Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)
1 other identifier
observational
16
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2024
CompletedMarch 20, 2024
March 1, 2024
6 months
May 19, 2023
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Bone Density
Fractal analysis of OPG of mandibular bone
zero
Bone Density
Fractal analysis of OPG of mandibular bone
1 month
Bone Density
Fractal analysis of OPG of mandibular bone
3 months
Bone Density
Fractal analysis of OPG of mandibular bone
6 months
Study Arms (1)
Complete Denture Group
Completely edentulous patients undergoing complete denture treatment plan effectively balanced using oculosense device
Interventions
Digital occlusal adjustment of mandibular complete denture using Occulosense digital device
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Badr Universitylead
Study Sites (1)
Badr University in Cairo
Cairo, Cairo Governorate, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- 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
September 21, 2024
Study Completion
September 21, 2024
Last Updated
March 20, 2024
Record last verified: 2024-03