search
Back to results

Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish

Primary Purpose

Root Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
S-PRG barrier coat
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Caries

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Teeth with primary root surface caries (active dentin carious le-sions)
  • Teeth with gum recession.
  • Teeth are vital according to pulp-sensitivity tests.
  • Controlled gingival or periodontal conditions.

Exclusion Criteria:

  • Retained deciduous teeth; as the research is targeting only per-manent teeth.
  • Teeth with previous restorations which may add another varia-ble to the study (type of old restorative material, extent of re-current caries).
  • Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis.
  • Negative sensitivity tests, periapical radiolucencies, and sensi-tivity to axial or lateral percussion indicating pulp necrosis.
  • Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    patients with root carious lesions will be treated by SDF varnish

    patients with root carious lesions will be treated by PRG barrier coat.

    Arm Description

    Silver diamine fluoride (SDF) contains high concentrations of silver and fluoride ions, which prevents and arrests root caries, as well as dentin caries in the primary teeth of young children. Unlike other fluoride products that mainly reduce the formation of new carious lesions, 38% SDF is an effective agent that can efficiently arrest the carious process, remineralize the decayed dental tissues, and protect the tooth structure against the for-mation of new caries lesions. The use of SDF can result in more caries-resistant tooth structures.

    PRG barrier coat is a Giomer varnish from Shofu. It is a light cured Surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix. It has an immediate and long lasting effect. The (S-PRG) favors the re-lease of fluoride ions and its recharging that aid in remineraliza-tion and protection of the tooth structure in a way similar to the glass ionomer. The fluoride ions aid in the neutralization of the acidity of the oral cavity and decrease the plaque accumulation

    Outcomes

    Primary Outcome Measures

    Evaluation of caries arrest
    Evaluation of caries arrest by visual tactile evaluation. (mean number of arrested carious lesions that become hard, smooth and free from plaque post application of both SDF and S-PRG varnishes).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05509920
    Brief Title
    Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish
    Official Title
    Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish Versus SDF Varnish Over a Period of 1 Year Follow up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Guidelines proved that arresting and remineralization of the root surface caries is better than weakening the tooth structure and restoring it. Manufacturer claims that PRG Barrier Coat effectively treats dental hypersensitivity by providing immediate and long-lasting relief. Also has the effect of eliminating the activity and sur-vival of pathogenic bacteria and hardening the dentin tissue of the affected areas.
    Detailed Description
    A light-cured varnish with extended protection time of up to 6 months, PRG barrier coat incorporates proprietary GIOMER tech-nology, "Surface Pre-Reacted Glass" for high fluoride release and re-charge, continuous release of fluoride, strontium, boron, sodium, aluminum, and zinc, acid neutralization and anti-plaque benefits with excellent self-adhesive abilities. The new material could be an alter-native to SDF varnish in root caries arrest to overcome its unfavor-able color and taste. Products containing S-PRG fillers have been developed in a wide variety of areas such as tooth surface coating materials, seal-ants, restoration resins and dentifrices. The use of these materials is also expected to have the effect of improving the properties of enamel. In this seminar, we will introduce a new caries prevention using S-PRG filler The eluted ions from the S-PRG filler containing materials exhibit various functions, such as prohibition of biofilm attachment, anti-demineralization, remineralization, modification of apatite crystal, and acid-buffering effect. Each ion was confirmed its function. Par-ticularly, Strontium, Borate and Fluoride ions were involved during calcium phosphate nucleation to form modified nano-hydroxyapatite. The acid buffering effect was shown with the borate ion. As the results of those effects of ions, the various materials with S-PRG technology were proven to con-tribute to increase the acid resistance and the caries prevention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Root Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with root carious lesions will be treated by SDF varnish
    Arm Type
    Active Comparator
    Arm Description
    Silver diamine fluoride (SDF) contains high concentrations of silver and fluoride ions, which prevents and arrests root caries, as well as dentin caries in the primary teeth of young children. Unlike other fluoride products that mainly reduce the formation of new carious lesions, 38% SDF is an effective agent that can efficiently arrest the carious process, remineralize the decayed dental tissues, and protect the tooth structure against the for-mation of new caries lesions. The use of SDF can result in more caries-resistant tooth structures.
    Arm Title
    patients with root carious lesions will be treated by PRG barrier coat.
    Arm Type
    Experimental
    Arm Description
    PRG barrier coat is a Giomer varnish from Shofu. It is a light cured Surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix. It has an immediate and long lasting effect. The (S-PRG) favors the re-lease of fluoride ions and its recharging that aid in remineraliza-tion and protection of the tooth structure in a way similar to the glass ionomer. The fluoride ions aid in the neutralization of the acidity of the oral cavity and decrease the plaque accumulation
    Intervention Type
    Other
    Intervention Name(s)
    S-PRG barrier coat
    Intervention Description
    S-PRG filler was the best composition of compressive strength and F- and B release acid buffering capacity. It was found to be the most promising for use as a novel cement.
    Primary Outcome Measure Information:
    Title
    Evaluation of caries arrest
    Description
    Evaluation of caries arrest by visual tactile evaluation. (mean number of arrested carious lesions that become hard, smooth and free from plaque post application of both SDF and S-PRG varnishes).
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Teeth with primary root surface caries (active dentin carious le-sions) Teeth with gum recession. Teeth are vital according to pulp-sensitivity tests. Controlled gingival or periodontal conditions. Exclusion Criteria: Retained deciduous teeth; as the research is targeting only per-manent teeth. Teeth with previous restorations which may add another varia-ble to the study (type of old restorative material, extent of re-current caries). Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis. Negative sensitivity tests, periapical radiolucencies, and sensi-tivity to axial or lateral percussion indicating pulp necrosis. Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish

    We'll reach out to this number within 24 hrs