Back to resultsClinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (RCT)
Primary Purpose
Evaluations, Diagnostic Self
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydrolic lifter device
Patient satisfaction evalution 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 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 parafunctional 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
summers' osteotome technique for closed sinus lift
Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique
Arm Description
Implant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla
Will be assessed numerically using a patient satisfaction chart . Time of assessment: immediately after surgery
Outcomes
Primary Outcome Measures
Implant stability evaluation
Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique
Secondary Outcome Measures
Patient satisfaction evaluation
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
NCT04659720
Brief Title
Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (RCT)
Official Title
Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
November 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
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (RCT)
Detailed Description
Clinical evaluation of stability of dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summer's osteotome technique in posterior edentulous maxilla (Randomised 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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
summers' osteotome technique for closed sinus lift
Arm Type
Active Comparator
Arm Description
Implant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla
Arm Title
Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique
Arm Type
Active Comparator
Arm Description
Will be assessed numerically using a patient satisfaction chart .
Time of assessment: immediately after surgery
Intervention Type
Device
Intervention Name(s)
Hydrolic lifter device
Intervention Description
evaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device
Intervention Type
Behavioral
Intervention Name(s)
Patient satisfaction evalution using hydraulic lifter device
Intervention Description
patients satisfaction will be evaluated numerically after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
Primary Outcome Measure Information:
Title
Implant stability evaluation
Description
Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique
Time Frame
Immediately after surgery
Secondary Outcome Measure Information:
Title
Patient satisfaction evaluation
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
Immediately after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 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 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 parafunctional 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Up till now the strategy of sharing isnot decided
Learn more about this trial
Clinical Evaluation of Stability of Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summer's Osteotome Technique in Posterior Edentulous Maxilla (RCT)
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