NCT07867145

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

EdentulismPostural BalanceMasticatory Performance

Keywords

All-on-4, Masticatory efficiency, Dynamic postural balance, Timed Up and Go test

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Baseline (immediately after restoration), 3 months, and 6 months post-loading

Study Arms (1)

All-on-4 Rehabilitation Group

EXPERIMENTAL

Completely edentulous patients receiving lower implant-supported fixed prostheses according to the All-on-4 concept.

Other: All-on-4 Fixed Implant-Supported Prosthesis

Interventions

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.

All-on-4 Rehabilitation Group

Eligibility Criteria

Age50 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Beni Suef

Cairo, Giza Governorate, 12311, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 37102543BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

July 25, 2025

Primary Completion

January 28, 2026

Study Completion

January 28, 2026

Last Updated

October 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)