Treatment of Young Permanent Teeth With Different Adjuvant Approaches

NCT05291195 | Completed

• 1 other identifier: 36/7
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment; Periodontitis, Apical; Necrotic Pulp

Keywords

young permanent teeth; periodontitis apical; treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Radiography record of periapical lesion healing

  Change baseline radiography record at 6 months

Study Arms (3)

Laser-devices group

EXPERIMENTAL

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).

Device: Laser-device group; Drug: Sodium hypochlorite group

Sodium hypochlorite

EXPERIMENTAL

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).

Drug: Sodium hypochlorite group

Essential oil

EXPERIMENTAL

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)

Drug: Essential Oil; Drug: Sodium hypochlorite group

Interventions

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.

Also known as: Laser

Laser-devices group

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)

Also known as: EO

Essential oil

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).

Also known as: NaOCl group

Essential oil; Laser-devices group; Sodium hypochlorite

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related 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. doi: 10.1097/00004770-200404000-00003.

  PMID: 15085044 BACKGROUND

• 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.

  PMID: 29692827 BACKGROUND

• 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.

  PMID: 26872127 BACKGROUND

• 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.

  PMID: 23168798 BACKGROUND

• 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.

  PMID: 32707220 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Interventions

Lasers; Oils, Volatile

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Oils; Lipids

Study Officials

• Dejan Markovic, Professor

  University of Zagreb

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Research Associate

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 22, 2022
• Study Start: February 1, 2018
• Primary Completion: October 15, 2021
• Study Completion: February 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 2022. to 2032.
• Access Criteria: The investigators will be shared analyzed outcomes and procedure protocols, as well as microbiological analyses methods.

Locations

SE (1)