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)

• Sponsor: Cairo University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04659720
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 1.6

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Evaluations, Diagnostic Self	Device: Hydrolic lifter device; Behavioral: Patient satisfaction evalution using hydraulic lifter device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Oct 27, 2020
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Nov 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Implant stability evaluation [Immediately after surgery]

   Evaluation of implant stability after closed sinus lifting in posterior edentulous maxilla using osteotome technique versus hydraulic lift technique

Secondary Outcome Measures

1. Patient satisfaction evaluation [Immediately after surgery]

   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 and Older
• 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Hassan Abdelghany, PHD, Assoc.professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hassan Mohammad, Assoc.professor in maxillo facial surgery, Cairo University
• ClinicalTrials.gov Identifier: NCT04659720
• Other Study ID Numbers: 131020
• First Posted: Dec 9, 2020
• Last Update Posted: Dec 9, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mouth, Edentulous

Study Results

No Results Posted as of Dec 9, 2020