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Treatment of Young Permanent Teeth With Different Adjuvant Approaches

Primary Purpose

Treatment, Periodontitis, Apical, Necrotic Pulp

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Laser-device group
Essential Oil
Sodium hypochlorite group
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment focused on measuring young permanent teeth, periodontitis apical, treatment

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Had signed informed consent by the parents or legal guardian ;
  • Systemically healthy children;
  • Had not been submitted to antibiotic therapy in the previous 3 months;
  • Had a least one young permanent anterior tooth (incisor or canine) or the first premolar with pulp necrosis and presence of a chronic periapical lesion (CPP);
  • Had no endodontic treatment of the selected tooth;
  • Had no signs of an acute condition;

Exclusion Criteria:

  • Presence of systemic diseases such as diabetes mellitus, asthma, chronic infections, immunosuppressive diseases or other that could compromise the patient immune system
  • Use anti-inflammatory or immunosuppressive therapy in the last 6 months;
  • Patients with antibiotic prophylactic requirements before dental treatment;

Sites / Locations

  • School of Dental Medicine, University of Belgrade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Laser-devices group

Sodium hypochlorite

Essential oil

Arm Description

Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite. Afterwards, depending on allocations, in the laser devices group, adjuvant treatment approaches were be performed by means of laser devices either photodynamic therapy (HELBO, Photodynamic Systems GmbH), or high power diode laser (940nm, Biolase).

Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite (pH 12), at room temperature (21 degrees Celsius).

Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite (pH 12), at room temperature (21 degrees Celsius). Depending on allocations, in the essential oil group, the canals were be treated with adjuvant essential oil of Cymbopogon martinii and Thymus vulgaris (Herba oils, Herba doo, Belgrade, Serbia)

Outcomes

Primary Outcome Measures

Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment
The number of teeth without isolated bacteria load were assessed. Microbiological samples from the root canals were collected immediately after accessing the canal, following endodontic treatment, and after the adjuvant treatments in allocated groups (Photodynamic therapy or Diode laser or Essential oil). The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay.
Number of teeth without bacteria load after sodium hypochlorite (NaOCl) in endodontic treatment
The number of teeth without isolated bacteria load were assessed after sodium hypochlorite irrigation in each group (Laser-device, Essential oil and Sodium hypochlorite). Microbiological samples from the root canals were collected immediately after accessing the canal, following the endodontic treatment. The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay.

Secondary Outcome Measures

Radiography record of periapical lesion healing
Radiography record of periapical lesion taken by parallel long cone beam technique

Full Information

First Posted
February 17, 2022
Last Updated
March 11, 2022
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT05291195
Brief Title
Treatment of Young Permanent Teeth With Different Adjuvant Approaches
Official Title
Treatment of Chronic Periapical Periodontitis of Young Permanent Teeth by Means of Three Adjuvant Treatment Approaches: A Prospective Comparative Microbiological and Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

