Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03693066
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2018-09-28
Brief Title:
Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion
Sponsor:
Izmir Katip Celebi University
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
Effectiveness of the Ozone Application in Two-Visit Indirect Pulp Therapy of Permanent Molars With Deep Carious Lesion
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ozone
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 disinfectantcontrol with 60s 2 chlorhexidine digluconateCHX or 60s ozone application In four different stage after initial excavation ozoneCHX 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
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 disinfectantcontrol with 60s 2 chlorhexidine digluconateCHX or 60s ozone application In four different stage after initial excavation ozoneCHX 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 050 significance level This study conducted with 49 female and 56 male patients aged between 6-13 years old average 972 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 2100 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 brownblack 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 ozonechlorhexidine 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 No16 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
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 2100 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 brownblack 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 ozonechlorhexidine 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 No16 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None