EdentulismNCT07873983
Dynamic Postural Balance and Masticatory Efficiency in Edentulous Patients With All-on-4 Prostheses
A study testing All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation in people with Edentulism and All-on-4, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Title: Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Edentulous Patients Rehabilitated with All-on-4 Fixed Prostheses Background: Total tooth loss (edentulism) alters sensory feedback from the mouth, which can negatively affect head orientation, body alignment, and overall balance… Read more about this study
- Who is it for?
- Ages 60 to 60 years, men only
- Conditions the study is for
- Edentulism, All-on-4, Masticatory Efficiency
- What is being tested?
- All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2025to 12 Jan 2026
- 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 60 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Completely edentulous patients aged 50-60 years.
- Patients previously rehabilitated with complete removable dentures.
- Sufficient interarch space of at least 12 mm.
- Adequate oral hygiene.
- Willingness and ability to attend follow-up visits.
Who cannot join
- Liver disease, significant cardiac disease, or autoimmune diseases that contraindicate implant placement.
- Previous radiotherapy to the jaws.
- Uncontrolled systemic diseases or neurological disorders.
- Temporomandibular joint dysfunction.
- Neuromuscular disorders.
- Smoking.
Show all 10Show fewer
- History of traumatic jaw injuries.
- Flabby ridges.
- Orthopedic problems affecting balance or mobility.
- Inability or unwillingness to comply with follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Completely Edentulous Patients Rehabilitated With All-on-4 Fixed Prostheses
Title: Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Edentulous Patients Rehabilitated with All-on-4 Fixed Prostheses Background: Total tooth loss (edentulism) alters sensory feedback from the mouth, which can negatively affect head orientation, body alignment, and overall balance, increasing the risk of falls in older adults. While complete dentures replace missing teeth, their lack of stability often limits full recovery of chewing function and balance. Fixed All-on-4 implant restorations provide a rigid, bone-anchored base that restores full functional efficiency and stabilizes the occlusion. Objective: The purpose of this study is to evaluate masticatory (chewing) efficiency in completely edentulous patients treated with maxillary and mandibular All-on-4 fixed implant-supported restorations, and to determine its correlation with dynamic postural body balance over time. Methods: Sixteen completely edentulous male patients aged 50-60 years received maxillary and mandibular All-on-4 fixed restorations with standardized lingualized occlusal schemes. Masticatory efficiency was assessed using a color-changing chewing gum (scored on a 1-5 scale). Dynamic postural body balance was measured using the Timed Up and Go (TUG) test, which records the time in seconds taken to stand from a chair, walk 3 meters, turn, walk back, and sit down. Measurements were recorded at three time points: immediately after final restoration delivery, at 3 months post-loading, and at 6 months post-loading. Expected Outcomes: The study aims to clarify how stabilizing the bite with fixed implant restorations impacts both chewing performance and dynamic walking balance, supporting neuromuscular adaptation and functional independence in edentulous patients.