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

5. Study Description

Brief Summary
To determine microbiology assessment of infected root canal in young permanent teeth, as well as antimicrobial efficiency of different adjuvant treatment modalities including photodynamic therapy (PDT), high-power diode laser, and essential oils following mechanic-chemical treatment in the treatment of periapical periodontitis in these teeth.
Detailed Description
To determine antimicrobial efficiency of adjuvant photodynamic therapy (PDT) and high-power diode laser, and essential oils in the treatment of chronic periapical periodontitis in young permanent teeth. Material and Methods: Young permanent teeth with chronic periapical periodontitis were selected and randomly divided into tests and control groups. Adjuvant treatment approaches were randomly performed following standard mechanical-chemical endodontic treatment: Experimental laser-device 1, PDT group: adjuvant PDT (n=10) Experimental laser-device 2, Diode laser (940 nm, 1W) (n=10) Experimental essential oil (n=10) Experimental sodium hypochlorite (NaoCL) group (n= 10) solely mechanical instrumentation with 1.5 % of NaOCl irrigation was performed (positive control). Afterwards, each root canal was filled with calcium hydroxide, and definitive obturation was done seven days respectively. Microbiological analyses of root canals were assessed after accessing the canal (sample 1), following mechanical-chemical treatment (sample 2), and adjuvant treatment approaches (sample 3). The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay. To evaluate the efficiency of treatment modalities, radiography records were additionally used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment, Periodontitis, Apical, Necrotic Pulp
Keywords
young permanent teeth, periodontitis apical, treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Laser-devices group
Arm Type
Experimental
Arm Description
Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite. Afterwards, depending on allocations, in the laser devices group, adjuvant treatment approaches were be performed by means of laser devices either photodynamic therapy (HELBO, Photodynamic Systems GmbH), or high power diode laser (940nm, Biolase).
Arm Title
Sodium hypochlorite
Arm Type
Experimental
Arm Description
Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite (pH 12), at room temperature (21 degrees Celsius).
Arm Title
Essential oil
Arm Type
Experimental
Arm Description
Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite (pH 12), at room temperature (21 degrees Celsius). Depending on allocations, in the essential oil group, the canals were be treated with adjuvant essential oil of Cymbopogon martinii and Thymus vulgaris (Herba oils, Herba doo, Belgrade, Serbia)
Intervention Type
Device
Intervention Name(s)
Laser-device group
Other Intervention Name(s)
Laser
Intervention Description
After each instrumentation, the root canals were irrigated with 1.5 % sodium hypochlorite (NaOCl). Depending on allocations, in the laser-device groups, the adjuvant treatment approaches were performed either by means of photodynamic therapy (HELBO, Photodynamic Systems GmbH) or high power diode laser (940nm, Biolase ® Technology, CA, USA). Performing photodynamic therapy the root canals were filled with the phenothiazine chloride (HELBO® Endo Blue, Bredent, Germany) for 2 min following irradiation of diode laser (HELBO® TheraLite Laser (λ = 660 nm, power = 100 mW)) for 60 s. Performing only diode laser the root canals were be irrigated with a diode laser (λ = 940 maximal power 10W) for 60 s.
Intervention Type
Drug
Intervention Name(s)
Essential Oil
Other Intervention Name(s)
EO
Intervention Description
After each instrumentation, the root canals were irrigated with 1.5 % sodium hypochlorite (NaOCl). Depending on allocations, in the EO group, the adjuvant treatment approaches were performed either by means of essential oil (Cymbopogon martinii and Thymus vulgaris, Herba oils, Herba d.o.o, Belgrade, Serbia)
Intervention Type
Drug
Intervention Name(s)
Sodium hypochlorite group
Other Intervention Name(s)
NaOCl group
Intervention Description
Mechanico-chemical root canal preparation and root canal disinfection were be performed by means of mechanic-chemical methods including hand instruments followed by 1.5% sodium hypochlorite (pH 12), at room temperature (21 degrees Celsius).
Primary Outcome Measure Information:
Title
Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment
Description
The number of teeth without isolated bacteria load were assessed. Microbiological samples from the root canals were collected immediately after accessing the canal, following endodontic treatment, and after the adjuvant treatments in allocated groups (Photodynamic therapy or Diode laser or Essential oil). The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay.
Time Frame
6 months
Title
Number of teeth without bacteria load after sodium hypochlorite (NaOCl) in endodontic treatment
Description
The number of teeth without isolated bacteria load were assessed after sodium hypochlorite irrigation in each group (Laser-device, Essential oil and Sodium hypochlorite). Microbiological samples from the root canals were collected immediately after accessing the canal, following the endodontic treatment. The microbiological identification and quantification were provided by MALDI -TOF spectrometry and plate count assay.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiography record of periapical lesion healing
Description
Radiography record of periapical lesion taken by parallel long cone beam technique
Time Frame
Change baseline radiography record at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Had signed informed consent by the parents or legal guardian ; Systemically healthy children; Had not been submitted to antibiotic therapy in the previous 3 months; Had a least one young permanent anterior tooth (incisor or canine) or the first premolar with pulp necrosis and presence of a chronic periapical lesion (CPP); Had no endodontic treatment of the selected tooth; Had no signs of an acute condition; Exclusion Criteria: Presence of systemic diseases such as diabetes mellitus, asthma, chronic infections, immunosuppressive diseases or other that could compromise the patient immune system Use anti-inflammatory or immunosuppressive therapy in the last 6 months; Patients with antibiotic prophylactic requirements before dental treatment;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Markovic, Professor
Organizational Affiliation
School of Dental Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
School of Dental Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Gained results are planned to be published in international journals.
IPD Sharing Time Frame
From 2022. to 2032.
IPD Sharing Access Criteria
The investigators will be shared analyzed outcomes and procedure protocols, as well as microbiological analyses methods.
Citations:
PubMed Identifier
15085044
Citation
Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. doi: 10.1097/00004770-200404000-00003.
Results Reference
background
PubMed Identifier
29692827
Citation
Mohammadi Z, Jafarzadeh H, Shalavi S, Yaripour S, Sharifi F, Kinoshita JI. A Review on Triple Antibiotic Paste as a Suitable Material Used in Regenerative Endodontics. Iran Endod J. 2018 Winter;13(1):1-6. doi: 10.22037/iej.v13i1.17941.
Results Reference
background
PubMed Identifier
26872127
Citation
Yun KH, Lee HS, Nam OH, Moon CY, Lee JH, Choi SC. Analysis of bacterial community profiles of endodontically infected primary teeth using pyrosequencing. Int J Paediatr Dent. 2017 Jan;27(1):56-65. doi: 10.1111/ipd.12226. Epub 2016 Feb 12.
Results Reference
background
PubMed Identifier
23168798
Citation
Cheng X, Guan S, Lu H, Zhao C, Chen X, Li N, Bai Q, Tian Y, Yu Q. Evaluation of the bactericidal effect of Nd:YAG, Er:YAG, Er,Cr:YSGG laser radiation, and antimicrobial photodynamic therapy (aPDT) in experimentally infected root canals. Lasers Surg Med. 2012 Dec;44(10):824-31. doi: 10.1002/lsm.22092. Epub 2012 Nov 20.
Results Reference
background
PubMed Identifier
32707220
Citation
Marinkovic J, Culafic DM, Nikolic B, Dukanovic S, Markovic T, Tasic G, Ciric A, Markovic D. Antimicrobial potential of irrigants based on essential oils of Cymbopogon martinii and Thymus zygis towards in vitro multispecies biofilm cultured in ex vivo root canals. Arch Oral Biol. 2020 Sep;117:104842. doi: 10.1016/j.archoralbio.2020.104842. Epub 2020 Jul 16.
Results Reference
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Treatment of Young Permanent Teeth With Different Adjuvant Approaches

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