Treatment of Young Permanent Teeth With Different Adjuvant Approaches

Treatment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291195
• Other study ID #: 36/7
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2022
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 periodontitis in these teeth.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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;

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrotic Pulp
• Periapical Periodontitis
• Periodontitis
• Treatment

Intervention

Device:
• 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 (? = 660 nm, power = 100 mW)) for 60 s. Performing only diode laser the root canals were be irrigated with a diode laser (? = 940 maximal power 10W) for 60 s.

Drug:
• 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)
• 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).

Locations

Country	Name	City	State
Serbia	School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (5)

Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. — View 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. — View Citation

Marinkovic J, Culafic DM, Nikolic B, Ðukanovic 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Secondary	Radiography record of periapical lesion healing	Radiography record of periapical lesion taken by parallel long cone beam technique	Change baseline radiography record at 6 months