Postoperative PainNCT04190355
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
A study testing Irrigant type, 5.25% NaOCl and 5.25% Cloraxid gel/ distilled water in people with Postoperative Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Chemomechanical preparation of the root canal system potentially results in extrusion of debris into the periradicular tissues. This debris is composed of hard tissue (dentin), soft tissue (inflamed or necrotic pulp tissues) and microbiota. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Irrigant type, 5.25% NaOCl and 5.25% Cloraxid gel/ distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2019to 30 Dec 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain: a Randomized Controlled Clinical Trial
Chemomechanical preparation of the root canal system potentially results in extrusion of debris into the periradicular tissues. This debris is composed of hard tissue (dentin), soft tissue (inflamed or necrotic pulp tissues) and microbiota. Furthermore, the chemical adjuncts used during root canal disinfection may also extrude into the periradicular tissues. Extrusion of such materials results in postoperative pain, inflammation and and flare-up. There is evidence to demonstrate that most instrumentation techniques cause extrusion of debris, and that, severity of the inflammatory response depends on the amount of debris extrusion. Several factors may influence the debris extrusion during root canal preparation, including the instrument design, technique of use and irrigating agent used during preparation.Sodium hypochlorite (NaOCl) is the most commonly used root canal irrigant during root canal treatment. However, its cytotoxic effects when extruded into the periapical tissues is an issue of clinical concern. Thus, there has been a search for more biocompatible irrigants. One potential option, which has not been explored in detail, is the use of NaOCl, but in a gel form rather than a solution. NaOCl gel has similar effects on the dentin, as the solution form. Interestingly, greater dentinal tubule penetration depth has been reported for the gel form, compared to the solution. Previous studies have evaluated the effect of preparation techniques, the number of appointments and intracranial medicaments on postoperative pain during Endodontics treatment. There is no study evaluating the effect of different irritant type on PP. Therefore, this study will be evaluated the effect of different irritant type (gel or solution form of NaOCI) on postoperative pain.
Read the detailed description
- The study is planned to be performed on 104 patients who are aged between 18-45 years and who have no systemic disease and are diagnosed and followed up in Yüzüncü Yıl University Faculty of Dentistry, Department of Endodontics.
- Patients who have been diagnosed with irreversible pulpitis will be included in the study group.
- Patients with periapical lesions and incomplete apex development will not be included in the study group.
- The access cavity will be prepared under local anesthesia.Working length of the canal will be determined as it ends in apical constriction, by using 15 k file with apex locater and periapical radiographs.
- Preperation of root canals will be finished with ProTaperNext X3 instrument as standard and applied to each patient.
- All patients will be randomly divided into two groups according to the irrigation protocol (G1: 5.25% NaOCI; G2: Chloraxid gel / distilled water) (n = 250).
- Group 1: 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 1: 2 ml of 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation. The tip of the cannula will be adjusted to reach two-thirds of the working length.
- Final irrigation procedure after canal preperation, 5 ml of 5.25% NaOCl solution, 5 ml of 17% EDTA solution, 5.25% NaOCl solution will be used respectively for both groups as standard.
- After the final irrigation process, the root canals will be dried with sterile paper points, then they will be filled with sterile gutta-percha with lateral condensation technique by hand spredars. After root canal filling teeth will be restorated for coronal sealing.
- After the treatment, the patients in both groups will be asked to report the pain levels at certain intervals (6th hour-24th hour-48th hour-72th hour-1st week) according to the VAS scale.
- According to the questionnaires collected with patient feedbacks, the data will be analyzed and interpreted with statistical analysis ** (manwithney u-kruskall Wallis) in order to evaluate the pain levels after single visit root canal treatment.
- Conditions
- Postoperative Pain
- Being tested
- Irrigant type, 5.25% NaOCl, 5.25% Cloraxid gel/ distilled water
- Keywords
- Root canal, irrigation, irrigant type, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigant typeOther
The success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on postoperative pain using different uniforms will be evaluated.
