Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution

NCT07400380 | Completed

• 1 other identifier: A09011122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This clinical study aimed to evaluate patient satisfaction and prosthetic complications of different distributions of four implants supported mandibular overdentures using Stress free implant bar (SFI-Bar attachments). Evaluation was done for patient satisfaction and prosthetic complications

Conditions

Patient Satisfaction; Prosthetic Complication

Keywords

implant overdenture; bar attachment; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  A visual analog scale (VAS) and oral health-related quality of life (OHRQoL) were used for evaluating patient satisfaction. Participants in the VAS were instructed to draw a vertical line anywhere along a horizontal line that was used as a scale, with 0 mm representing the worst and 100 mm representing the best. at the point that most accurately reflected their perceptions. General satisfaction, denture stability and retention, occlusion, comfort, ease of cleaning, ease of speaking, ease of chewing, bolus quality, and aesthetics

  one year

Secondary Outcomes (1)

• prosthetic complications

  one year

Study Arms (2)

quadrilateral group

OTHER

4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant.

Procedure: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted

curved group

OTHER

Receive four implants distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants.

Procedure: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted

Interventions

four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted PROCEDURE

Implant positions were planned at canines for both groups. (Intraforaminal): posterior implants are 8 mm posterior to the canine implants \[minimum allowed inter-implant distance for SFIbars (Quadrilateral): posterior implants are 26 mm posterior to the canine implants \[Maximum allowed inter-implant distance for SFI-bars

Also known as: four implants inserted in the mandible and distributed in curved manner and SFI-Bar had been inserted

curved group; quadrilateral group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space.

You may not qualify if:

• Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.
• Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa

Al Mansurah, Egypt

Location

Related Publications (1)

• Mahanna FF, Elsyad MA, Mourad SI, Abozaed HW. Satisfaction and Oral Health-Related Quality of Life of Different Attachments Used for Implant-Retained Overdentures in Subjects with Resorbed Mandibles: A Crossover Trial. Int J Oral Maxillofac Implants. 2020 Mar/Apr;35(2):423-431. doi: 10.11607/jomi.7869.

  PMID: 32142580 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marwa Aboelez, profesor

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: four implants were distributed in interforaminal distance, 2-Implant were inserted in canine region and 2-implant 8mm posterior to canine implants. Group 2: four implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 10, 2026
• Study Start: July 2, 2024
• Primary Completion: February 3, 2025
• Study Completion: October 5, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)