- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320704
Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shady Elnaggar
- Phone Number: +201122110085
- Email: shady.mahmoud@buc.edu.eg
Study Locations
-
-
القاهرة
-
Cairo, القاهرة, Egypt
- Recruiting
- Badr University in Cairo
-
Contact:
- Shady Elnaggar
- Email: shady.mahmoud@buc.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Complete Denture Group
Completely edentulous patients undergoing complete denture treatment plan effectively balanced using oculosense device
|
Digital occlusal adjustment of mandibular complete denture using Occulosense digital device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Density
Time Frame: zero
|
Fractal analysis of OPG of mandibular bone
|
zero
|
Bone Density
Time Frame: 1 month
|
Fractal analysis of OPG of mandibular bone
|
1 month
|
Bone Density
Time Frame: 3 months
|
Fractal analysis of OPG of mandibular bone
|
3 months
|
Bone Density
Time Frame: 6 months
|
Fractal analysis of OPG of mandibular bone
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01067485392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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