Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 9:38 AM
Study NCT ID:
NCT07046104
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture.
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Patient Satisfaction and Oral Health Related Quality of Life for Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture. Crossover Clinical Study.
Status:
COMPLETED
Status Verified Date:
2023-01
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:
ABSTRACT Background: mandibular class 1 modification 1 RPD can be retained by mesially placed implant only, or canines can be used to share in retention using telescopic attachment. So, the aim of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for implant retained Overdenture versus implant-tooth retained Overdenture.
Methods: This clinical cross-over study included 10 partially edentulous patients with only remaining mandibular canines. Every patient received two mandibular implants at the 1st premolar region. Two mandibular implant retained overdenture will be constructed, opposing a maxillary single denture. One of the dentures was made with a design based on implant retention only but the other denture was made with dual implant-tooth retention design. The effects of each overdenture design were evaluated after 3 months. patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100 mm line (Score 0 = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to overdentures such as retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus, and appearance. , and oral health impact profile (OHIP-14) was recorded for both prostheses. The Wilcoxon signed-rank test was done to compare the statistically significant difference between the two groups. SPSS ver.23. P \<.05 was considered significant.
Methods: This clinical cross-over study included 10 partially edentulous patients with only remaining mandibular canines. Every patient received two mandibular implants at the 1st premolar region. Two mandibular implant retained overdenture will be constructed, opposing a maxillary single denture. One of the dentures was made with a design based on implant retention only but the other denture was made with dual implant-tooth retention design. The effects of each overdenture design were evaluated after 3 months. patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100 mm line (Score 0 = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to overdentures such as retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus, and appearance. , and oral health impact profile (OHIP-14) was recorded for both prostheses. The Wilcoxon signed-rank test was done to compare the statistically significant difference between the two groups. SPSS ver.23. P \<.05 was considered significant.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: