Root Canal InfectionNCT03336970
Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment
A study testing EDTA, NaOCl and CHX in people with Root Canal Infection, run by Mehmet Kemal Çalışkan.
Trial summary
Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% CHX before obturation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- EDTA, NaOCl and CHX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Jun 2014
- 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 with a non-contributory medical history,
- mature maxillary anterior teeth with periapical lesions (< 5 mm),
- diagnosed as asymptomatic apical periodontitis.
Who cannot join
- clinical symptoms, drainage,
- more than 5 mm loss of periodontal attachment,
- previous endodontic treatment,
- non-restorable tooth.
About this study
Official title: Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment: A Prospective Comparative Study
Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in multiple visits (MV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 24 months.
Read the detailed description
The aim of the study was to evaluate postoperative pain and radiographic evidence of periapical healing in teeth with apical periodontitis treated in a single visit with an additional final irrigation using 2% chlorhexidine and to compare the results with conventional multiple-visit root canal treatment (RCT) with an intracanal calcium hydroxide dressing as a control group. Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated by a single operator using the step-back technique with manual instrumentation with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. The other teeth were treated in multiple visits (MV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 24 months. Postoperative pain at 24-48 hours and changes in apical bone density indicating radiographic healing were evaluated statistically using the Mann-Whitney U-test followed by the Friedman and the Wilcoxon tests (α=.05).
- Conditions
- Root Canal Infection
- Being tested
- EDTA, NaOCl, CHX, Calcium hydroxide
- Keywords
- single visit root canal treatment, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTAOther
NaOClOther
CHXOther
Calcium hydroxideOther
| Study group | Role | What they receive |
|---|---|---|
| Single visit root canal treatment | Active comparator | The teeth were treated in single-visit (SV) root canal treatment. Final root canal irrigation was performed with 5% EDTA, followed by 2.5% NaOCl and received an additional final rinse with 2% CHX before obturation. Receives: Other: EDTA; Other: NaOCl; Other: CHX |
| Multiple visit root canal treatment | Active comparator | The teeth were treated in multiple visit (MV) root canal treatment. After completion of root canal instrumentation, calcium hydroxide paste was placed into the root canal. In second visit, all root canals were irrigated with 5% EDTA followed by 2.5% NaOCl before obturation. Receives: Other: EDTA; Other: NaOCl; Other: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of radiographic healing of the periapical lesion
Follow-up visits were performed after 6, 12 and 24 months for all patients in order to evaluate radiographic status. Changes in apical bone density indicating radiographic healing was assessed by the periapical index (PAI).
Measured: 6,12 and 24 months
Secondary outcomes (1)
The level of postoperative pain
Postoperative pain after 24 and 48 hours, was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1 (no pain), 2 (mild pain), 3 (moderate pain/pain relieved by analgesics), to 4 (severe pain).
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jan 2011
- Primary completion1 Jan 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Kemal Çalışkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Kemal Çalışkan, Ege University
- Investigators
- Seniha Miçooğulları Kurt, Principal investigator, Ege University Faculty of DentistryMehmet Kemal Çalışkan, Study director, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336970
- Sponsor's protocol ID
- Single visit study
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
PubMed 22892729Penesis VA, Fitzgerald PI, Fayad MI, Wenckus CS, BeGole EA, Johnson BR. Outcome of one-visit and two-visit endodontic treatment of necrotic teeth with apical periodontitis: a randomized controlled trial with one-year evaluation. J Endod. 2008 Mar;34(3):251-7. doi: 10.1016/j.joen.2007.12.015.
PubMed 18291270El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
PubMed 20003932Zamany A, Safavi K, Spangberg LS. The effect of chlorhexidine as an endodontic disinfectant. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):578-81. doi: 10.1016/s1079-2104(03)00168-9.
PubMed 14600693Peters 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 12196219Rocas IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. doi: 10.1016/j.joen.2016.03.019. Epub 2016 Apr 30.
