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DenturesNCT06856239

Comparison of Flexural Strength and Flexural Modulus of Conventional and Graphene-Reinforced Polymethyl Methacrylate

A study testing Graphene in people with Dentures and Denture,Complete, run by Altamash Institute of Dental Medicine at 2 sites in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Study Title: Comparison of Flexural Strength and Modulus of Conventional and Graphene-Reinforced PMMA Introduction: This in-vitro experimental study aims to compare the flexural strength and flexural modulus of conventional polymethyl methacrylate (PMMA) and graphene-reinforced PMMA (G-PMMA) used in denture bases. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dentures, Denture,Complete
What is being tested?
Graphene
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesPakistan
Study dates
24 Feb 2025to 25 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Samples that are dimensionally accurate in accordance to ISO Standard 178.21
  • Sample that are free from surface porosities like gaseous, granular or contraction porosities.
  • Samples have uniform color and surface texture indicating proper curing.
  • Samples free from crazing defects and warpage.
  • Samples with no signs of distortion after thermocycling.
  • Samples with homogeneously distributed graphene by visual inspection of samples.

Who cannot join

  • • Samples with incorrect mixing ratio of base to catalyst.
  • Samples in which the metal bar is partially exposed.
  • Samples that are not fully embedded in plaster.
  • Samples showing sign of contamination from foreign body during packing process.
  • Samples with improper mixing of plaster shows a sign of cracks and voids surrounding the samples.
  • Samples in which the flask will not properly sealed during flasking.
  • Samples fractured due to thermocycling.
  • Samples fractured during handling or transportation before testing.

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Altamash institute of dental medicine

    Karachi, Sindh

  • Altamash institute of dental medicine

    Karachi

Other trials in Pakistan

About this study

Study Title: Comparison of Flexural Strength and Modulus of Conventional and Graphene-Reinforced PMMA

Introduction:

Read more

This in-vitro experimental study aims to compare the flexural strength and flexural modulus of conventional polymethyl methacrylate (PMMA) and graphene-reinforced PMMA (G-PMMA) used in denture bases. PMMA is widely used for dentures due to its affordability, aesthetics, and biocompatibility but has limitations such as low flexural strength and susceptibility to fracture. Graphene, a strong and flexible nanomaterial, has demonstrated potential in enhancing PMMA's mechanical properties.

OBJECTIVE:

To compare the flexural strength and flexural modulus of conventional and graphene reinforced polymethyl methacrylate

HYPOTHESIS:

Null Hypothesis:

There is no difference in flexural strength and flexural modulus of graphene reinforced PMMA and conventional PMMA.

Alternative Hypothesis:

There is a difference in flexural strength and flexural modulus of graphene-reinforced PMMA and conventional PMMA.

Methodology:

  • Study Design: In-vitro experimental trial
  • Study SETTING:
  • The study will be carried out at Altamash Institute of Dental Medicine in the department of prosthodontic, Karachi Pakistan.
  • The graphene (Miraculum Graphene Private Limited,Gujrat, Ahmedabad,India) will be reduced at Karachi University's Food Science Department.
  • For the formation of mold, the digital metal bar (CoCr, Eplus3D, Hangzhou China) will be fabricated by Selective laser melting (SLM) (Audental Shanghai, East-central China) at Chughtai Lab in Peshawar, Pakistan.
  • The acrylic (Mr. Teeth, Royale Elite, Surrey,United Kingdom) samples will be cured by short curing cycling in the prosthodontic department at Bahria dental University, Karachi.
  • The thermocycling (thermocycler, San Francisco, USA) and universal testing for flexural strength and modulus of acrylic samples will be performed at the research laboratory of Dow University of health sciences.
  • Sample Size: The projected sample size for this study is 76 specimen, 38 samples per group by comparing two means in open epi software19 (version 3).The calculation was based on the result of Kaan Yerliyurt 11 study, considering the mean value of 68.16 MPa and standard deviation (SD) of 5.79 MPa for the experimental group and the mean value of 72.6 MPa and standard deviation (SD) of 7.84 MPa for the control group of flexural strength. The analysis accounts for multiple time intervals, and the significance level (α) is set at 0.05, with a power of 80%, confidence interval (CI) of 95%, a margin of error (ME) of 5%. 76 specimens (38 for conventional PMMA, 38 for G-PMMA)
  • Subgroups: Each group will have thermocycled and non-thermocycled samples to assess durability.

SAMPLING TECHNIQUE:

Stratified sampling followed by systematic division.

