PulpitisNCT02681276
Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment
A study testing Irrigation with 3% NaOCl and Irrigation with 0.5% NaOCl in people with Pulpitis and Apical Periodontitis, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Apical Periodontitis
- What is being tested?
- Irrigation with 3% NaOCl and Irrigation with 0.5% NaOCl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patient does not understand Swedish
- the tooth will be treated with a retrograde approach
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The aim of the present study is to compare the antimicrobial and immediate clinical effect of NaOCl 0.5% with the effect of NaOCl 3% in the endodontic treatment of teeth referred to the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland. The efficiency of the treatment will be evaluated with sampling and cultivation methods and the assessment of patients' symptoms with a visual analogue scale.
The sample size calculation was performed with a type I error of 0.05 and statistical power of 80 %. The investigators expected 70 % of the samples to be free from bacteria growth in the control group and the investigators considered clinically relevant a difference of 15 % between the groups in order to demonstrate significant differences attributable to the experimental therapy used. The investigators want our sample size to be two hundred sixty four patients, 132 to each group.
A detailed explanation of the purpose of the study was given. Patients were also informed about the confidentiality of the data to be collected and about the voluntary participation. Every patient gets assigned a code that indicates which group they belong so the same irrigant is used in case of more than one visit.
Root canal treatment followed the standard principles of the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland but the treatments were not restricted to a single protocol.
The recommended minimum or optimal apical size of canal preparation is size 25. All the operators are informed to perform the endodontic treatment the way operators normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal. One group was irrigated with Sodium Hypochlorite 0.5 % (Dakin's solution) and the other group with Sodium Hypochlorite 3 %.
Operators were free to choose any additional irrigant as clinically perceived necessary. The irrigants available at the clinic were 17% ethylene-diamine-tetra-acetic acid (EDTA) and iodine-potassium-iodide (IPI) 5% used as a short duration antimicrobial agent as intracanal medication for 10 minutes.
Canal irrigation was carried out using 27 gauge side-cut open end needles (Monoject Luer lock syringe) with supplementation by ultrasonic agitation. Calcium hydroxide was the standard inter-appointment medicament. After sampling procedures gutta-percha and AH-plus sealer were used for root filling.
The access cavity was filled with Intermediate Restorative Material (IRM) or a permanent filling with composite after each appointment and after finished root canal treatment.
After bacterial sampling of the root canal, the samples were processed at the laboratory as outlined by Möller. Anaerobic incubation was done in a semi liquid medium (Hunton medium) inoculated under flow of oxygen-free gas. The mediums are checked daily for 14 days or until there is signs of microbial growth.
Fischer's exact test will be used for comparisons between groups regarding growth / no growth. For assessments of pain on the VAS t-test and 95% confidence intervals will be used. All hypothesis tests will be conducted at the 0.05 level of significance.
The outcomes will be analysed in term of positive Cultures and post operative pain. This is discussed further elsewhere in this application.
- Conditions
- Pulpitis, Apical Periodontitis
- Being tested
- Irrigation with 3% NaOCl, Irrigation with 0.5% NaOCl
- Keywords
- Irrigation during root canal treatment, Sodium Hypochlorite
- Medical subject headings
- Pulpitis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation with 3% NaOClProcedure or surgery
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% NaOClProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 %. Receives: 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 %. Receives: Procedure: Irrigation with 0.5% NaOCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Each patient was instructed to fill in a questionnaire after each visit. This questionnaire contains seven visual scales (VAS) based on a 10 cm line determining the pain level. The patient is asked to estimate the pain they have 7 days after the endodontic procedure where 1 is very mild pain and 10 the worse pain they can imagine. The questionnaires were measured with a plastic ruler and the recordings will be transposed to numbers and registered in the excel file by the main investigator.
Measured: 7 consecutive days after each appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kvist, Göteborg University
- Investigators
- Thomas Kvist, phD, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681276
- Sponsor's protocol ID
- Irrigation 3% NaOCl
- Status last verified
- Aug 2018
- First submitted
- 26 Jan 2016
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data is going to be published at a Group level
Publications
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.
PubMed 17496870Ayhan 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.
PubMed 10371903Baumgartner 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.
PubMed 1298800Bystrom 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.
PubMed 3922900Fabricius 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.
PubMed 16911098Hand 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.
PubMed 277629Harrison 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.
PubMed 6783724KAKEHASHI 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.
PubMed 14342926Molander 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.
PubMed 17889679Moller 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.
PubMed 6951246Peters 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.
PubMed 12196219Siqueira 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.
PubMed 11199749Sjogren 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.
PubMed 9477818Spangberg 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.
PubMed 4208832Yesilsoy 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.
