Treatment of Young Permanent Teeth With Different Adjuvant Approaches

Not Applicable

Completed

• Conditions: Necrotic Pulp; Periodontitis, Apical; Treatment
• Interventions: Device: Laser-device group; Drug: Essential Oil; Drug: Sodium hypochlorite group

• Registration Number: NCT05291195
• Lead Sponsor: University of Belgrade

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:

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2021-10-15
• Status Verified: 2022-01
• Study Completion: 2022-02-01
• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-11
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-devices group	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. 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	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).
Essential oil	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). 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)
Laser-devices group	Laser-device 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).
Essential oil	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)

Primary Outcome Measures

Name	Time	Method
Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment	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	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 Outcome Measures

Name	Time	Method
Radiography record of periapical lesion healing	Change baseline radiography record at 6 months	Radiography record of periapical lesion taken by parallel long cone beam technique

Trial Locations

Locations (1)

School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia