Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing (RCT)

Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)

Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain

Study Overview

• Status: Completed
• Conditions: Bone Density, Low
• Intervention / Treatment: Procedure: internal sinus lift surgery

Detailed Description

Objectives: This study was directed to compare the outcomes of internal sinus lifting between osseodensification approach and piezoelectric surgery approach on the primary stability and osseointegration of dental implant.

Background data: Successful osseointegration considered the cornerstone in implant sta-bility which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone surrounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain.

Materials and Methods: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to determine implant stability by recording the values of implant stability quotient (ISQ) immediately after implant placement and after 3 months. CBCT was performed before, after 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 , 12 months via CBCT.

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

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 0000
      • Alazhar university ,Assuit branch ,Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

free of systemic disease bone height at the site of the implant is ≤ 6 mm. have good oral hygiene.

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Exclusion Criteria:

systemic diseases active periodontal disease , limited mouth-opening ability maxillary sinus disease or previous sinus surgery were also excluded smokers pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Densah Bur; patients received dental implant using osseodensification via Densah bur	Procedure: internal sinus lift surgery; surgery approach
Experimental: Group piezoelectric; patients received dental implant using hydrodynamic piezoelectric sinus lifting	Procedure: internal sinus lift surgery; surgery approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability using the Osstell device by percentage	Primary implant stability (ISQ)	baseline ,3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm	Clinical evaluation	3,6,9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Densityby mm	Crestal Bone Loss (CBL)	3,6,12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Khalid s Hassan, Dean of Badr University, Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt; Study Director: Ibrahim Hammad Ibrahim, lecturer, Alazhar University

Publications and helpful links

Helpful Links

• Orchid
• researchgate
• web of science

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Osseointegration; Dental implant; piezoelectric; primary implant stability; , internal sinus lifting; osseodensification,
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: AUAREC20220002-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Comparing the Hydrodynamic Piezoelectric Technique with Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
• IPD Sharing Time Frame: 1 month
• IPD Sharing Access Criteria: DOI:10.21203/rs.3.rs-4132878/v1
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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