search
Back to results

Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion (ozone)

Primary Purpose

Ozone, Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ozone
chlorhexidine digluconate
Control
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ozone focused on measuring stepwise excavation, indirect pulp capping, ozone, deep caries

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Without signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.)
  • The absence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination;
  • Presence of normal lamina dura and periodontal range, absence of lesion, internal or external resorption or calcification in or around the root in the radiological examination.

Exclusion Criteria:

  • Children with special health care needs
  • Children with dental crowding limiting the child's ability to maintain oral hygiene
  • Teeth with clinical and/ or radiological signs or symptoms of non- vitality
  • Teeth with clinical and radiological signs or symptoms of irreversible pulpitis, or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    ozone

    chlorhexidine digluconate

    Control

    Arm Description

    Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with ozone. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The cavity was exposed to gaseous ozone for 60 seconds, with an ozone delivery system. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement to reopen 4 months later.

    Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with chlorhexidine digluconate. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. 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. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.

    Thirty five molar teeth with deep caries lesion were selected to apply conventional two-visit indirect pulp therapy (control). The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.

    Outcomes

    Primary Outcome Measures

    Changes microbiological count: from baseline to 4 months
    mutans streptococci, lactobacilli and the total number of colony forming units were counted.

    Secondary Outcome Measures

    Changes characteristics of the dentin humidity: from baseline to 4 months
    Dentine was probed and if moisture leakage was occurred, it was classified as wet or if did not it would be classified as dry.
    Changes characteristics of the dentin consistency: from baseline to 4 months
    The consistency of dentin was determined by probing and classified as; very soft, soft, medium hard and hard.
    Changes characteristics of the dentin color: from baseline to 4 months
    The colour of dentin was classified as, light yellow, yellow, light brown, dark brown/black.

    Full Information

    First Posted
    September 28, 2018
    Last Updated
    September 30, 2018
    Sponsor
    Izmir Katip Celebi University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03693066
    Brief Title
    Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion
    Acronym
    ozone
    Official Title
    Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ozone, Caries
    Keywords
    stepwise excavation, indirect pulp capping, ozone, deep caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ozone
    Arm Type
    Experimental
    Arm Description
    Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with ozone. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The cavity was exposed to gaseous ozone for 60 seconds, with an ozone delivery system. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement to reopen 4 months later.
    Arm Title
    chlorhexidine digluconate
    Arm Type
    Active Comparator
    Arm Description
    Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with chlorhexidine digluconate. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. 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. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Thirty five molar teeth with deep caries lesion were selected to apply conventional two-visit indirect pulp therapy (control). The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.
    Intervention Type
    Other
    Intervention Name(s)
    Ozone
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    chlorhexidine digluconate
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    without any cavity disinfectant
    Primary Outcome Measure Information:
    Title
    Changes microbiological count: from baseline to 4 months
    Description
    mutans streptococci, lactobacilli and the total number of colony forming units were counted.
    Time Frame
    Baseline and Four months later
    Secondary Outcome Measure Information:
    Title
    Changes characteristics of the dentin humidity: from baseline to 4 months
    Description
    Dentine was probed and if moisture leakage was occurred, it was classified as wet or if did not it would be classified as dry.
    Time Frame
    Baseline and Four months later
    Title
    Changes characteristics of the dentin consistency: from baseline to 4 months
    Description
    The consistency of dentin was determined by probing and classified as; very soft, soft, medium hard and hard.
    Time Frame
    Baseline and Four months later
    Title
    Changes characteristics of the dentin color: from baseline to 4 months
    Description
    The colour of dentin was classified as, light yellow, yellow, light brown, dark brown/black.
    Time Frame
    Baseline and Four months later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Without signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.) The absence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination; Presence of normal lamina dura and periodontal range, absence of lesion, internal or external resorption or calcification in or around the root in the radiological examination. Exclusion Criteria: Children with special health care needs Children with dental crowding limiting the child's ability to maintain oral hygiene Teeth with clinical and/ or radiological signs or symptoms of non- vitality Teeth with clinical and radiological signs or symptoms of irreversible pulpitis, or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merve Akcay, assoc prof
    Organizational Affiliation
    Izmir Katip Celebi Uni
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion

    We'll reach out to this number within 24 hrs