Read the detailed description
Background and Rationale:
Edentulism and the loss of masticatory function are linked to a significant disruption of oral proprioceptive feedback, impairing the trigeminal-cervical reflex arc. The trigeminal-cervical-vestibular axis regulates the contraction of antigravity muscles throughout the body. Without specialized periodontal mechanoreceptors, total tooth loss obliterates key oral proprioceptive input, frequently leading to altered head posture, impaired spatial orientation, increased postural sway, and an elevated risk of falls, particularly in older adults. While conventional complete dentures replace missing teeth, their mucogingival instability can send erratic sensory signals that confuse central processing centers. Implant-supported fixed restorations (All-on-4) offer a rigid, bone-anchored base that re-establishes stable mechanoreceptive feedback pathways, providing the central nervous system with a reliable structural reference point for spatial coordination. Study Procedures:
Participants in this clinical study undergo the following standard sequence of treatment and evaluation: Pre-Surgical Planning \& Implant Placement:Pre-operative panoramic radiographs and cone-beam computed tomography (CBCT) dual-scans are obtained to construct tissue-supported surgical guides. Four implants (3.7 mm diameter, 11 mm length) are surgically inserted into the mandible and maxilla using a flapless, fully guided technique. The two anterior implants are placed vertically, while the two posterior implants are angled at 30 degrees to avoid critical anatomical structures. Multi-unit abutments are attached, and provisional acrylic restorations are immediately loaded. Prosthetic Rehabilitation:Following osseointegration, final computer-aided design and computer-aided manufacturing (CAD/CAM) fixed prostheses are fabricated and delivered. All restorations are standardized with a lingualized occlusal scheme and a distal cantilever of one tooth per side to maintain uniform biomechanics across all participants. Follow-Up and Assessment Schedule:
Assessments are conducted at three specific intervals: baseline (immediately following final prosthetic delivery), 3 months post-loading, and 6 months post-loading: Masticatory Efficiency Evaluation: Assessed using a standardized color-changing chewing gum (Masticatory Performance Evaluating Gum XYLITOL). Participants chew the gum freely for 3 minutes. Chewed specimens are flattened to a uniform 1 mm thickness and evaluated on a validated 5-point color scale (1 = green/lowest efficiency; 5 = red/highest efficiency). Dynamic Postural Balance Evaluation: Measured using the Timed Up and Go (TUG) test. Participants start seated in a standardized chair, stand up upon command, walk 3 meters at their regular pace, turn around, return to the chair, and sit down. Test conditions (footwear, walkway, time of day) are strictly standardized across visits. Time taken is recorded in seconds across three trials and averaged
- Conditions
- Edentulism, All-on-4, Masticatory Efficiency, Dynamic Postural Balance
- Being tested
- All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation
- Keywords
- completely edentulous patients, All-on four implant prosthesis, Masticatory efficiency, dynamic balance, timed up and go test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-on-4 Fixed Implant-Supported Prosthetic RehabilitationDevice
Rehabilitation of completely edentulous patients with maxillary and mandibular fixed implant-supported prostheses using the All-on-4 concept. Each arch was restored using four dental implants, with two anterior implants placed axially and two posterior implants placed at an approximately 30° angulation. The definitive prostheses were designed digitally and fabricated with lingualized occlusion and a distal cantilever on each side.
| Study group | Role | What they receive |
|---|---|---|
| All-on-4 Fixed Prostheses | Experimental | Participants received maxillary and mandibular All-on-4 fixed prostheses. The prostheses were fabricated using a digital workflow and designed with lingualized occlusion. Masticatory efficiency and dynamic postural balance were assessed after prosthetic rehabilitation and at 3 and 6 months of follow-up. Receives: Device: All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Masticatory Efficiency and Dynamic Postural Balance(Spearman's rank correlation coefficient (rho))
The correlation between masticatory efficiency and dynamic postural balance was assessed using Spearman's rank correlation coefficient. Masticatory efficiency was measured using color-changing chewing gum scored on a 5-point scale, and dynamic postural balance was measured using the Timed Up and Go (TUG) test, recorded in seconds. The correlation coefficient was calculated at 3 and 6 months after prosthetic rehabilitation.
Measured: 3 and 6 months after prosthetic rehabilitation.
Secondary outcomes (2)
Dynamic postural balance(Timed up and go test)
Dynamic postural balance was assessed using the Timed Up and Go (TUG) test. The time required to complete the test was recorded in seconds. Measurements were obtained immediately after prosthetic rehabilitation and at 3 and 6 months after rehabilitation.
Measured: Immediately after prosthetic rehabilitation, and at 3 and 6 months after rehabilitation.
Masticatory Efficiency( Score on a 5-point scale)
Masticatory efficiency was evaluated using color-changing chewing gum (Masticatory Performance Evaluating Gum, Lotte Co. Ltd., Japan). Performance was assessed using a 5-point color scale ranging from 1 (green) to 5 (red), according to the manufacturer's assessment scale.
