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Completed

NCT Number: NCT06285903

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

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

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Key information

Conditions

Bone Density, Low Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

35 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazhar university ,Assuit branch ,Egypt

Asyut, Assuit, 0000, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

internal sinus lift surgery

Procedure

surgery approach

Primary outcomes

  1. Implant stability using the Osstell device by percentage

    Time frame: baseline ,3 months

    Primary implant stability (ISQ)

Secondary outcomes

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

    Time frame: 3,6,9 months

    Clinical evaluation

Other outcomes

  1. Bone Densityby mm

    Time frame: 3,6,12 months

    Crestal Bone Loss (CBL)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 29, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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