AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Egypt1 site
  • Badr University in Cairo

    Cairo, Cairo Governorate

Other trials in Egypt

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 groups in NCT06320704
Study groupRoleWhat they receive
ControlActive comparatorThis 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.
TestExperimentalThis 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.

  1. 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.

  1. First posted20 Mar 2024
  2. Study start21 Mar 2024
  3. Primary completion21 Apr 2026
  4. Study completion21 May 2026

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in