Measured: Immediately after prosthetic rehabilitation, and at 3 and 6 months after rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start25 Jul 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Not applicable
- Intervention model
- Single group
- Model description
- All 16 participants in the study received the same intervention (maxillary and mandibular All-on-4 fixed prostheses) and were followed prospectively over time.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham A. El Sharabasy, Beni-Suef University
- Investigators
- Reham El sharabasy, Principal investigator, Faculty of Dentistry, Beni-Suef University, Beni Suef, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873983
- Sponsor's protocol ID
- REC-FDBSU-10042025-01-SR
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Completely Edentulous Patients Rehabilitated With All-on-4 Fixed Prostheses
- ClinicalTrials.gov ID
- NCT07873983
- Acronym / sponsor ID
- REC-FDBSU-10042025-01-SR
- Conditions
- Edentulism, All-on-4, Masticatory Efficiency, Dynamic Postural Balance
- Keywords
- completely edentulous patients, All-on four implant prosthesis, Masticatory efficiency, dynamic balance, timed up and go test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 14 Oct 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.
Title: Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Edentulous Patients Rehabilitated with All-on-4 Fixed Prostheses Background: Total tooth loss (edentulism) alters sensory feedback from the mouth, which can negatively affect head orientation, body alignment, and overall balance, increasing the risk of falls in older adults. While complete dentures replace missing teeth, their lack of stability often limits full recovery of chewing function and balance. Fixed All-on-4 implant restorations provide a rigid, bone-anchored base that restores full functional efficiency and stabilizes the occlusion. Objective: The purpose of this study is to evaluate masticatory (chewing) efficiency in completely edentulous patients treated with maxillary and mandibular All-on-4 fixed implant-supported restorations, and to determine its correlation with dynamic postural body balance over time. Methods: Sixteen completely edentulous male patients aged 50-60 years received maxillary and mandibular All-on-4 fixed restorations with standardized lingualized occlusal schemes. Masticatory efficiency was assessed using a color-changing chewing gum (scored on a 1-5 scale). Dynamic postural body balance was measured using the Timed Up and Go (TUG) test, which records the time in seconds taken to stand from a chair, walk 3 meters, turn, walk back, and sit down. Measurements were recorded at three time points: immediately after final restoration delivery, at 3 months post-loading, and at 6 months post-loading. Expected Outcomes: The study aims to clarify how stabilizing the bite with fixed implant restorations impacts both chewing performance and dynamic walking balance, supporting neuromuscular adaptation and functional independence in edentulous patients.
Detailed description
Background and Rationale:
Edentulism and the loss of masticatory function are linked to a significant disruption of oral proprioceptive feedback, impairing the trigeminal-cervical reflex arc. The trigeminal-cervical-vestibular axis regulates the contraction of antigravity muscles throughout the body. Without specialized periodontal mechanoreceptors, total tooth loss obliterates key oral proprioceptive input, frequently leading to altered head posture, impaired spatial orientation, increased postural sway, and an elevated risk of falls, particularly in older adults. While conventional complete dentures replace missing teeth, their mucogingival instability can send erratic sensory signals that confuse central processing centers. Implant-supported fixed restorations (All-on-4) offer a rigid, bone-anchored base that re-establishes stable mechanoreceptive feedback pathways, providing the central nervous system with a reliable structural reference point for spatial coordination. Study Procedures:
Participants in this clinical study undergo the following standard sequence of treatment and evaluation: Pre-Surgical Planning \& Implant Placement:Pre-operative panoramic radiographs and cone-beam computed tomography (CBCT) dual-scans are obtained to construct tissue-supported surgical guides. Four implants (3.7 mm diameter, 11 mm length) are surgically inserted into the mandible and maxilla using a flapless, fully guided technique. The two anterior implants are placed vertically, while the two posterior implants are angled at 30 degrees to avoid critical anatomical structures. Multi-unit abutments are attached, and provisional acrylic restorations are immediately loaded. Prosthetic Rehabilitation:Following osseointegration, final computer-aided design and computer-aided manufacturing (CAD/CAM) fixed prostheses are fabricated and delivered. All restorations are standardized with a lingualized occlusal scheme and a distal cantilever of one tooth per side to maintain uniform biomechanics across all participants. Follow-Up and Assessment Schedule:
Assessments are conducted at three specific intervals: baseline (immediately following final prosthetic delivery), 3 months post-loading, and 6 months post-loading: Masticatory Efficiency Evaluation: Assessed using a standardized color-changing chewing gum (Masticatory Performance Evaluating Gum XYLITOL). Participants chew the gum freely for 3 minutes. Chewed specimens are flattened to a uniform 1 mm thickness and evaluated on a validated 5-point color scale (1 = green/lowest efficiency; 5 = red/highest efficiency). Dynamic Postural Balance Evaluation: Measured using the Timed Up and Go (TUG) test. Participants start seated in a standardized chair, stand up upon command, walk 3 meters at their regular pace, turn around, return to the chair, and sit down. Test conditions (footwear, walkway, time of day) are strictly standardized across visits. Time taken is recorded in seconds across three trials and averaged
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All 16 participants in the study received the same intervention (maxillary and mandibular All-on-4 fixed prostheses) and were followed prospectively over time.
