Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment

NCT02681276 | Completed

• 1 other identifier: Irrigation 3% NaOCl
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment. Methodology: Consecutive patients referred to a specialist clinic of endodontics are randomly assigned to have the root canal treatment performed with a concomitant irrigation either with a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or necrotic pulps and retreatment cases were included. Root canal treatment procedures varied but followed the routines of the Specialist Clinic of Endodontics, Public Dental Health, Gothenburg, Sweden. Immediately before the root canal filling a microbial sample is taken from the operative field and the root canal. The bacterial samples were processed at the laboratory as outlined by Möller (1966). After each visit each patient was instructed to fill in a questionnaire and assess his or her post-operative pain on a visual analogue scale (VAS), with endpoints 0= "no pain" and 10= "worst imaginable pain", for seven consecutive days. The Fischer's exact test was used for statistical analyses of the differences in outcome between the groups.

Conditions

Pulpitis; Apical Periodontitis

Keywords

Irrigation during root canal treatment; Sodium Hypochlorite

Outcome Measures

Primary Outcomes (1)

• Assessing bacterial growth in the root canal (positive meaning cultivable bacteria present, negative meaning absence of cultivable bacteria)

  Bacterial sampling was taken just before the root canal filling. The sodium hypochlorite solution and the iodine-potassium-iodide were inactivated with 5 % sodium thiosulfate solution for 30 sec. The canals were then filled with VMGA I, dentinal shavings were produced with H files ISO #25. The entire canal content was absorbed by means of charcoal points and transferred to VMGA III.

  Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken.

Secondary Outcomes (1)

• Assessment of post-operative pain using a questionnaire containing 7 visual scales.

  7 consecutive days after each appointment

Study Arms (2)

Irrigation with 3% NaOCl

EXPERIMENTAL

After informed consent the patient was randomly assigned to have the root canal treatment performed with a 3 % NaOCl irrigation during instrumentation. If the patient's first visit was on an uneven date the concentration of the irrigant was 3 %.

Procedure: Irrigation with 3% NaOCl

Irrigation with 0.5% NaOCl

ACTIVE COMPARATOR

After informed consent the patient was randomly assigned to have the root canal treatment performed with a 0.5 % NaOCl irrigation during instrumentation. If the patient's first visit was on an even date the concentration of the irrigant was 0.5 %.

Procedure: Irrigation with 0.5% NaOCl

Interventions

Irrigation with 3% NaOCl PROCEDURE

All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.

Irrigation with 3% NaOCl

Irrigation with 0.5% NaOCl PROCEDURE

All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.

Irrigation with 0.5% NaOCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of and willing to have a root canal treatment
• Diagnosis Pulpitis
• Diagnosis Apical periodontitis.
• If a patient was referred for more than one tooth just the first treated tooth was included in the study.
• The teeth had to be restorable and placement of rubber dam must be possible.

You may not qualify if:

• patient does not understand Swedish
• the tooth will be treated with a retrograde approach

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Göteborg University

Gothenburg, Sweden

Location

Related Publications (15)

• Spencer HR, Ike V, Brennan PA. Review: the use of sodium hypochlorite in endodontics--potential complications and their management. Br Dent J. 2007 May 12;202(9):555-9. doi: 10.1038/bdj.2007.374.

  PMID: 17496870 BACKGROUND

• Ayhan H, Sultan N, Cirak M, Ruhi MZ, Bodur H. Antimicrobial effects of various endodontic irrigants on selected microorganisms. Int Endod J. 1999 Mar;32(2):99-102. doi: 10.1046/j.1365-2591.1999.00196.x.

  PMID: 10371903 RESULT

• Baumgartner JC, Cuenin PR. Efficacy of several concentrations of sodium hypochlorite for root canal irrigation. J Endod. 1992 Dec;18(12):605-12. doi: 10.1016/S0099-2399(06)81331-2.

  PMID: 1298800 RESULT

• Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.

  PMID: 3922900 RESULT

• Fabricius L, Dahlen G, Sundqvist G, Happonen RP, Moller AJ. Influence of residual bacteria on periapical tissue healing after chemomechanical treatment and root filling of experimentally infected monkey teeth. Eur J Oral Sci. 2006 Aug;114(4):278-85. doi: 10.1111/j.1600-0722.2006.00380.x.

  PMID: 16911098 RESULT

• Hand RE, Smith ML, Harrison JW. Analysis of the effect of dilution on the necrotic tissue dissolution property of sodium hypochlorite. J Endod. 1978 Feb;4(2):60-4. doi: 10.1016/S0099-2399(78)80255-6. No abstract available.

  PMID: 277629 RESULT

• Harrison JW, Hand RE. The effect of dilution and organic matter on the anti-bacterial property of 5.25% sodium hypochlorite. J Endod. 1981 Mar;7(3):128-32. doi: 10.1016/S0099-2399(81)80127-6. No abstract available.

  PMID: 6783724 RESULT

• KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.

  PMID: 14342926 RESULT

• Molander A, Warfvinge J, Reit C, Kvist T. Clinical and radiographic evaluation of one- and two-visit endodontic treatment of asymptomatic necrotic teeth with apical periodontitis: a randomized clinical trial. J Endod. 2007 Oct;33(10):1145-8. doi: 10.1016/j.joen.2007.07.005.

  PMID: 17889679 RESULT

• Moller AJ, Fabricius L, Dahlen G, Ohman AE, Heyden G. Influence on periapical tissues of indigenous oral bacteria and necrotic pulp tissue in monkeys. Scand J Dent Res. 1981 Dec;89(6):475-84. doi: 10.1111/j.1600-0722.1981.tb01711.x.

  PMID: 6951246 RESULT

• Peters LB, Wesselink PR. Periapical healing of endodontically treated teeth in one and two visits obturated in the presence or absence of detectable microorganisms. Int Endod J. 2002 Aug;35(8):660-7. doi: 10.1046/j.1365-2591.2002.00541.x.

  PMID: 12196219 RESULT

• Siqueira JF Jr, Rocas IN, Favieri A, Lima KC. Chemomechanical reduction of the bacterial population in the root canal after instrumentation and irrigation with 1%, 2.5%, and 5.25% sodium hypochlorite. J Endod. 2000 Jun;26(6):331-4. doi: 10.1097/00004770-200006000-00006.

  PMID: 11199749 RESULT

• Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.

  PMID: 9477818 RESULT

• Spangberg L, Engstrom B, Langeland K. Biologic effects of dental materials. 3. Toxicity and antimicrobial effect of endodontic antiseptics in vitro. Oral Surg Oral Med Oral Pathol. 1973 Dec;36(6):856-71. doi: 10.1016/0030-4220(73)90338-1. No abstract available.

  PMID: 4208832 RESULT

• Yesilsoy C, Whitaker E, Cleveland D, Phillips E, Trope M. Antimicrobial and toxic effects of established and potential root canal irrigants. J Endod. 1995 Oct;21(10):513-5. doi: 10.1016/s0099-2399(06)80524-8.

  PMID: 8596073 RESULT

MeSH Terms

Conditions

Pulpitis; Periapical Periodontitis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Thomas Kvist, phD

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 12, 2016
• Study Start: October 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)