Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture.

NCT07046104 | Completed

• 1 other identifier: A0103024RP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health Impact Profile Short Version 14 (OHIP 14)

Outcome Measures

Primary Outcomes (1)

• patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)

  3 months

Secondary Outcomes (1)

• oral health impact profile (OHIP-14) was recorded for both prostheses.

  3 months

Study Arms (2)

implant retained group

ACTIVE COMPARATOR

two implants in molar position and two remaining canines

Other: implant retained overdenture prosthesis

implant tooth retained group

ACTIVE COMPARATOR

implant in molar position and two remaining canines

Other: implant canine retained overdenture prosthesis

Interventions

implant retained overdenture prosthesis OTHER

implant retained only prosthesis

implant retained group

implant canine retained overdenture prosthesis OTHER

prosthesis retention from implant and canine

implant tooth retained group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• This research will be done on patients who were previously received 2 mesially placed implants in the 1st premolar region with only two remaining mandibular canines with opposing maxillary single denture

You may not qualify if:

• uncontrolled diabetic patients

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Basmsa

Al Mansurah, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: July 1, 2025
• Study Start: January 12, 2023
• Primary Completion: July 7, 2024
• Study Completion: August 7, 2024
• Last Updated: July 1, 2025

Record last verified: 2023-01

Locations

EG (1)