CClinicalTrials.gg
CompletedNCT07400380Updated Feb 13, 2026

Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution

An interventional study of four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted in Patient Satisfaction and Prosthetic Complication, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jul 2024, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study 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

Read the detailed description

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). Materials and Methods: thirty completely edentulous patients with insufficient retention and stability of their conventional mandibular denture were eligible for this study. All patients received new maxillary and mandibular dentures. The patients were randomly divided into three groups. (G1): four implants were distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants. (G2): 4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant. Patient satisfaction was evaluated by visual analogue scale and prosthetic complications were evaluated on the patient level and implant patients.

02

Conditions studied

  • Patient Satisfaction
  • Prosthetic Complication

Browse trials for

Keywords

  • implant overdenture
  • bar attachment
  • patient satisfaction
03

In context

Patient Satisfaction

256 studies on the registry are indexed under Patient Satisfaction; 127 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 196 interventional studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 182 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Other
    quadrilateral group

    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

  • Other
    curved group

    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

  • Procedurefour implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted

    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

06

What researchers measure

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

    Time frame: one year

Secondary outcomes

  1. prosthetic complications

    The complications include (1) complications of attachments: abutment fracture, abutment screw loosening, screw fracture, wear/distortion of retentive components, activation of retentive components, retention loss and replacement of retentive components, and separation of retentive components from the denture base, (2) technical complications of mandibular over-dentures: reline, fracture/remake, teeth wear, teeth separation/fracture, (3) technical complications of maxillary dentures: reline, fracture/remake, teeth wear, teeth separation/fracture, (4) Soft tis-sue complications of mandibular overdentures and maxillary dentures: mucositis, soreness, ulcer decubitus, hyperplasia, and flabbyridge

    Time frame: one year

07

Study locations

1 site
  • Marwa
    Al Mansurah, Egypt
08

References and documents

Publications

  • 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. PubMed 32142580 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07400380
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Feb 10, 2026
Start date
Jul 2, 2024
Primary completion
Feb 3, 2025
Completion
Oct 5, 2025
Last update
Feb 13, 2026

Study contacts

Marwa Aboelez, profesor
study chair · Mansoura University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion