Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:32 AM
Study NCT ID:
NCT07433868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach
Sponsor:
International Dental Contiuing Education
Organization:
Study Overview
Official Title:
Evaluation of Implant Stability Following Maxillary Sinus Floor Elevation Through Piezoelectric Trans-crestal Approach Versus Crestal Implant Approach: A 1-year Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rehabilitation of the maxillary posterior region is a challenge in every-day clinical practice. Following extraction of maxillary molars, alveolar ridge atrophy along with maxillary sinus pneumatization decrease the bone volume and increase implant placement complexity (Lyu et al., 2023). Several surgical procedures have been proposed to overcome these complications, including; short implants (Bechara et al., 2017), tilted implants (Meng and Zhang, 2022) as well as different sinus floor elevation techniques (Irinakis, 2011, Bishbish et al., 2023, Dragonas et al., 2023). Crestal maxillary sinus floor elevation has been considered a predictable and less invasive approach, providing sufficient vertical ridge height with high rates of implant survival (Guruprasad et al., 2024). However, there's limited body of evidence comparing the efficacy of different trans-crestal approaches as PISE and crestal implant approach with no bone graft. Thus, further clinical trials are recommended to determine whether the adjunctive use of piezoelectric instrumentation in internal sinus elevation offers significant clinical advantages over the crestal implant approach.
Detailed Description:
Aim of the study: The aim of this study is to evaluate clinical long term implant stability and radiographic vertical bone height gain after implant placement in posterior maxilla using crestal implant approach in comparison to PISE.
Hypothesis:
Research Null hypothesis: There will be no difference between implants placed with crestal implant approach and PISE, regarding long term implant stability and radiographic bone height gain.
The primary objective:
• To compare the implant stability quotient (ISQ) between the two treatment modalities, will be assessed by resonance frequency analysis using "Osstell" (Integration Diagnostics, Save Dalen, Sweden)
The secondary objectives:
* To assess intra-sinus vertical bone gain around dental implants, in mm, will be assessed by CBCT.
* To assess marginal bone level, in mm
* To assess peri-implant soft tissue parameters by modified plaque and bleeding indices.
* To evaluate post-operative pain.
* To assess any surgical or post-surgical complications.
Hypothesis:
Research Null hypothesis: There will be no difference between implants placed with crestal implant approach and PISE, regarding long term implant stability and radiographic bone height gain.
The primary objective:
• To compare the implant stability quotient (ISQ) between the two treatment modalities, will be assessed by resonance frequency analysis using "Osstell" (Integration Diagnostics, Save Dalen, Sweden)
The secondary objectives:
* To assess intra-sinus vertical bone gain around dental implants, in mm, will be assessed by CBCT.
* To assess marginal bone level, in mm
* To assess peri-implant soft tissue parameters by modified plaque and bleeding indices.
* To evaluate post-operative pain.
* To assess any surgical or post-surgical complications.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: