Clinical trial NCT05291195: Treatment of Young Permanent Teeth With Different Adjuvant Approaches
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment
Periodontitis, Apical
Necrotic Pulp
Keywords: young permanent teeth
periodontitis apical
treatment
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Number of teeth without bacteria load after laser-devices and essential oil in endodontic treatment
timeFrame: 6 months
measure: Number of teeth without bacteria load after sodium hypochlorite (NaOCl) in endodontic treatment
timeFrame: 6 months
Secondary outcomes:
measure: Radiography record of periapical lesion healing
timeFrame: Change baseline radiography record at 6 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine, University of Belgrade
Study officials:
affiliation: University of Zagreb
name: Dejan Markovic, Professor
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
citation: 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.