EdentulismNCT07867145
Correlation Between Dynamic Postural Balance and Masticatory Efficiency in Completely Edentulous Patients Rehabilitated With All-on-4 Fixed Prostheses
A study testing All-on-4 Fixed Implant-Supported Prosthesis in people with Edentulism and Postural Balance, run by Reham alaa El sharabasy at 1 site in Egypt.
Trial summary
he goal of this interventional study is to evaluate the relationship between dynamic postural balance and masticatory efficiency in completely edentulous male participants aged 50 to 60 years who are rehabilitated with maxillary and mandibular All-on-4 fixed prostheses. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Edentulism, Postural Balance, Masticatory Performance
- What is being tested?
- All-on-4 Fixed Implant-Supported Prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2025to 28 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age: Between 50 - 60 years.
- Completely edentulous patients with complete removable dentures.
- Sufficient inter-arch height for the restoration (at least 12 mm).
- Proper oral hygiene.
Who cannot join
- - Patients with any medical condition that endanger implant insertion like liver, heart, autoimmune diseases, irradiated arches, or uncontrolled systemic or neurologic diseases.
- Dysfunction related to temporomandibular joint (TMJ) and neuromuscular disorders.
- Smokers.
- History of traumatic jaw injuries.
- Flabby ridges.
- Orthopedic problems.
- Patient unable/unwilling to maintain follow up.
Trial locations and contacts
1 site in 1 country.
About this study
he goal of this interventional study is to evaluate the relationship between dynamic postural balance and masticatory efficiency in completely edentulous male participants aged 50 to 60 years who are rehabilitated with maxillary and mandibular All-on-4 fixed prostheses. The main questions it aims to answer are: Does rehabilitation with All-on-4 fixed prostheses improve masticatory efficiency and dynamic postural body balance over time? Is there a correlation between chewing efficiency and dynamic postural balance after 3 and 6 months of prosthetic loading? Participants will: Receive maxillary and mandibular All-on-4 fixed implant-supported prostheses with a standardized lingualized occlusal scheme. Complete masticatory efficiency assessments using color-changing chewing gum immediately after restoration, at 3 months, and at 6 months post-loading. Perform the Timed Up and Go (TUG) test to evaluate dynamic postural body balance at the same time intervals (immediately, 3 months, and 6 months).
Read the detailed description
he goal of this interventional study is to evaluate the relationship between dynamic postural balance and masticatory efficiency in completely edentulous male participants aged 50 to 60 years who are rehabilitated with maxillary and mandibular All-on-4 fixed prostheses. The main questions it aims to answer are: Does rehabilitation with All-on-4 fixed prostheses improve masticatory efficiency and dynamic postural body balance over time? Is there a correlation between chewing efficiency and dynamic postural balance after 3 and 6 months of prosthetic loading? Participants will: Receive maxillary and mandibular All-on-4 fixed implant-supported prostheses with a standardized lingualized occlusal scheme. Complete masticatory efficiency assessments using color-changing chewing gum immediately after restoration, at 3 months, and at 6 months post-loading. Perform the Timed Up and Go (TUG) test to evaluate dynamic postural body balance at the same time intervals (immediately, 3 months, and 6 months).
- Conditions
- Edentulism, Postural Balance, Masticatory Performance
- Being tested
- All-on-4 Fixed Implant-Supported Prosthesis
- Keywords
- All-on-4, Masticatory efficiency, Dynamic postural 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 ProsthesisOther
Installation of four implants in the edentulous mandible (two vertical anterior implants and two tilted posterior implants) to support a fixed full-arch prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| All-on-4 Rehabilitation Group | Experimental | Completely edentulous patients receiving lower implant-supported fixed prostheses according to the All-on-4 concept. Receives: Other: All-on-4 Fixed Implant-Supported Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory Efficiency
Assessed using color-changing chewing gum (XYLITOL, Lotte Co. Ltd.). After 3 minutes of chewing, the degree of color change was evaluated using a 5-point color scale (1 = green/lowest efficiency, 5 = red/highest efficiency).
Measured: Baseline (immediately after restoration), 3 months, and 6 months post-loading
Dynamic Postural Balance
Evaluated using the Timed Up and Go (TUG) test. The time (in seconds) taken for the participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down was recorded.
Measured: Baseline (immediately after restoration), 3 months, and 6 months post-loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start25 Jul 2025
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
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 EdentulismStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham alaa El sharabasy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham alaa El sharabasy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867145
- Sponsor's protocol ID
- REC-FDBSU-2025-01
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pai P, Dhanya Kumar BH, Nandeeshwar DB. A study on relationship between dynamic postural balance and masticatory efficiency in the elderly population with complete dentures: An in vivo study. J Indian Prosthodont Soc. 2023 Apr-Jun;23(2):170-177. doi: 10.4103/jips.jips_22_23.
