Patient SatisfactionNCT07400380
Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution
A study testing four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted in people with Patient Satisfaction and Prosthetic Complication, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Prosthetic Complication
- What is being tested?
- four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2024to 5 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Patient Satisfaction, Prosthetic Complication
- Being tested
- four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted
- Keywords
- implant overdenture, bar attachment, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been insertedProcedure or surgery
Also called four implants inserted in the mandible and distributed in curved 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 Jul 2024
- Primary completion3 Feb 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Aboelez, profesor, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400380
- Sponsor's protocol ID
- A09011122
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution for Stress Free Implant Bar Mandibular Overdenture:
- ClinicalTrials.gov ID
- NCT07400380
- Acronym / sponsor ID
- A09011122
- Conditions
- Patient Satisfaction, Prosthetic Complication
- Keywords
- implant overdenture, bar attachment, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| quadrilateral group | Other | Procedure: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant. |
| curved group | Other | Procedure: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been insertedReceive four implants distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been insertedAlso: four implants inserted in the mandible and distributed in curved manner and SFI-Bar had been insertedImplant 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 | Procedure or surgery | curved group, quadrilateral group |
Primary outcome
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
1 secondary outcome
prosthetic complications
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 32142580Mahanna 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.
- Individual participant dataSharing planned: No
Related trials for Patient Satisfaction
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Aboelez, profesor study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted in people with Patient Satisfaction and Prosthetic Complication, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.