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Completed

NCT Number: NCT05291195

Treatment of Young Permanent Teeth With Different Adjuvant Approaches

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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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Laser-device group

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.

Other names: Laser

Essential Oil

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)

Other names: EO

Sodium hypochlorite group

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).

Other names: NaOCl group

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Radiography record of periapical lesion healing

    Time frame: Change baseline radiography record at 6 months

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

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Treatment of Chronic Periapical Periodontitis of Young Permanent Teeth by Means of Three Adjuvant Treatment Approaches: A Prospective Comparative Microbiological and Clinical Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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