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)

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)

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)

Study Overview

• Status: Unknown
• Conditions: Evaluations, Diagnostic Self
• Intervention / Treatment: Device: Hydrolic lifter device; Behavioral: Patient satisfaction evalution using hydraulic lifter device

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: summers' osteotome technique for closed sinus lift; Implant stability will be evaluated after closed sinus lift using summer's osteotome technique in posterior edentulous maxilla	Device: Hydrolic lifter device; evaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device
Active Comparator: Patient satisfaction evaluation after closed sinus lifting using summers' osteotome technique; Will be assessed numerically using a patient satisfaction chart .; Time of assessment: immediately after surgery	Behavioral: Patient satisfaction evalution using hydraulic lifter device; patients satisfaction will be evaluated numerically 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
Implant stability evaluation	Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after surgery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hassan Abdelghany, PHD, Assoc.professor

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 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: 131020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Up till now the strategy of sharing isnot decided

Drug and device information, study documents

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