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Completed

NCT Number: NCT06320704

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

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.

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Key information

Conditions

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Badr University in Cairo

Cairo, Cairo Governorate, Egypt

About this study

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.

There have been various occlusion schemes proposed. The term "lingual occlusion," or "LO," was first used in 1941 to describe the occlusion of the mandibular occlusal surfaces with the maxillary lingual cusps in a central and non-centric relationship. This makes it simpler to acquire both the dental position and the occlusal scheme LO.

DeVan suggested the neutral-centric or zero-degree (ZD) occlusion method, in which the cusps are at a zero-degree inclination to balance the incline, centralise the masticatory power, and get around the challenge of attaining precise jaw relations. Moreover, compared to cusped teeth, teeth with a zero-degree occlusal angle exert less pressure on the soft tissues. 13,14 The optimal occlusal scheme in terms of masticatory performance and patient quality of life/satisfaction, however, has not been determined.

Many radiomorphometric studies have employed digital panoramic radiographs to predict osteoporosis based on BMD levels. Dental professionals may employ the mandibular cortical width (MCW), panoramic mandibular index, and Klemetti index as general useful methods to screen for low BMD and anticipate osteoporosis. The meta-analysis determined that the erosion of mandibular cortical bone had an estimated sensitivity and specificity in identifying osteoporosis of 0.806 and 0.643, respectively.

Because individuals with cortical width more than 4 mm typically have normal BMD, MCW also exhibits improved specificity in eliminating osteopenia/osteoporosis. It will be extremely helpful for the initial screening of the osteoporosis risk and advising the assessment of further clinical risk factors to prevent osteoporotic fracture because the panoramic radiograph is frequently employed as a diagnostic tool in dental practice.

Nevertheless, it takes a lot of effort and is prone to measurement errors to manually measure the potential values in a panoramic radiograph. By evaluating the breadth of cortical bone at the mandible, automated osteoporosis detection utilizing digital panoramic radiography is typically carried out to aid doctors. According to a digital panoramic radiograph used in a computer-assisted technique for detecting osteoporosis, there is an about 53% association between cortical bone width and the results of the BMD assessment. In agreement with this, the study by Geary et al. also showed a significant correlation between the width of cortical bone and bone density, though the significance level decreased when other variables, like age, the length and width of the jaw, and the number of teeth, were added to determine bone density.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Trabecular bone changes

    Time frame: 48 months

    Fractal analysis of CBCT in mandibular bone

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

Fractal Analysis of Mandibular Trabecular Bone Changes in Complete Denture Patients Restored With Pre-polymerized Milled PMMA Compared With Light-cured 3D-printed Teeth: a Split-mouth Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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