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Status unknownNCT04701320Updated Jan 8, 2021

Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients

A Phase 1 interventional study of Conventional glass ionomer and Nano hydroxyapatite reinforced glass ionomer in Dental Restoration Failure, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Cairo University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?

Read the detailed description

Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies

02

Conditions studied

  • Dental Restoration Failure

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Keywords

  • Glass Carbomer GCP glass fill root caries Clinical perfomance
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • ≥ 50 years old

      • Males or females.
      • Community-dwelling
      • Have five or more of their own teeth
      • With ≥ 1 root caries lesion

Exclusion criteria

Exclusion Criteria:

    • Patients younger than 50 years old

      • Disabilities.
      • Systemic diseases or severe medically compromised.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Glass carbomer

    Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue

    Drug: Nano hydroxyapatite reinforced glass ionomer

  • Active comparator
    Fuji ix

    Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive

    Drug: Conventional glass ionomer

Interventions

  • DrugConventional glass ionomer

    Conventional glass ionomer with enhanced mechanical and esthetic proberties

    Also known as: Fujiix gc corporation

  • DrugNano hydroxyapatite reinforced glass ionomer

    Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure

    Also known as: Glass carbomer

05

What researchers measure

Primary outcomes

  1. Clinical restorative performance Service (USHPS)

    Change in the clinical behavior of the restoration (e.g. anatomical contour, shade match, secondary caries) using modified United State Public Health clinical evaluation assessment method Service (USHPS)

    Time frame: Change from the baseline at 3, 6 and12 months

06

Study locations

1 site
  • Faculty of dentistry
    Cairo, 002, Egypt
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04701320
Lead sponsor
Cairo University
Responsible party
Reham nabil mahmoud (associate lecturer, Cairo University) — Principal investigator
First posted
Jan 8, 2021
Start date
Jul 7, 2019
Primary completion
Jul 7, 2019
Completion
Aug 9, 2021 (estimated)
Last update
Jan 8, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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