Clinical trial NCT05361278: Evaluation of Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
Official title: Evaluation of Irrigation Effectiveness for Gel and Solution of Chlorhexidine in Disinfection Root Canals of Primary Anterior Teeth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Infection, Bacterial
Tooth, Deciduous
Keywords: Anterior Primary Tetth
Infected canals
chlorhexidine
Sodium hypochlorite
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The process of removing bacteria and their products from the root canals is an essential step that is achieved through the combination of mechanical preparation and irrigation with chemicals. However, mechanical preparation alone can not reduce the microbial formations inside root canals, so at least about 35% of the root canal walls remain without the preparation tools reaching them.

Many irrigants were used to irrigate the root canals, as sodium hypochlorite and chlorhexidine are the most famous. Although most studies have proven the effectiveness of sodium hypochlorite with its different concentrations in accomplishing this task, some of them showed the inability of the irrigant fluid to eliminate Enterococcus faecalis inside the canals. These bacteria are highly resistant, and therefore endodontic treatment fails in the long term.

Detailed description: Bacteria and their products play an essential role in the initiation and persistence of endodontic diseases. Therefore, eliminating them and preventing the return of their effectiveness is the desired goal in any successful endodontic treatment in the short and long term.

Due to the fact that mechanical preparation of the root canal alone is not capable of removing the entire bacterial content, chemical irrigants were considered necessary to reduce the number of bacteria and toxins resulting from them. Until now, there is no irrigant capable of removing the entire bacterial content from the root canal.

Despite the many advantages of sodium hypochlorite, several studies have revealed the toxicity of the solution in high concentrations of it, and it tends to cause tissue irritation when it comes into contact with the apical tissues.

Chlorhexidine has been used for a long time in dentistry due to its antibacterial properties, long period of effect, and relatively low toxicity. This has prompted its use as an irrigant and an intra-canal dressing in endodontic treatment.

Eligibility criteria: Inclusion Criteria:

1. Definitely positive or positive ratings of Frank scale.
2. Physiological root resorption no more than the apical third
3. Symptoms or signs of pulpal necrosis with or without radial lesions (swelling - fistua - abnormal movement).
4. At least 2 mm of bone surrounding the permanent bud.
5. Children who have not taken antibiotics in the past 3 months.

Exclusion Criteria:

1. Systematic or mental disorders.
2. Definitely negative or negative ratings of Frankel scale
3. Existence external or internal abnormal absorption.

Primary outcomes:
measure: Logarithmic reduction of bacterial count within the root canal of chlorhexidine solution.
timeFrame: 24 hours after sample incubation
measure: Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine solution.
timeFrame: 24 hours after sample incubation
measure: Logarithmic reduction of bacterial count within the root canal of chlorhexidine gel.
timeFrame: 24 hours after sample incubation
measure: Logarithmic reduction of bacterial count within the root canal of activated chlorhexidine gel.
timeFrame: 24 hours after sample incubation
measure: Logarithmic reduction of bacterial count within the root canal of sodium hypochlorite solution.
timeFrame: 24 hours after sample incubation
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Rahaf ِA kharsa, DDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Mohannad G Laflouf, Phd
role: STUDY_DIRECTOR
References:
citation: Goud S, Aravelli S, Dronamraju S, Cherukuri G, Morishetty P. Comparative Evaluation of the Antibacterial Efficacy of Aloe Vera, 3% Sodium Hypochlorite, and 2% Chlorhexidine Gluconate Against Enterococcus faecalis: An In Vitro Study. Cureus. 2018 Oct 22;10(10):e3480. doi: 10.7759/cureus.3480.
citation: Gomes BP, Ferraz CC, Vianna ME, Berber VB, Teixeira FB, Souza-Filho FJ. In vitro antimicrobial activity of several concentrations of sodium hypochlorite and chlorhexidine gluconate in the elimination of Enterococcus faecalis. Int Endod J. 2001 Sep;34(6):424-8. doi: 10.1046/j.1365-2591.2001.00410.x.
citation: Ruksakiet K, Hanak L, Farkas N, Hegyi P, Sadaeng W, Czumbel LM, Sang-Ngoen T, Garami A, Miko A, Varga G, Lohinai Z. Antimicrobial Efficacy of Chlorhexidine and Sodium Hypochlorite in Root Canal Disinfection: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2020 Aug;46(8):1032-1041.e7. doi: 10.1016/j.joen.2020.05.002. Epub 2020 May 12.
citation: Walia V, Goswami M, Mishra S, Walia N, Sahay D. Comparative Evaluation of the Efficacy of Chlorhexidine, Sodium Hypochlorite, the Diode Laser and Saline in Reducing the Microbial Count in Primary Teeth Root Canals - An In Vivo Study. J Lasers Med Sci. 2019 Fall;10(4):268-274. doi: 10.15171/jlms.2019.44. Epub 2019 Oct 1.
citation: Tirali RE, Bodur H, Ece G. In vitro antimicrobial activity of sodium hypochlorite, chlorhexidine gluconate and octenidine dihydrochloride in elimination of microorganisms within dentinal tubules of primary and permanent teeth. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e517-22. doi: 10.4317/medoral.17566.