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)

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04648514

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Evaluations, Diagnostic Self	Procedure: Using of hydraulic lifter device for closed sinus lifting Behavioral: patient satisfaction evaluation after using hydraulic lifter device	N/A

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Using of bone osteotomes for closed sinus lifting 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 .	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 .
Active Comparator: Patient satisfaction evaluation after using bone osteotomes Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in 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

Arm

Intervention/Treatment

Active Comparator: Using of bone osteotomes for closed sinus lifting

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 .

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 .

Active Comparator: Patient satisfaction evaluation after using bone osteotomes

Evaluation of patient satisfaction numerically will be done after using summers' osteotome technique by bone osteotomes for closed sinus lifting in 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

Outcome Measures

Primary Outcome Measures

Amount of bone height change [6 months]
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 [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Giza		Egypt	12613

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Hassan Abdelghany, PHD, Assoc.professor of oral and maxillofacial surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hassan Mohammad, Associate Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04648514

Other Study ID Numbers:

7920

First Posted:

Dec 1, 2020

Last Update Posted:

Dec 1, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mouth, Edentulous

Study Results

No Results Posted as of Dec 1, 2020