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

NCT06285903 | Completed DMC

• 1 other identifier: AUAREC20220002-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Density, Low

Keywords

Dental implant; Osseointegration; primary implant stability; , internal sinus lifting; osseodensification,; piezoelectric

Outcome Measures

Primary Outcomes (1)

• Implant stability using the Osstell device by percentage

  Primary implant stability (ISQ)

  baseline ,3 months

Secondary Outcomes (1)

• Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm

  3,6,9 months

Other Outcomes (1)

• Bone Densityby mm

  3,6,12 months

Study Arms (2)

Group Densah Bur

EXPERIMENTAL

patients received dental implant using osseodensification via Densah bur

Procedure: internal sinus lift surgery

Group piezoelectric

EXPERIMENTAL

patients received dental implant using hydrodynamic piezoelectric sinus lifting

Procedure: internal sinus lift surgery

Interventions

internal sinus lift surgery PROCEDURE

surgery approach

Group Densah Bur; Group piezoelectric

Eligibility Criteria

• Age: 35 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university ,Assuit branch ,Egypt

Asyut, Assuit, 0000, Egypt

Location

Related Links

• orchid
• researchgate
• web of science

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ibrahim Hammad Ibrahim, lecturer

  Al-Azhar University

  STUDY DIRECTOR

• Khalid s Hassan, Dean of Badr University

  Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturere of oral medicine ,periodontology departement at sphinx university

Model Details: 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 de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 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 months and after 12 months via CBCT.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 29, 2024
• Study Start: September 2, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 1 month
• Access Criteria: DOI:10.21203/rs.3.rs-4132878/v1

Locations

EG (1)