Bone DensityNCT06320704
Occlusal Balance Effect on Mandibular Trabecular Bone by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)
A study testing Prepolymerized milled PMMA with light-cured 3D-printed denture teeth. in people with Bone Density, run by Badr University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density
- What is being tested?
- Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2024to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
Show all 9Show fewer
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Bone Density
- Being tested
- Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.
- Keywords
- Denture, Fractal, Density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth. |
| Test | Experimental | 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. Receives: Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular bone changes
Fractal analysis of CBCT in mandibular bone
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start21 Mar 2024
- Primary completion21 Apr 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320704
- Sponsor's protocol ID
- 01067485392
- Status last verified
- Oct 2026
- First submitted
- 19 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06320704
- Acronym / sponsor ID
- 01067485392
- Conditions
- Bone Density
- Keywords
- Denture, Fractal, Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.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. |
| Test | Experimental | Device: Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepolymerized milled PMMA with light-cured 3D-printed denture teeth.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. | Device | Control, Test |
Primary outcome
Trabecular bone changes
Time frame: 24 months
Fractal analysis of CBCT in mandibular bone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepolymerized milled PMMA with light-cured 3D-printed denture teeth. in people with Bone Density, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trabecular bone changes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.