Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion
Condition: Ozone; Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the clinical and microbiological effectiveness of the
      ozone application in two-visit indirect pulp therapy.

      Materials and Methods: One hundred and five lower first molar teeth with deep caries lesion
      were included and randomly assigned three groups to apply two-visit indirect pulp therapy.
      Treatment procedure was applied without any disinfectant(control), with 60s 2% chlorhexidine
      digluconate(CHX) or 60s ozone application. In four different stage (after initial excavation,
      ozone/CHX application before the temporary restoration, four months later immediately after
      removing temporary restoration, and final excavation) dentin humidity, consistency and colour
      properties were recorded to evaluate the clinical characteristics of the tissue, and standard
      dentin samples were collected for the microbiological analysis of mutans streptococci,
      lactobacilli and the total number of colony forming units. The data were analyzed by using
      Mann-Whitney-U test for multiple comparisons.
    

Detailed description: 
      A randomized, controlled, clinical trial was designed to evaluate the antibacterial effect of
      ozone application in two-visit indirect pulp therapy. The sample size for this study was
      determined 35 for each group (%82 power, 0.50 significance level). This study conducted with
      49 female and 56 male patients aged between 6-13 years old (average 9.72). The entire patient
      had deep caries lesions with pulp perforation risk at one of the lower first permanent
      molars.

      The vitality of teeth were tested by cold thermal test, necessary clinical and radiographic
      examinations were performed, then the teeth were randomly divided into three treatment groups
      as: two-visit indirect pulp therapy without any disinfectant (control group), two-visit
      indirect pulp therapy with chlorhexidine digluconate application (positive control group),
      and two-visit indirect pulp therapy with gaseous ozone application (experimental group).
      Treatment procedure started with the local anesthesia and isolation of the tooth with
      rubber-dam. The peripheral demineralized dentin and the superficial necrotic dentin were then
      completely removed, and left some caries at the central part. It was decided to leave
      potentially remineralizable affected dentin by hand sensitivity. In control group, the
      remaining caries dentin was covered with calcium hydroxide base material and cavity sealed
      with glass ionomer cement temporarily. In positive control group, following the excavation,
      2% chlorhexidine digluconate was applied to the cavity for 60 seconds using a brush.
      According to the manufacturer instructions, puddled solution was removed with a new brush
      without dry to leave site moist. In experimental group, following the excavation, the cavity
      was exposed to gaseous ozone for 60 seconds, with an ozone delivery system. According the
      manufacturers, HealOzone produces ozone at a fixed concentration of 2,100 ppm. Ozone
      production is stopped if the airtight seal over the tooth is broken during treatment,
      therefore, silicon caps were selected according to the size of each tooth. After the
      disinfectant applications, procedure was completed as aforementioned in the control group for
      these two groups. After four months, the clinical and radiographic examinations were repeated
      in order to assess pathological conditions of the teeth before removed the temporary glass
      ionomer cement and calcium hydroxide base material. Subsequent to this procedure, remaining
      demineralized dentin was completely removed in all groups. Floor of the cavity was then
      covered with calcium hydroxide base material and glass ionomer cement as liner. Final
      restorations were performed with 2-stage self etch bond and composite.

      For the clinical analyses, the consistency, colour and humidity of the dentine were recorded
      at three times: after initial excavation at the first stage (T0), at the end of four months
      period, immediately after removing the calcium hydroxide base at second stage (T2) and after
      final excavation at second stage (T3). The consistency of dentin was determined by probing
      and classified as; very soft, soft, medium hard and hard [8]. The colour of dentin was
      classified as, light yellow, yellow, light brown, dark brown/black. In addition, dentine was
      probed and if moisture leakage was occurred, it was classified as wet or if did not it would
      be classified as dry.

      For the microbiological analyses, dentine samples were taken at four different times: from
      the remain dentine after initial excavation (T0), immediately after ozone/chlorhexidine
      application (T1), at the end of four months period immediately after removing the calcium
      hydroxide base material (T2) and after final excavation (T3). T1 stage did not exist in
      control group, because in this group no disinfectant was used. Clinical photographs were
      taken to ensure that all samples were collected from the same site in all following stages.
      The dentine samples were collected enough to fill the slots of a sterile No.16 round carbide
      bur (SS White Burs, Inc., New Jersey, USA) and the samples were placed into 1 ml
      thioglucolate medium and transported the microbiology laboratory in 2 hours to be analyzed
      for the mutans streptococci, lactobacilli and the total number of colony forming units (CFU).

      The samples were homogenized on a vortex mixer for 15 seconds under laboratory conditions.
      Mitis Salivarius agar as the selective medium for Streptoccus mutans, Rogossa agar for
      Lactobacilli and Brain Hearth agar supplemented %5 blood for the total numbers of CFU were
      used. Samples were incubated anaerobically for 48 hours and the colonies were counted.
    

Intervention name(s): Ozone; chlorhexidine digluconate; Control
Intervention type(s): Other; Other; Other
Intervention description(s): In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as ozone.; In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as chlorhexidine digluconate.
Other intervention name(s): without any cavity disinfectant
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Disinfectants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stepwise excavation; indirect pulp capping; ozone; deep caries