- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05495490
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Omneya M. Elkadi, Ass.Lecturer
- Phone Number: 00201121844448
- Email: ninielkadi@gmail.com
Study Locations
-
-
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Assiut, Egypt, 71517
- Recruiting
- Faculty of Dentistry- Assiut University
-
Contact:
- Omneya M. Elkadi, Ass.Lecturer
- Phone Number: 00201121844448
- Email: ninielkadi@gmail.com
-
Cairo, Egypt, 11566
- Recruiting
- Faculty of Dentistry- Ain Shams University
-
Contact:
- Omneya M. Elkadi, Ass.Lecturer
- Phone Number: 00201121844448
- Email: ninielkadi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
2. Both sexes will be selected males and females.
3. Adult patients aged between 18 and 40 years of age.
4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
6. No previous surgery or radiation treatment on the maxillary sinus.
Exclusion Criteria:
1. Smokers.
2. Pregnant or lactating females.
3. Psychiatric disorders.
4. Uncontrolled systemic disease.
5. Hematologic diseases and coagulation disorders.
6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.
7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Osseodensification Internal Sinus Lift / Sticky Bone graft material
Osseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.
|
The osteotomy for the Osseodensification internal sinus lift begins with the advancement of a twist drill at 800 rpm and saline irrigation to within 1-2 mm of the sinus floor.
The osteotomy is then widened by employing a series of osteotomy drills rotating at 800 rpm.
Infracture of the sinus has occurred when the final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation ("haptic feedback") occurs.
After infracture, the graft material will be injected into the osteotomy site.
Using the final osteotomy drill, the graft is guided apically.
This procedure is repeated incrementally to raise the membrane.
Once sufficient space has been created beneath the antral membrane, the implant will be inserted followed by suturing.
|
ACTIVE_COMPARATOR: Osteotome Internal Sinus Lift /Sticky Bone graft material
Osteotome Internal Sinus Lift will be performed using sticky bone as a graft material.
|
The osteotomy for the Osteotome internal sinus lift will begin with standard drills and saline irrigation to prepare the implant socket with a working length that is 1-2 mm shorter than the residual bone height as determined by radiographic examination.
After preparation, a series of osteotomes of varying diameters will be sequentially utilized to widen the osteotomy and elevate the Schneiderian membrane by vertical tapping to create a "greenstick" fracture.
The Valsalva maneuver (nasal blowing test) will be performed to determine the integrity of the Schneiderian membrane.
During the osteotomy, the graft material will be injected and slowly placed into the elevated space using osteotomes until the desired depth is reached.
Implant placement and suturing will conclude the procedure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).
Time Frame: Pre-operative and Immediately post-operative.
|
The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.
|
Pre-operative and Immediately post-operative.
|
Radiographic Assessment of Change in the Bone Density.
Time Frame: Pre-operative and Immediately post-operative.
|
The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.
|
Pre-operative and Immediately post-operative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.
Time Frame: During procedure.
|
The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters. ( low torque (<30), medium torque (30 < Insertion Torque < 50), and high torque (>50). |
During procedure.
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Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.
Time Frame: During procedure.
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The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .
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During procedure.
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Patient's Post-Operative Pain Assessment
Time Frame: 1 week post-operative
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The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)
|
1 week post-operative
|
Patient's Satisfaction Assessment.
Time Frame: 1 week post-operative
|
The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.
|
1 week post-operative
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Operator's Satisfaction Assessment
Time Frame: 1 year
|
The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hala A. Abuel- Ela, Professor, Faculty of Dentistry- Ain Shams University
- Study Director: Mohamed W. Bissar, Lecturer, Faculty of Dentistry- Ain Shams University
- Principal Investigator: Omneya M. Elkadi, Faculty of Dentistry- Ain Shams University
Publications and helpful links
General Publications
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
- Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
- Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.
- Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
- Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenco ES, Leite PEC, Mourao CFAB, Sohn DS, Calasans-Maia MD. "Sticky Bone" Preparation Device: A Pilot Study on the Release of Cytokines and Growth Factors. Materials (Basel). 2022 Feb 16;15(4):1474. doi: 10.3390/ma15041474.
- Zhou X, Hu XL, Li JH, Lin Y. Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. Chin J Dent Res. 2017;20(4):211-218. doi: 10.3290/j.cjdr.a39220.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- FDASU-Rec ID032230
- 1120 (Ain Shams University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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.
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