Back to resultsRadiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (RCT)
Primary Purpose
Evaluations, Diagnostic Self
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Using of hydraulic lifter device for closed sinus lifting
patient satisfaction evaluation after using hydraulic lifter device
Sponsored by
About this trial
This is an interventional treatment trial for Evaluations, Diagnostic Self
Eligibility Criteria
Inclusion Criteria:
- Edentulous patients in the maxillary posterior region .
- Patients in need to fixed restorations in posterior region .
- Patients with a healthy systemic conditions.(Apparently medically free)
- Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
- Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
- Both sexes.
- Patients with Good oral hygiene
- Patients more than 20 years old
- Cooperative and motivated patients
Exclusion Criteria:
- Patients with local pathological defects related to posterior maxilla .
- Heavy smokers.
- Abnormal habits that may alter results such as alcoholism or parafuctional habits .
- Patients with systemic diseases that may affect normal healing.
- Patients with psychiatric problem
- Patients with history of recent radiation therapy to the head and neck area .
- Patients with aggressive periodontitis .
Sites / Locations
- Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Using of bone osteotomes for closed sinus lifting
Patient satisfaction evaluation after using bone osteotomes
Arm Description
Using of summers' osteotome technique by bone osteotomes for closed sinus lifting then evaluation the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement in posterior edentulous maxilla .
Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in posterior edentulous maxilla
Outcomes
Primary Outcome Measures
Amount of bone height change
Evaluation of the amount of bone height change radiographically after closed sinus lift simultaneously with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla
Secondary Outcome Measures
Patient satisfaction numerical questionnaire
Evaluation of patient satisfaction by using specific numerical questionnaire which depends on numerical scale after closed sinus lifting procedure with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla .
The patient satisfaction numerical questionnaire include several questions to the patient and the patient will put a circle sign on the mark at which he or she feels to represent the answer .
The numerical scale is from 1 to 5 for each question (with total of 20 questions) :
represents strongly disagree
represents disagree
represents neither agree or disagree
represents agree
represents strongly agree
The final score is out of 100 so, more higher scores represents more patient satisfaction and so, better outcome and less scores represents less patient satisfaction and so, worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04648514
Brief Title
Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (RCT)
Official Title
Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT)
Detailed Description
Evaluation will be done on the amount of bone height gain radiographically (using both panorama and CBCT) after placement of the dental implant simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in patients with posterior edentulous maxilla (Randomized Clinical Trial)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluations, Diagnostic Self
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Using of bone osteotomes for closed sinus lifting
Arm Type
Active Comparator
Arm Description
Using of summers' osteotome technique by bone osteotomes for closed sinus lifting then evaluation the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement in posterior edentulous maxilla .
Arm Title
Patient satisfaction evaluation after using bone osteotomes
Arm Type
Active Comparator
Arm Description
Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in posterior edentulous maxilla
Intervention Type
Procedure
Intervention Name(s)
Using of hydraulic lifter device for closed sinus lifting
Intervention Description
Using of recent closed minimally invasive technique (hydraulic left technique) by hydraulic lifter device for closed sinus lifting then evaluation of the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement for patients with posterior edentulous maxilla .
Intervention Type
Behavioral
Intervention Name(s)
patient satisfaction evaluation after using hydraulic lifter device
Intervention Description
Evaluation of patient satisfaction numerically will be done after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
Primary Outcome Measure Information:
Title
Amount of bone height change
Description
Evaluation of the amount of bone height change radiographically after closed sinus lift simultaneously with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction numerical questionnaire
Description
Evaluation of patient satisfaction by using specific numerical questionnaire which depends on numerical scale after closed sinus lifting procedure with implant placement using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla .
The patient satisfaction numerical questionnaire include several questions to the patient and the patient will put a circle sign on the mark at which he or she feels to represent the answer .
The numerical scale is from 1 to 5 for each question (with total of 20 questions) :
represents strongly disagree
represents disagree
represents neither agree or disagree
represents agree
represents strongly agree
The final score is out of 100 so, more higher scores represents more patient satisfaction and so, better outcome and less scores represents less patient satisfaction and so, worse outcome.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Edentulous patients in the maxillary posterior region .
Patients in need to fixed restorations in posterior region .
Patients with a healthy systemic conditions.(Apparently medically free)
Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
Both sexes.
Patients with Good oral hygiene
Patients more than 20 years old
Cooperative and motivated patients
Exclusion Criteria:
Patients with local pathological defects related to posterior maxilla .
Heavy smokers.
Abnormal habits that may alter results such as alcoholism or parafuctional habits .
Patients with systemic diseases that may affect normal healing.
Patients with psychiatric problem
Patients with history of recent radiation therapy to the head and neck area .
Patients with aggressive periodontitis .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Abdelghany, PHD
Organizational Affiliation
Assoc.professor of oral and maxillofacial surgery
Official's Role
Study Director
Facility Information:
Facility Name
Cairo university
City
Giza
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (RCT)
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