Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution

February 10, 2026 updated by: Mansoura University

Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution for Stress Free Implant Bar Mandibular Overdenture:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Marwa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • four implants inserted in the mandible and distributed in curved 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
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
Other Names:
  • four implants inserted in the mandible and distributed in curved manner and SFI-Bar had been inserted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
prosthetic complications
Time Frame: one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Marwa Aboelez, profesor, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Actual)

February 3, 2025

Study Completion (Actual)

October 5, 2025

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A09011122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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