TreatmentNCT05291195

Treatment of Young Permanent Teeth With Different Adjuvant Approaches

A study testing Laser-device group, Essential Oil and Sodium hypochlorite group in people with Treatment and Periodontitis, Apical, run by University of Belgrade at 1 site in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 7 to 18 years
Conditions the study is for: Treatment, Periodontitis, Apical, Necrotic Pulp
What is being tested?: Laser-device group, Essential Oil and Sodium hypochlorite group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSerbia
Study dates: 1 Feb 2018to 1 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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;

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Serbia1 site

School of Dental Medicine, University of Belgrade
Belgrade, 11000

Other trials in Serbia

About this study

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

Read the 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.

Conditions: Treatment, Periodontitis, Apical, Necrotic Pulp
Being tested: Laser-device group, Essential Oil, Sodium hypochlorite group
Keywords: young permanent teeth, periodontitis apical, treatment
Medical subject headings: Periapical Periodontitis, Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laser-device groupDevice
Also called Laser
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.
Essential OilDrug
Also called EO
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)
Sodium hypochlorite groupDrug
Also called NaOCl group
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).

Study groups in NCT05291195
Study group	Role	What they receive
Laser-devices group	Experimental	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). Receives: Device: Laser-device group; Drug: Sodium hypochlorite group
Sodium hypochlorite	Experimental	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). Receives: Drug: Sodium hypochlorite group
Essential oil	Experimental	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) Receives: Drug: Essential Oil; Drug: Sodium hypochlorite group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months
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.
Measured: 6 months

Secondary outcomes (1)

Radiography record of periapical lesion healing
Radiography record of periapical lesion taken by parallel long cone beam technique
Measured: Change baseline radiography record at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20181 Feb 2022

First posted22 Mar 2022
Study start1 Feb 2018
Primary completion15 Oct 2021
Study completion1 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for TreatmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05291195
Sponsor's protocol ID: 36/7
Status last verified: Jan 2022
First submitted: 17 Feb 2022
Last updated: 22 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Gained results are planned to be published in international journals.

Publications

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.
PubMed 15085044
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.
PubMed 29692827
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.
PubMed 26872127
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.
PubMed 23168798
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.
PubMed 32707220

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05291195
Acronym / sponsor ID: 36/7
Conditions: Treatment, Periodontitis, Apical, Necrotic Pulp
Keywords: young permanent teeth, periodontitis apical, treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of BelgradeUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 1 Feb 2022 (actual)
First posted: 22 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Laser-devices group	Experimental	Device: Laser-device group, Drug: Sodium hypochlorite groupMechanico-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).
Sodium hypochlorite	Experimental	Drug: Sodium hypochlorite groupMechanico-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).
Essential oil	Experimental	Drug: Essential Oil, Drug: Sodium hypochlorite groupMechanico-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)

Who may qualify

Ages: 7 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (3 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laser-device groupAlso: LaserAfter 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.	Device	Laser-devices group
Essential OilAlso: EOAfter 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)	Drug	Essential oil
Sodium hypochlorite groupAlso: NaOCl groupMechanico-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).	Drug	Essential oil, Laser-devices group, Sodium hypochlorite

Primary outcome

Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment
Time frame: 6 months
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
Time frame: 6 months
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.

1 secondary outcome

Radiography record of periapical lesion healing
Time frame: Change baseline radiography record at 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
Background: PubMed 15085044Banchs 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.
Background: PubMed 29692827Mohammadi 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.
Background: PubMed 26872127Yun 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.
Background: PubMed 23168798Cheng 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.
Background: PubMed 32707220Marinkovic 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.
Individual participant dataSharing planned: Yes. Gained results are planned to be published in international journals.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dejan Markovic, Professor study chair

University of Zagreb

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laser-device group, Essential Oil and Sodium hypochlorite group in people with Treatment and Periodontitis, Apical, run by University of Belgrade at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291195, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.