Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760457
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2021-01-27
Brief Title:
Mandibular Overdentures Retained by Mini Implants a Clinical Trial Comparing Different Surgical and Loading Protocols
Sponsor:
Universidade Federal de Goias
Organization:
Universidade Federal de Goias
Study Overview
Official Title:
One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures a Factorial Randomized Clinical Trial Testing the Outcomes of ImmediateDelayed Loading and FlappedFlapless Surgery
Status:
COMPLETED
Status Verified Date:
2023-05
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:
SMIS
Brief Summary:
This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures PROMs following the use of four mini implants for mandibular overdenture retention
The main study hypotheses are
1 There are significant improvements in PROMs following implant intervention compared to baseline measures
2 Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol
3 Flapless surgery has similar post-insertion outcomes compared to flapped surgery
The main study hypotheses are
1 There are significant improvements in PROMs following implant intervention compared to baseline measures
2 Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol
3 Flapless surgery has similar post-insertion outcomes compared to flapped surgery
Detailed Description:
This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures PROMs following the use of four mini implants for mandibular overdenture retention
Main study hypotheses
1 There are significant improvements in PROMs following implant intervention compared to baseline measures
2 Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol
3 Flapless surgery has similar post-insertion outcomes compared to flapped surgery
Statement of clinical relevance
Mini implants are an alternative to standard implants for overdentures They are suitable for insertion in narrow ridges are less invasive simpler less costly and faster to perform and are especially advantageous for older and frail patients who would benefit from more conservative and less burdensome treatments Although previous studies reported favorable outcomes regarding patient oral comfort and function there is a need for implantattachment systems with higher predictability on implant survival and retention performance in the long-term This study aims to provide clinical evidence on the newly developed 24mm one-piece TiZr mini implant with a miniaturized carbon-based coating attachment
Methods
This is a randomized clinical trial using a factorial design to test the effectiveness of a mandibular overdenture retained by four mini implants Participants will be randomized using a 22 factorial design immediatedelayed loading factor 1 and flaplessflapped surgery factor 2 New conventional complete dentures will be provided as the baseline treatment Next eligible participants will be those who completed a 6-month period of denture usage and are in need of implants to improve the function of the mandibular denture Imaging exam should present a minimum of 54 mm of ridge width in the interforaminal region recommended for flapless surgery
Included subjects to take part in the RCT will be randomized to the treatment groups according to the combined study factors - loading protocols immediate IL or delayed DL and surgical approaches flapless FLS or flapped FPS surgery Hence the combined factors will results in four groups
ILFLS Group I
ILFPS Group II
DLFLS Group III
DLFPS Group IV Considering the patients perspective this study design assumed a worst protocol delayed and flapped - Group IV and a best protocol flapless and immediate - Group I and two other intermediary conditions flappedimmediate and flaplessdelayed
All participants will receive four Straumann Mini Implant System one-piece Tissue Level implants with an Optiloc prosthetic connection and PEEK matrix inserts Surgery will follow the workflow for the surgical procedure for the Straumann Mini Implant System concerning preoperative planning implant bed preparation and implant insertion For the prosthetic procedures we will perform a chairside incorporation of the retentive inserts to convert the existing well-fitting and well-functioning lower denture into an overdenture with the Optiloc Retentive SystemStraumann Mini Implants
Outcomes will include short-term outcomes Patient perceived burdens in surgery postoperative swelling and pain consumption of analgesics and surgical time and long-term - 1-year implant survival and success peri-implant marginal bone level changes PROMs retention force prosthodontic events outcomes Sample size calculation resulted in a total of 74 participants 18 in each of the four groups Data analysis will include descriptive and bivariate analyses Kaplan-Meier curves and regression models using Generalized Estimating Equations GEE for longitudinal data
Main study hypotheses
1 There are significant improvements in PROMs following implant intervention compared to baseline measures
2 Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol
3 Flapless surgery has similar post-insertion outcomes compared to flapped surgery
Statement of clinical relevance
Mini implants are an alternative to standard implants for overdentures They are suitable for insertion in narrow ridges are less invasive simpler less costly and faster to perform and are especially advantageous for older and frail patients who would benefit from more conservative and less burdensome treatments Although previous studies reported favorable outcomes regarding patient oral comfort and function there is a need for implantattachment systems with higher predictability on implant survival and retention performance in the long-term This study aims to provide clinical evidence on the newly developed 24mm one-piece TiZr mini implant with a miniaturized carbon-based coating attachment
Methods
This is a randomized clinical trial using a factorial design to test the effectiveness of a mandibular overdenture retained by four mini implants Participants will be randomized using a 22 factorial design immediatedelayed loading factor 1 and flaplessflapped surgery factor 2 New conventional complete dentures will be provided as the baseline treatment Next eligible participants will be those who completed a 6-month period of denture usage and are in need of implants to improve the function of the mandibular denture Imaging exam should present a minimum of 54 mm of ridge width in the interforaminal region recommended for flapless surgery
Included subjects to take part in the RCT will be randomized to the treatment groups according to the combined study factors - loading protocols immediate IL or delayed DL and surgical approaches flapless FLS or flapped FPS surgery Hence the combined factors will results in four groups
ILFLS Group I
ILFPS Group II
DLFLS Group III
DLFPS Group IV Considering the patients perspective this study design assumed a worst protocol delayed and flapped - Group IV and a best protocol flapless and immediate - Group I and two other intermediary conditions flappedimmediate and flaplessdelayed
All participants will receive four Straumann Mini Implant System one-piece Tissue Level implants with an Optiloc prosthetic connection and PEEK matrix inserts Surgery will follow the workflow for the surgical procedure for the Straumann Mini Implant System concerning preoperative planning implant bed preparation and implant insertion For the prosthetic procedures we will perform a chairside incorporation of the retentive inserts to convert the existing well-fitting and well-functioning lower denture into an overdenture with the Optiloc Retentive SystemStraumann Mini Implants
Outcomes will include short-term outcomes Patient perceived burdens in surgery postoperative swelling and pain consumption of analgesics and surgical time and long-term - 1-year implant survival and success peri-implant marginal bone level changes PROMs retention force prosthodontic events outcomes Sample size calculation resulted in a total of 74 participants 18 in each of the four groups Data analysis will include descriptive and bivariate analyses Kaplan-Meier curves and regression models using Generalized Estimating Equations GEE for longitudinal data
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?:
None