An interventional study of All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation in Edentulism, All-on-4 and Masticatory Efficiency, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to male participants aged 60 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
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
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Exclusion Criteria:
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.
Device: All-on-4 Fixed Implant-Supported Prosthetic Rehabilitation
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.
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.
Time frame: 3 and 6 months after prosthetic rehabilitation.
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.
Time frame: 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.
Time frame: Immediately after prosthetic rehabilitation, and at 3 and 6 months after rehabilitation.
Plan to share: No
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