PubMed 37102543
Study at a glance
From the registry record, last updated by the sponsor on 9 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
- NCT07867145
- Acronym / sponsor ID
- REC-FDBSU-2025-01
- Conditions
- Edentulism, Postural Balance, Masticatory Performance
- Keywords
- All-on-4, Masticatory efficiency, Dynamic postural balance, Timed Up and Go test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Reham alaa El sharabasyUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 9 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.
he goal of this interventional study is to evaluate the relationship between dynamic postural balance and masticatory efficiency in completely edentulous male participants aged 50 to 60 years who are rehabilitated with maxillary and mandibular All-on-4 fixed prostheses. The main questions it aims to answer are: Does rehabilitation with All-on-4 fixed prostheses improve masticatory efficiency and dynamic postural body balance over time? Is there a correlation between chewing efficiency and dynamic postural balance after 3 and 6 months of prosthetic loading? Participants will: Receive maxillary and mandibular All-on-4 fixed implant-supported prostheses with a standardized lingualized occlusal scheme. Complete masticatory efficiency assessments using color-changing chewing gum immediately after restoration, at 3 months, and at 6 months post-loading. Perform the Timed Up and Go (TUG) test to evaluate dynamic postural body balance at the same time intervals (immediately, 3 months, and 6 months).
Detailed description
he goal of this interventional study is to evaluate the relationship between dynamic postural balance and masticatory efficiency in completely edentulous male participants aged 50 to 60 years who are rehabilitated with maxillary and mandibular All-on-4 fixed prostheses. The main questions it aims to answer are: Does rehabilitation with All-on-4 fixed prostheses improve masticatory efficiency and dynamic postural body balance over time? Is there a correlation between chewing efficiency and dynamic postural balance after 3 and 6 months of prosthetic loading? Participants will: Receive maxillary and mandibular All-on-4 fixed implant-supported prostheses with a standardized lingualized occlusal scheme. Complete masticatory efficiency assessments using color-changing chewing gum immediately after restoration, at 3 months, and at 6 months post-loading. Perform the Timed Up and Go (TUG) test to evaluate dynamic postural body balance at the same time intervals (immediately, 3 months, and 6 months).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All-on-4 Rehabilitation Group | Experimental | Other: All-on-4 Fixed Implant-Supported ProsthesisCompletely edentulous patients receiving lower implant-supported fixed prostheses according to the All-on-4 concept. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: Between 50 - 60 years.
- Completely edentulous patients with complete removable dentures.
- Sufficient inter-arch height for the restoration (at least 12 mm).
- Proper oral hygiene.
Key exclusion criteria (7 listed)
- - Patients with any medical condition that endanger implant insertion like liver, heart, autoimmune diseases, irradiated arches, or uncontrolled systemic or neurologic diseases.
- Dysfunction related to temporomandibular joint (TMJ) and neuromuscular disorders.
- Smokers.
- History of traumatic jaw injuries.
- Flabby ridges.
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 ProsthesisInstallation of four implants in the edentulous mandible (two vertical anterior implants and two tilted posterior implants) to support a fixed full-arch prosthesis. | Other | All-on-4 Rehabilitation Group |
Primary outcome
Masticatory Efficiency
Time frame: Baseline (immediately after restoration), 3 months, and 6 months post-loading
Assessed using color-changing chewing gum (XYLITOL, Lotte Co. Ltd.). After 3 minutes of chewing, the degree of color change was evaluated using a 5-point color scale (1 = green/lowest efficiency, 5 = red/highest efficiency).
Dynamic Postural Balance
Time frame: Baseline (immediately after restoration), 3 months, and 6 months post-loading
Evaluated using the Timed Up and Go (TUG) test. The time (in seconds) taken for the participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down was recorded.
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 9 Oct 2026.
- Background: PubMed 37102543Pai P, Dhanya Kumar BH, Nandeeshwar DB. A study on relationship between dynamic postural balance and masticatory efficiency in the elderly population with complete dentures: An in vivo study. J Indian Prosthodont Soc. 2023 Apr-Jun;23(2):170-177. doi: 10.4103/jips.jips_22_23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prosthesis in people with Edentulism and Postural Balance, run by Reham alaa El sharabasy 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 4 inclusion and 7 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 9 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?
Masticatory Efficiency (time frame: Baseline (immediately after restoration), 3 months, and 6 months post-loading). The study lists 2 primary outcomes in all. 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 NCT07867145, 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 9 Oct 2026.