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

Bone Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320704
• Other study ID #: 01067485392
• Status: Recruiting
• Start date: March 21, 2024
• Est. completion date: September 21, 2024

Study information

• Verified date: March 2024
• Source: Badr University
• Contact: Shady Elnaggar
• Phone: +201122110085
• Email: shady.mahmoud[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Density

Intervention

Device:
• Digital occlusal adjustment using Occulosense digital device
Digital occlusal adjustment of mandibular complete denture using Occulosense digital device

Locations

Country	Name	City	State
Egypt	Badr University in Cairo	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Density	Fractal analysis of OPG of mandibular bone	zero
Primary	Bone Density	Fractal analysis of OPG of mandibular bone	1 month
Primary	Bone Density	Fractal analysis of OPG of mandibular bone	3 months
Primary	Bone Density	Fractal analysis of OPG of mandibular bone	6 months