PubMed 8596073
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment
- ClinicalTrials.gov ID
- NCT02681276
- Acronym / sponsor ID
- Irrigation 3% NaOCl
- Conditions
- Pulpitis, Apical Periodontitis
- Keywords
- Irrigation during root canal treatment, Sodium Hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the present study is to compare the antimicrobial and immediate clinical effect of NaOCl 0.5% with the effect of NaOCl 3% in the endodontic treatment of teeth referred to the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland. The efficiency of the treatment will be evaluated with sampling and cultivation methods and the assessment of patients' symptoms with a visual analogue scale.
The sample size calculation was performed with a type I error of 0.05 and statistical power of 80 %. The investigators expected 70 % of the samples to be free from bacteria growth in the control group and the investigators considered clinically relevant a difference of 15 % between the groups in order to demonstrate significant differences attributable to the experimental therapy used. The investigators want our sample size to be two hundred sixty four patients, 132 to each group.
A detailed explanation of the purpose of the study was given. Patients were also informed about the confidentiality of the data to be collected and about the voluntary participation. Every patient gets assigned a code that indicates which group they belong so the same irrigant is used in case of more than one visit.
Root canal treatment followed the standard principles of the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland but the treatments were not restricted to a single protocol.
The recommended minimum or optimal apical size of canal preparation is size 25. All the operators are informed to perform the endodontic treatment the way operators normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal. One group was irrigated with Sodium Hypochlorite 0.5 % (Dakin's solution) and the other group with Sodium Hypochlorite 3 %.
Operators were free to choose any additional irrigant as clinically perceived necessary. The irrigants available at the clinic were 17% ethylene-diamine-tetra-acetic acid (EDTA) and iodine-potassium-iodide (IPI) 5% used as a short duration antimicrobial agent as intracanal medication for 10 minutes.
Canal irrigation was carried out using 27 gauge side-cut open end needles (Monoject Luer lock syringe) with supplementation by ultrasonic agitation. Calcium hydroxide was the standard inter-appointment medicament. After sampling procedures gutta-percha and AH-plus sealer were used for root filling.
The access cavity was filled with Intermediate Restorative Material (IRM) or a permanent filling with composite after each appointment and after finished root canal treatment.
After bacterial sampling of the root canal, the samples were processed at the laboratory as outlined by Möller. Anaerobic incubation was done in a semi liquid medium (Hunton medium) inoculated under flow of oxygen-free gas. The mediums are checked daily for 14 days or until there is signs of microbial growth.
Fischer's exact test will be used for comparisons between groups regarding growth / no growth. For assessments of pain on the VAS t-test and 95% confidence intervals will be used. All hypothesis tests will be conducted at the 0.05 level of significance.
The outcomes will be analysed in term of positive Cultures and post operative pain. This is discussed further elsewhere in this application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation with 3% NaOCl | Experimental | Procedure: Irrigation with 3% NaOClAfter 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 %. |
| Irrigation with 0.5% NaOCl | Active comparator | Procedure: Irrigation with 0.5% NaOClAfter 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 %. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- patient does not understand Swedish
- the tooth will be treated with a retrograde approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation with 3% NaOClAll 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. | Procedure or surgery | Irrigation with 3% NaOCl |
| Irrigation with 0.5% NaOClAll 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. | Procedure or surgery | Irrigation with 0.5% NaOCl |
Primary outcome
Assessing bacterial growth in the root canal (positive meaning cultivable bacteria present, negative meaning absence of cultivable bacteria)
Time frame: Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken.
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.
1 secondary outcome
Assessment of post-operative pain using a questionnaire containing 7 visual scales.
Time frame: 7 consecutive days after each appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Background: PubMed 17496870Spencer 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.
- Results publication: PubMed 10371903Ayhan 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.
- Results publication: PubMed 1298800Baumgartner 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.
- Results publication: PubMed 3922900Bystrom 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.
- Results publication: PubMed 16911098Fabricius 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.
- Results publication: PubMed 277629Hand 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.
- Results publication: PubMed 6783724Harrison 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.
- Results publication: PubMed 14342926KAKEHASHI 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.
- Results publication: PubMed 17889679Molander 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.
- Results publication: PubMed 6951246Moller 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.
- Results publication: PubMed 12196219Peters 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.
- Results publication: PubMed 11199749Siqueira 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.
- Individual participant dataSharing planned: No. The data is going to be published at a Group level
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kvist, phD study chair
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation with 3% NaOCl and Irrigation with 0.5% NaOCl in people with Pulpitis and Apical Periodontitis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing bacterial growth in the root canal (positive meaning cultivable bacteria present, negative meaning absence of cultivable bacteria) (time frame: Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681276, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.