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AzTrials

Reversible PulpitisPhase 3NCT04365270

Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

A Phase 3 study testing Glass Ionomer, Chitosan Low Molecular Weight (20-200 Mpa.S) and Chlorhexidine Diacetate in people with Reversible Pulpitis and Pulpitis, run by Ain Shams 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
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Trial summary

The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Reversible Pulpitis, Pulpitis, Caries,Dental
What is being tested?
Glass Ionomer, Chitosan Low Molecular Weight (20-200 Mpa.S) and Chlorhexidine Diacetate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteEgypt
Study dates
15 Jan 2019to 5 Jan 2021
Phase
Phase 3
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 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The teeth will be primary molars selected from patients presented to the outpatient clinic that are
  • Healthy patients.
  • Age: 4-8 years.
  • Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm).

Who cannot join

  • Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
  • Children with systemic diseases.
  • Patients with history of active para-functional oral habits, xerostomia.
  • Patients who will have difficulties in cooperating.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry, Ain Shams University

    Cairo, 1156

Other trials in Egypt

About this study

Official title: The Antimicrobial Activity and Clinical Performance of Chitosan-modified Glass Ionomer: A Randomized Clinical Trial

The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars

Read the detailed description

Participants will be recruited from the acquitted to the clinic of pediatric dentistry department , Faculty of Dentistry of Ain Shams University. random allocation of the participants where indirect pulp capping is indicated so that modified Glass ionomer would be used as the filling material.

partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity.

In a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.

Being tested
Glass Ionomer, Chitosan Low Molecular Weight (20-200 Mpa.S), Chlorhexidine Diacetate, Titanium Dioxide
Keywords
Glass ionomer, Chitosan, Titanium dioxide, Titanium dioxide nanoparticles, Chlorhexidine, indirect pulp capping, Alternative restorative technique, stepwise caries excavation, antibacterial restorative, incomplete caries removal, primary molars, early childhood caries
Medical subject headings
Pulpitis, Dental Caries

What participants receive

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

  • Glass IonomerDrug

    Also called Fuji IX

    Glass ionomer filling material would be modified accordingly or used as is

  • Chitosan Low Molecular Weight (20-200 Mpa.S)Drug

    Also called Aldrich, cat#448869, lot #STBG9041

    deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying

  • Chlorhexidine DiacetateDrug

    Also called chlorhexidine acetate

    Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716

  • Titanium DioxideDrug

    Also called Titanium(IV) oxide

    Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332

Study groups in NCT04365270
Study groupRoleWhat they receive
Chitosan Glass ionomerExperimentalpurified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid to be used to modify the stock liquid provided with the glassionomer Fuji IX to have 10% v/v chitosan. will be placed in the prepared cavity over the last layer of caries
Receives: Drug: Glass Ionomer; Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)
Chitosan/Titanium dioxide nanoparticles Glass ionomerExperimentalThe stock liquid provided with the glassionomer Fuji IX will be modified with 10%v/v purified low molecular weight and viscosity chitosan will be dissolved in 0.1 mol/L acetic acid. The Powder will be modified with 3% titanium dioxide nanoparticles will be placed in the prepared cavity over the last layer of caries
Receives: Drug: Glass Ionomer; Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Titanium Dioxide
Chlorhexidine glass ionomerActive comparatorChlorhexidine Diacetate will be added to the powder of Fuji IX with 0.5% v/v
Receives: Drug: Glass Ionomer; Drug: Chlorhexidine Diacetate
Glass ionomerPlacebo comparatorStock powder and liquid Fuji IX from GC japan
Receives: Drug: Glass Ionomer

What is being measured

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

  1. Antibacterial

    Dentin samples incubated on 2 culture mediums and total bacterial count by counting colony forming units will be counted. Higher number means Less antibacterial effect

    Measured: 9 months

  2. Clinical performance

    "Modified United States Public Health Service Ryge Criteria" for Direct Clinical Evaluation and rating of Restoration.measuring color match, anatomic contour, marginal integrity, cavosurface marginal discoloration, secondary caries, surface texture, gross fracture.

    each outcome will be graded Alpha(A) for the highest score, Bravo(b) for moderate score, and Charlie(C) for the lowest score.

    Measured: followup 9 months

Timeline

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

  1. First posted28 Apr 2020
  2. Study start15 Jan 2019
  3. Primary completion5 Jan 2021
  4. Study completion5 Jan 2021

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04365270
Sponsor's protocol ID
FDASU-REC IM 011730
Status last verified
Jan 2021
First submitted
6 Dec 2019
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mulder R, Anderson-Small C. Ion release of chitosan and nanodiamond modified glass ionomer restorative cements. Clin Cosmet Investig Dent. 2019 Sep 6;11:313-320. doi: 10.2147/CCIDE.S220089. eCollection 2019.

    PubMed 31686917

  • Wassel MO, Khattab MA. Antibacterial activity against Streptococcus mutans and inhibition of bacterial induced enamel demineralization of propolis, miswak, and chitosan nanoparticles based dental varnishes. J Adv Res. 2017 Jul;8(4):387-392. doi: 10.1016/j.jare.2017.05.006. Epub 2017 May 17.

    PubMed 28560054

  • Ibrahim MA, Meera Priyadarshini B, Neo J, Fawzy AS. Characterization of Chitosan/TiO2 Nano-Powder Modified Glass-Ionomer Cement for Restorative Dental Applications. J Esthet Restor Dent. 2017 Apr;29(2):146-156. doi: 10.1111/jerd.12282. Epub 2017 Feb 12.

    PubMed 28190299

  • Ibrahim MA, Neo J, Esguerra RJ, Fawzy AS. Characterization of antibacterial and adhesion properties of chitosan-modified glass ionomer cement. J Biomater Appl. 2015 Oct;30(4):409-19. doi: 10.1177/0885328215589672. Epub 2015 Jun 15.

    PubMed 26079388

  • Kabil NS, Badran AS, Wassel MO. Effect of the addition of chlorhexidine and miswak extract on the clinical performance and antibacterial properties of conventional glass ionomer: an in vivo study. Int J Paediatr Dent. 2017 Sep;27(5):380-387. doi: 10.1111/ipd.12273. Epub 2016 Oct 21.

    PubMed 27766712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glass Ionomer, Chitosan Low Molecular Weight (20-200 Mpa.S) and Chlorhexidine Diacetate in people with Reversible Pulpitis and Pulpitis, run by Ain Shams 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 4 inclusion and 4 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 12 Jan 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Antibacterial (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT04365270, which also lists 5 linked publications.

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 12 Jan 2021.

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