  • Methodology:
  • Thermocycling: 2000 cycles (5°C-55°C) simulating oral temperature variations

Data Collection:

A metal bar mold (65 mm × 10 mm × 3 mm) will be designed using Exocad CAD software and 3D-printed from CoCr material using Selective Laser Melting (SLM). After fabrication, the bar will be used to create a silicone mold, which will then be invested in dental plaster to prepare the final mold for specimen curing. Graphene oxide (GO) will be chemically reduced, purified, dried, and mixed into PMMA powder. The acrylic resin will then be packed into the mold and processed via short curing cycle (74°C for 2 hours, 100°C for 1 hour). Then all the specimen will be prepared, thermocycle and ready for flexural strength and flexural modulus.

  • Data Analysis: The data will be evaluated using the statistical package for social sciences (SPSS version 29, IBM, Chicago, Illinois United States). Descriptive statistics will be evaluated by mean, standard deviation, median, interquartile range of flexural strength, flexural modulus for PMMA, and GPMMA. Shapiro-Wilk test will be used to check the normality of the data distribution. For interferential statistics, Kruskal Wallis or ANOVA will be used with factors of loading force (N) and deflection (Y) between G-PMMA and conventional PMMA. Post-hoc analysis will be performed by Bonferroni or Tukey's test. In order to assess the effect of the external environment, the cofounding variable in this study will be thermocycling, which will influence the flexural strength and flexural modulus of PMMA and graphene-reinforced PMMA samples. A Chi-square or independent t-test will be used to analyze the impact of the cofounding variable, thermocycling, on flexural strength and modulus. The level of significance will be set at p < 0.05.

Rationale:

This study aims to determine whether graphene reinforcement improves the mechanical properties of PMMA, potentially leading to stronger and more fracture-resistant dentures. The findings could contribute to the development of more durable denture base materials with enhanced longevity and performance.

Being tested
Graphene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GrapheneOther

    The study follows an in-vitro experimental design with 76 specimens divided into two groups (conventional PMMA and G-PMMA). These samples will be further divided into two group, the one which undergo thermocycling (simulating oral temperature changes) and the other which don't undergo thermocycling. Flexural strength and modulus will be tested on all these by using a three-point bending test.

Study groups in NCT06856239
Study groupRoleWhat they receive
PMMA(polymethyl methacrylate)No interventionPolymethyl methacrylate (PMMA), which was invented by Dr. Walter Wright1 in 1937, and is now one of the most widely used denture base materials. Polymethyl methacrylate (PMMA) has gained popularity due to its low cost, adequate mechanical strength, acceptable aesthetics, good dimensional stability, and biocompatibility. However, it has low flexural strength, fatigue fracture, and impact strength which can lead to fracture of the prosthesis.
G-PMMA( Graphene-polymethyl methacrylate)ExperimentalGraphene was first invented by Novoselov et al,16 Graphene is a two dimensional (2D), monolayer sp2 hybridized carbon atoms and recognized as the thinnest material in the universe. Comparing it to other traditional nanofillers, its large surface area, tensile strength, flexibility, strong thermal and electrical conductivity, and low coefficient of thermal expansion give it a better result.17 Recent studies have discovered that graphene and its derivatives, which include graphene oxide and reduced graphene oxide, have better outcomes as compared to conventional materials
Receives: Other: Graphene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flexural strength and Flexural modulus

    Outcome Measure 1: Flexural Strength (MPa) The flexural strength of the specimens will be measured using a three-point bending test on a universal testing machine (Testometric testing machine, model VB50-300, Rochdale, Greater Manchester, United Kingdom).

    A load of 0N at a crosshead speed of 2 mm/min will be applied. The force will be increased until the specimens fracture. The maximum force (N) applied before fracture will be recorded to calculate the flexural strength (MPa).

    Outcome Measure 2: Flexural Modulus (MPa) The flexural modulus of the specimens will be tested using a universal testing machine (Testometric testing machine, model VB50-300, Rochdale, Greater Manchester, United Kingdom).

    A constant load of 0N at a crosshead speed of 2 mm/min will be applied. The load (N) and deflection (Y) will be recorded using WinTest software. The initial slope of the load-deflection curve (elastic region) will be used to determine flexural modulus (MPa).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start24 Feb 2025
  3. Primary completion25 Dec 2025 (estimated)
  4. Study completion25 Jan 2026 (estimated)

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06856239
Sponsor's protocol ID
AltamashWZ
Status last verified
Nov 2025
First submitted
10 Feb 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Di Carlo S, De Angelis F, Brauner E, Pranno N, Tassi G, Senatore M, Bossu M. Flexural strength and elastic modulus evaluation of structures made by conventional PMMA and PMMA reinforced with graphene. Eur Rev Med Pharmacol Sci. 2020 May;24(10):5201-5208. doi: 10.26355/eurrev_202005_21301.

    PubMed 32495852

Questions about this trial

What is this clinical trial studying?

A study testing Graphene in people with Dentures and Denture,Complete, run by Altamash Institute of Dental Medicine at 2 sites in Pakistan.

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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

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?

Flexural strength and Flexural modulus (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06856239, which also lists 1 linked publication.

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 19 Nov 2025.

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