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

NCT05509920 | Unknown

• 1 other identifier: Giomer based barrier coat
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Root Caries

Outcome Measures

Primary Outcomes (1)

• 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).

  one year

Study Arms (2)

patients with root carious lesions will be treated by SDF varnish

ACTIVE COMPARATOR

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.

Other: S-PRG barrier coat

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

EXPERIMENTAL

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

Other: S-PRG barrier coat

Interventions

S-PRG barrier coat OTHER

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.

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

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08