| Arm | Type | Receives |
|---|---|---|
| All-on-4 Fixed Prostheses | Experimental | Device: All-on-4 Fixed Implant-Supported Prosthetic RehabilitationParticipants received maxillary and mandibular All-on-4 fixed prostheses. The prostheses were fabricated using a digital workflow and designed with lingualized occlusion. Masticatory efficiency and dynamic postural balance were assessed after prosthetic rehabilitation and at 3 and 6 months of follow-up. |
Who may qualify
- Ages
- 60 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Completely edentulous patients aged 50-60 years.
- Patients previously rehabilitated with complete removable dentures.
- Sufficient interarch space of at least 12 mm.
- Adequate oral hygiene.
- Willingness and ability to attend follow-up visits.
Key exclusion criteria (10 listed)
- Liver disease, significant cardiac disease, or autoimmune diseases that contraindicate implant placement.
- Previous radiotherapy to the jaws.
- Uncontrolled systemic diseases or neurological disorders.
- Temporomandibular joint dysfunction.
- Neuromuscular disorders.
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 |
|---|---|---|
| All-on-4 Fixed Implant-Supported Prosthetic RehabilitationRehabilitation of completely edentulous patients with maxillary and mandibular fixed implant-supported prostheses using the All-on-4 concept. Each arch was restored using four dental implants, with two anterior implants placed axially and two posterior implants placed at an approximately 30° angulation. The definitive prostheses were designed digitally and fabricated with lingualized occlusion and a distal cantilever on each side. | Device | All-on-4 Fixed Prostheses |
Primary outcome
Correlation Between Masticatory Efficiency and Dynamic Postural Balance(Spearman's rank correlation coefficient (rho))
Time frame: 3 and 6 months after prosthetic rehabilitation.
The correlation between masticatory efficiency and dynamic postural balance was assessed using Spearman's rank correlation coefficient. Masticatory efficiency was measured using color-changing chewing gum scored on a 5-point scale, and dynamic postural balance was measured using the Timed Up and Go (TUG) test, recorded in seconds. The correlation coefficient was calculated at 3 and 6 months after prosthetic rehabilitation.
2 secondary outcomes
Dynamic postural balance(Timed up and go test)
Time frame: Immediately after prosthetic rehabilitation, and at 3 and 6 months after rehabilitation.
Masticatory Efficiency( Score on a 5-point scale)
Time frame: Immediately after prosthetic rehabilitation, and at 3 and 6 months after rehabilitation.
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Reham El sharabasy principal investigator
Faculty of Dentistry, Beni-Suef University, Beni Suef, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation in people with Edentulism and All-on-4, run by Beni-Suef 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 5 inclusion and 10 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 14 Oct 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?
Correlation Between Masticatory Efficiency and Dynamic Postural Balance(Spearman's rank correlation coefficient (rho)) (time frame: 3 and 6 months after prosthetic rehabilitation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.