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NCT Number: NCT06641323

Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries

The aim of this study is to verify, through bacteriological analysis, the efficacy of reducing the bacterial load referred to the presence of Streptococcus Mutans in carious lesions of viable deciduous molars by application of gaseous ozone or ozonized gel.

Patients who meet the eligibility criteria and for whom the legal guardians have signed the informed consent, will undergo treatment of the carious lesion with gaseous ozone or ozonized gel. After selective removal of dentin, a bacterial sample will be taken from the carious surface with a sterile paper cone at time T0; then ozone will be applied for 30 seconds, the surface will be washed with sterile saline and dried with air, a second sample will be taken at time T2; finally, ozone will be applied for another 30 seconds, the surface will be washed with sterile saline and dried with air, a third sample will be taken at time T2.

Patients are then randomised into two groups:

Test group: gaseous ozone (Healozone X4) is applied to the carious lesion for 30 seconds and then for another 30 seconds.

Control group: ozone gel (GeliO3) will be applied to the carious lesion for 30 seconds and then for another 30 seconds.

Changes in the following indices will be assessed at the first visit and when the samples are taken at T0, T1, T2: compliance assessment (FLACC scale), sensitivity test (Schiff Air Index), assessment of lesion severity and extent (ICDAS), assessment of gingival inflammation (GI), assessment of plaque index (PI), assessment of severity of enamel erosion (Bewe index).

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from carious lesion on viable deciduous molar
  • patients' compliance

Exclusion criteria

  • patients with early loss of deciduous molars for carious lesions or orthodontic reasons
  • non-viable deciduous molars
  • deciduous molars with traumatic lesions

Treatment and study plan

Ozonized gel

Other

Administration of Ozonized Gel GeliO3

Ozonized water

Device

Admininstration of Gaseous ozone (Healozone X4)

Primary outcomes

  1. Change in S. mutans counts

    Time frame: Baseline (T0), after 30 seconds (T1) and after 60 seconds (T2)

    Evaluation of Colony forming units (CFU) of bacterials samples after treatment.

Secondary outcomes

  1. Change in FLACC

    Time frame: Baseline (T0), and after 60 seconds (T2)

    The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children with a score of 0 to 2 for each evaluation.

  2. Change in Schiff Air Index

    Time frame: Baseline (T0), and after 60 seconds (T2)

    Scoring criteria:

    0.= the subject does not respond to air stimulation;

    • = the subject responds to stimulation with air but does not require interruption;
    • = the subject responds to stimulation with air and requests interruption or moves away from the stimulus;
    • = the subject responds to stimulation with air, considers the stimulus painful, requests its interruption or moves away from it.

  3. Gingival Index (calculated on Ramfjiord teeth)

    Time frame: Baseline (T0)

    Scoring criteria:

    0 = normal gingiva, no inflammation, no erythema, no bleeding

    • = mild inflammation, slight erythema, minimal superficial alterations, no bleeding
    • = moderate inflammation, erythema, bleeding on probing
    • = severe inflammation, severe erythema and swellling, tendency to spontaneous bleeding, possible ulcers

  4. Plaque Index (calculated on Ramfjiord teeth)

    Time frame: Baseline (T0)

    Scoring criteria:

    0 = no plaque

    • = thin layer of plaque at the gingival margin, detectable only by scraping with a probe
    • = moderate layer of plaque along the gingival margin; free interdental spaces, but plaque is visible to the bare eye
    • = abundant plaque along the gingival margin; plaque-filled interdental spaces.

  5. ICDAS

    Time frame: Baseline (T0)

    Scoring criteria:

    0 = healthy

    • = White/brown stain in dry enamel
    • = White/brown stain on wet enamel
    • = Microcavity in dry enamel <0.5 mm with no visible dentin
    • = Dark dentin shade seen through wet enamel with or without microcavity
    • = Dentin exposure in the cavity> 0.5 mm in the middle of the dry tooth surface
    • = Dentin exposure in cavity greater than half of the tooth surface

  6. Basic Erosive Wear Examination

    Time frame: Baseline (T0)

    Scoring criteria:

    0 = no tooth erosion

    • = superficial enamel loss
    • = hard tissue loss involving < 50% of tooth surface
    • = hard tissue loss involving > 50% of tooth surface

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Ozonized Gel vs Gaseous Ozone Against S. Mutans in Deciduos Molars Caries: Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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