Treatment of Young Permanent Teeth With Different Adjuvant Approaches

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-02-01

Brief Summary

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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.

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Detailed Description

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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:

1. Experimental laser-device 1, PDT group: adjuvant PDT (n=10)
2. Experimental laser-device 2, Diode laser (940 nm, 1W) (n=10)
3. Experimental essential oil (n=10)
4. 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

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Treatment Periodontitis, Apical Necrotic Pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Laser-devices 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. 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).

Group Type EXPERIMENTAL

Laser-device group

Intervention Type DEVICE

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.

Sodium hypochlorite group

Intervention Type DRUG

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).

Sodium hypochlorite

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).

Group Type EXPERIMENTAL

Sodium hypochlorite group

Intervention Type DRUG

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).

Essential oil

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)

Group Type EXPERIMENTAL

Essential Oil

Intervention Type DRUG

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 group

Intervention Type DRUG

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).

Interventions

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Laser-device group

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 DEVICE

Essential Oil

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

Sodium hypochlorite 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).

Intervention Type DRUG

Other Intervention Names

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Laser EO NaOCl group

Eligibility Criteria

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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;

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No