Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Pomeranian Medical University Szczecin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Caries,Dental

Treatments: Other: ApaCare & Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04147091

KB-0012/102/11

Details and patient eligibility

About

Objectives: to assess the efficiency of three methods of enamel remineralization on initial approximal caries: 1. a nano-hydroxyapatite gel, 2. gaseous ozone therapy 3. combination of a nano-hydroxyapatite gel and ozone.

Materials and Methods: Patients (n=92, age 20-30y) with initial approximal enamel lesions on premolar and molar teeth (n=546) randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both remineralizing gel and ozone therapy. Caries lesions assessed on bitewing radiographs at baseline, after 1 year and after 2 years.

Enrollment: 92 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-initial approximal enamel lesions on premolar and molar teeth

Exclusion criteria

• distal surface of the last tooth in arch, overlapping teeth
• fillings on approximal surfaces of teeth of interest
• ongoing orthodontic therapy with braces or other appliances

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 3 patient groups

domestic nanohydroxyapatite gel ApaCare & Repair

Experimental group

Description:

6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

Treatment:

Other: ApaCare & Repair

in-office ozone therapy OzonyTron

Experimental group

Description:

6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

Treatment:

Other: ApaCare & Repair

both remineralizing gel and ozone therapy

Experimental group

Description:

6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

Treatment:

Other: ApaCare & Repair