PubMed 27142579
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03336970
- Acronym / sponsor ID
- Single visit study
- Conditions
- Root Canal Infection
- Keywords
- single visit root canal treatment, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mehmet Kemal ÇalışkanUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in multiple visits (MV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 24 months.
Detailed description
The aim of the study was to evaluate postoperative pain and radiographic evidence of periapical healing in teeth with apical periodontitis treated in a single visit with an additional final irrigation using 2% chlorhexidine and to compare the results with conventional multiple-visit root canal treatment (RCT) with an intracanal calcium hydroxide dressing as a control group. Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated by a single operator using the step-back technique with manual instrumentation with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. The other teeth were treated in multiple visits (MV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 24 months. Postoperative pain at 24-48 hours and changes in apical bone density indicating radiographic healing were evaluated statistically using the Mann-Whitney U-test followed by the Friedman and the Wilcoxon tests (α=.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single visit root canal treatment | Active comparator | Other: EDTA, Other: NaOCl, Other: CHXThe teeth were treated in single-visit (SV) root canal treatment. Final root canal irrigation was performed with 5% EDTA, followed by 2.5% NaOCl and received an additional final rinse with 2% CHX before obturation. |
| Multiple visit root canal treatment | Active comparator | Other: EDTA, Other: NaOCl, Other: Calcium hydroxideThe teeth were treated in multiple visit (MV) root canal treatment. After completion of root canal instrumentation, calcium hydroxide paste was placed into the root canal. In second visit, all root canals were irrigated with 5% EDTA followed by 2.5% NaOCl before obturation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a non-contributory medical history,
- mature maxillary anterior teeth with periapical lesions (< 5 mm),
- diagnosed as asymptomatic apical periodontitis.
Key exclusion criteria (4 listed)
- clinical symptoms, drainage,
- more than 5 mm loss of periodontal attachment,
- previous endodontic treatment,
- non-restorable tooth.
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 |
|---|---|---|
| EDTA | Other | Multiple visit root canal treatment, Single visit root canal treatment |
| NaOCl | Other | Multiple visit root canal treatment, Single visit root canal treatment |
| CHX | Other | Single visit root canal treatment |
| Calcium hydroxide | Other | Multiple visit root canal treatment |
Primary outcome
The rate of radiographic healing of the periapical lesion
Time frame: 6,12 and 24 months
Follow-up visits were performed after 6, 12 and 24 months for all patients in order to evaluate radiographic status. Changes in apical bone density indicating radiographic healing was assessed by the periapical index (PAI).
1 secondary outcome
The level of postoperative pain
Time frame: 24 hours and 48 hours
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 8 Nov 2017.
- Background: PubMed 22892729Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
- Background: PubMed 18291270Penesis VA, Fitzgerald PI, Fayad MI, Wenckus CS, BeGole EA, Johnson BR. Outcome of one-visit and two-visit endodontic treatment of necrotic teeth with apical periodontitis: a randomized controlled trial with one-year evaluation. J Endod. 2008 Mar;34(3):251-7. doi: 10.1016/j.joen.2007.12.015.
- Background: PubMed 20003932El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
- Background: PubMed 14600693Zamany A, Safavi K, Spangberg LS. The effect of chlorhexidine as an endodontic disinfectant. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):578-81. doi: 10.1016/s1079-2104(03)00168-9.
- Background: 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.
- Background: PubMed 27142579Rocas IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. doi: 10.1016/j.joen.2016.03.019. Epub 2016 Apr 30.
- Individual participant dataSharing planned: No
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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.
Seniha Miçooğulları Kurt principal investigator
Ege University Faculty of Dentistry
Mehmet Kemal Çalışkan study director
Ege University Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing EDTA, NaOCl and CHX in people with Root Canal Infection, run by Mehmet Kemal Çalışkan.
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 3 inclusion and 4 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The rate of radiographic healing of the periapical lesion (time frame: 6,12 and 24 months). 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 NCT03336970, which also lists 6 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 8 Nov 2017.