
|
Pain was evaluated postoperatively at the day of surgery, 3rd and 7th day post-surgically Numerical Rating Scale (NRS).
Numerical Rating Scale (NRS) is a simple, widely used tool, typically an 11-point scale (0-10), where patients rate their pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain,".
|
Baseline, 7 days
|
|
change from baseline of edema
Time Frame: baseline, 7 days
|
Edema was evaluated with the aid of tape measure (in centimeters). Three measurements were performed on the patient's operated site preoperatively, 3rd and 7th day after surgery. The evaluation of edema was done by subtracting the total value of the three measurements obtained postoperatively (at 3rd and 7th day) from the total value of the three measurements obtained at pre-operative baseline. The three measuring lines are:
|
baseline, 7 days
|
|
change of implant stability, as measured by osstell
Time Frame: baseline, 12 months
|
Stability was measured with osstell (ISQ) immediately after implant placement (T0) after 12 months (T12).
ISQ is a scale that ranges from 1 to 100 and is used to assess implant stability.
Scales greater than 70 ISQ indicate a high level of stability, scales between 60 and 69 means medium stability and scales >60 ISQ are considered as low stability.
|
baseline, 12 months
|
|
change from baseline in Grafted sinus height (GSH)
Time Frame: baseline, 12 months
|
CBCT was made preoperatively, immediately after sinus augmentation (T0) and 6 months after loading (T12) for evaluation of Grafted sinus height (GSH): the distance between the original sinus floor to the new sinus floor regarding crestal cortical line.
|
baseline, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Wael Mohamed Ahmed, professor, department of oral and maxillofacial surgery, faculty of dentistry, mansoura university
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
- A02061222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sinus Pneumatization
-
Suez Canal UniversityCompleted
-
Cairo UniversityUnknown
-
NYU College of DentistryTerminatedBilateral Sinus Pneumatization | Posterior Maxillary Ridge Atrophy Due to ExtractionUnited States
-
Saint-Joseph UniversityRecruitingAlveolar Bone Loss | Sinus Floor Augmentation | Alveolar Ridge Preservation | Sinus Pneumatization | Alveolar Bone AtrophyLebanon
-
Cairo UniversityNot yet recruiting
-
Sana'a UniversityRecruitingAlveolar Bone Atrophy | Edentulous Posterior Maxilla | Maxillary Sinus PneumatizationYemen
-
Semmelweis UniversityCompletedAlveolar Bone Loss | Edentulous; Alveolar Process, Atrophy | Sinus PneumatizationHungary
-
University of MichiganBioHorizons, Inc.CompletedSinus Pneumatization | Alveolar Bone Atrophy | EdentulismUnited States
-
University of Bari Aldo MoroCompletedSinus Pneumatization | Bone Atrophy, Alveolar | EdentulismItaly
-
Elazıg Fethi Sekin Sehir HastanesiCompletedRetinal Nerve Fiber Layer Thickness | Anterior Clinoid Process Pneumatization | Optic Canal MorphometryTurkey (Türkiye)
Clinical Trials on crestal sinus lifting using densah burs
-
Cairo UniversityRecruitingBone Formation Around Implant After Crestal Sinus LiftingEgypt
-
Cairo UniversityNot yet recruiting
-
Al-Azhar UniversityCompleted
-
Ain Shams UniversityNot yet recruitingInternal Sinus LiftingEgypt
-
Faculty of Dental Medicine for GirlsCompletedLaser Effect Around Dental Implant | Implant Stability and OsseointegrationEgypt
-
Tanta UniversityEnrolling by invitationMaxillary Sinus Augmentation Using CAD/CAM Allogenic Bone Blocks Versus Particulate Allogenic GraftsMaxillary Sinus | AllograftEgypt
-
Suez Canal UniversityNot yet recruitingPatient With Low Denisty Bone
-
Cairo UniversityUnknown
-
Misr International UniversityNot yet recruiting