Occlusal Balance Effect on Mandibular Trabecular Bone by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)

NCT06320704 | Completed

• 1 other identifier: 01067485392
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Although the number of individuals who are edentulous is declining, a sizable fraction still needs a complete denture for their oral rehabilitation.Tooth loss is an issue in public health that determines quality of life since it is linked to socioeconomic, physiological, and psychological aspects. In patients who are completely edentulous, dental implants have been viewed as a favorable choice for rehabilitation.

Conditions

Bone Density

Keywords

Denture, Fractal, Density

Outcome Measures

Primary Outcomes (1)

• Trabecular bone changes

  Fractal analysis of CBCT in mandibular bone

  48 months

Study Arms (2)

Control

This study included complete denture wearers undergoing mandibular rehabilitation in a split-mouth randomized clinical trial. The two prosthetic conditions were applied intra-individually on opposite sides, allowing direct comparison of the effect of prepolymerized milled PMMA denture teeth on mandibular trabecular bone architecture as assessed by fractal analysis.

Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.

Test

This study included complete denture wearers undergoing mandibular rehabilitation in a split-mouth randomized clinical trial. The two prosthetic conditions were applied intra-individually on opposite sides, allowing direct comparison of the effect of light-cured 3D-printed denture teeth on mandibular trabecular bone architecture as assessed by fractal analysis.

Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.

Interventions

Prepolymerized milled PMMA with light-cured 3D-printed denture teeth. DEVICE

Complete denture prosthetic rehabilitation using two digitally fabricated approaches in a split-mouth randomized design. One side of the prosthesis was fabricated with prepolymerized milled PMMA, and the contralateral side used light-cured 3D-printed denture teeth. The intervention was performed to compare the effect of the two prosthetic materials/techniques on mandibular trabecular bone changes assessed by fractal analysis.

Control; Test

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients present with severe systemic diseases as uncontrolled diabetes, bleeding disorders, neuromuscular disorders, psychiatric disorders and patients on chemotherapy or radiotherapy will be excluded as they will require special management in their drug doses, short appointment visits which will has to be early morning. Furthermore they are more liable to drop out during the follow-up period of the trial.

You may qualify if:

• Completely edentulous patients ranging from age 45 to 75 years
• Angle's Class I skeletal relationship
• Normal facial symmetry
• Cooperative patients
• Adequate inter-arch space not less than 12mm

You may not qualify if:

• Temporomandibular disorders
• Uncontrolled diabetes
• Bleeding disorders or anticoagulant therapy
• Flabby tissues or sharp mandibular residual ridge.
• Heavy smokers.
• Patient's with neuromuscular disorders
• Patients on chemotherapy or radiotherapy
• Severe psychiatric disorders
• Angle's class II and III skeletal relationship

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Badr University in Cairo

Cairo, Cairo Governorate, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: March 20, 2024
• Study Start: March 21, 2024
• Primary Completion: April 21, 2026
• Study Completion: May 21, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

EG (1)