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)

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)

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)

Study Overview

• Status: Unknown
• Conditions: Evaluations, Diagnostic Self
• Intervention / Treatment: Procedure: Using of hydraulic lifter device for closed sinus lifting; Behavioral: patient satisfaction evaluation after using hydraulic lifter device

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hassan Abdelghany, PHD, Assoc.professor of oral and maxillofacial surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 7920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No