Clinical trial NCT06285903: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing
Official title: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Density, Low
Keywords: Dental implant
Osseointegration
primary implant stability
, internal sinus lifting
osseodensification,
piezoelectric
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant stability using the Osstell device by percentage
timeFrame: baseline ,3 months
Secondary outcomes:
measure: Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm
timeFrame: 3,6,9 months
Other outcomes:
measure: Bone Densityby mm
timeFrame: 3,6,12 months
Locations:
city: Assiut
country: Egypt
facility: Alazhar university ,Assuit branch ,Egypt
state: Assuit
Study officials:
affiliation: Al-Azhar University
name: Ibrahim Hammad Ibrahim, lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt
name: Khalid s Hassan, Dean of Badr University
role: STUDY_CHAIR
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