Arresting Carious Lesions With Minimal Intervention Techniques

NCT06388746 | Not Yet Recruiting

• 1 other identifier: NKUA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (2)

• clinical success

  Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.

  6 and 12 month post-treatment

• radiographic success

  Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.

  12 month post-treatment

Secondary Outcomes (2)

• Longevity and the quality of the final restoration

  6 and 12 months post-treatment

• Patient's acceptance

  immediately post-treatment

Study Arms (2)

Caries removal group

EXPERIMENTAL

Cavitated lesion will be isolated with cotton rolls and air-dried. Gel will be placed in the cavity and kept there for 60 seconds to allow for the decayed tissue to become softer. The softened tissue will be removed with a hand instrument. The gel will be reapplied, until complete removal of the carious tissue is achieved. Teeth will be restored using a high viscosity glass ionomer cement.

Other: BRIX3000®

Caries arrest group

ACTIVE COMPARATOR

Cavitated lesion will be isolated with cotton rolls and air-dried. One drop of component 1 (38% Silver Fluoride (AgF) in water) will be applied for 60 seconds using a microbrush, followed by two drops of component 2 (potassium iodide) for 90 seconds. Teeth will be restored using a high viscosity glass ionomer cement.

Other: Riva Star Aqua, SDI Limited, Australia

Interventions

BRIX3000® OTHER

A gel that when applied to the tooth completely removes carious tissues in a chemo mechanical way without rotary instruments. It contains an enzyme that has bactericidal, bacteriostatic and anti-inflammatory properties and proteolytic properties that help soften and break down decayed tissue without destroying the underlying healthy collagen fibers.

Caries removal group

Riva Star Aqua, SDI Limited, Australia OTHER

A solution that contains 44,800 ppm F and 253,870 ppm Ag. It acts as a fluoride storage for the acid challenges, while inhibites demineralization of hydroxyapatite crystals and preserves collagen from degradation in demineralized tissues.

Caries arrest group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.

You may not qualify if:

• Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sotiria Gizani, Assoc Prof

  Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sotiria Gizani, Assoc Prof

CONTACT

2107461233; sotiriagizani@gmail.com

Kyriaki Seremidi, Assist Prof

CONTACT

kseremid@uoa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04