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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04648514
Other study ID # 7920
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2021

Study information

Verified date November 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date September 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Using of hydraulic lifter device for closed sinus lifting
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 .
Behavioral:
patient satisfaction evaluation after using hydraulic lifter device
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

Locations

Country Name City State
Egypt Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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.
6 months
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