5.25% NaOClDrug
5.25% NaOCl solution
5.25% Cloraxid gel/ distilled waterDrug
5.25% Cloraxid gel/ distilled water
| Study group | Role | What they receive |
|---|---|---|
| 5.25% NaOCl solution | Active comparator | 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation Receives: Other: Irrigant type; Drug: 5.25% NaOCl |
| 5.25% Cloraxid gel/ distilled water | Active comparator | 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation Receives: Drug: 5.25% Cloraxid gel/ distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scala
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start29 Sep 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 1: 2 ml of 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation. The tip of the cannula will be adjusted to reach two-thirds of the working length.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
- Investigators
- Esin Özlek, PhD, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190355
- Sponsor's protocol ID
- 11/29.05.2019
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Different Irrigation Agitation Techniques on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Oct;44(10):1451-1456. doi: 10.1016/j.joen.2018.06.008. Epub 2018 Aug 23.
PubMed 30144989
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04190355
- Acronym / sponsor ID
- 11/29.05.2019
- Conditions
- Postoperative Pain
- Keywords
- Root canal, irrigation, irrigant type, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 9 Dec 2019 (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.
Chemomechanical preparation of the root canal system potentially results in extrusion of debris into the periradicular tissues. This debris is composed of hard tissue (dentin), soft tissue (inflamed or necrotic pulp tissues) and microbiota. Furthermore, the chemical adjuncts used during root canal disinfection may also extrude into the periradicular tissues. Extrusion of such materials results in postoperative pain, inflammation and and flare-up. There is evidence to demonstrate that most instrumentation techniques cause extrusion of debris, and that, severity of the inflammatory response depends on the amount of debris extrusion. Several factors may influence the debris extrusion during root canal preparation, including the instrument design, technique of use and irrigating agent used during preparation.Sodium hypochlorite (NaOCl) is the most commonly used root canal irrigant during root canal treatment. However, its cytotoxic effects when extruded into the periapical tissues is an issue of clinical concern. Thus, there has been a search for more biocompatible irrigants. One potential option, which has not been explored in detail, is the use of NaOCl, but in a gel form rather than a solution. NaOCl gel has similar effects on the dentin, as the solution form. Interestingly, greater dentinal tubule penetration depth has been reported for the gel form, compared to the solution. Previous studies have evaluated the effect of preparation techniques, the number of appointments and intracranial medicaments on postoperative pain during Endodontics treatment. There is no study evaluating the effect of different irritant type on PP. Therefore, this study will be evaluated the effect of different irritant type (gel or solution form of NaOCI) on postoperative pain.
Detailed description
- The study is planned to be performed on 104 patients who are aged between 18-45 years and who have no systemic disease and are diagnosed and followed up in Yüzüncü Yıl University Faculty of Dentistry, Department of Endodontics.
- Patients who have been diagnosed with irreversible pulpitis will be included in the study group.
- Patients with periapical lesions and incomplete apex development will not be included in the study group.
- The access cavity will be prepared under local anesthesia.Working length of the canal will be determined as it ends in apical constriction, by using 15 k file with apex locater and periapical radiographs.
- Preperation of root canals will be finished with ProTaperNext X3 instrument as standard and applied to each patient.
- All patients will be randomly divided into two groups according to the irrigation protocol (G1: 5.25% NaOCI; G2: Chloraxid gel / distilled water) (n = 250).
- Group 1: 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 1: 2 ml of 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation. The tip of the cannula will be adjusted to reach two-thirds of the working length.
- Final irrigation procedure after canal preperation, 5 ml of 5.25% NaOCl solution, 5 ml of 17% EDTA solution, 5.25% NaOCl solution will be used respectively for both groups as standard.
- After the final irrigation process, the root canals will be dried with sterile paper points, then they will be filled with sterile gutta-percha with lateral condensation technique by hand spredars. After root canal filling teeth will be restorated for coronal sealing.
- After the treatment, the patients in both groups will be asked to report the pain levels at certain intervals (6th hour-24th hour-48th hour-72th hour-1st week) according to the VAS scale.
- According to the questionnaires collected with patient feedbacks, the data will be analyzed and interpreted with statistical analysis ** (manwithney u-kruskall Wallis) in order to evaluate the pain levels after single visit root canal treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 1: 2 ml of 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation. The tip of the cannula will be adjusted to reach two-thirds of the working length.
| Arm | Type | Receives |
|---|---|---|
| 5.25% NaOCl solution | Active comparator | Other: Irrigant type, Drug: 5.25% NaOCl5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation |
| 5.25% Cloraxid gel/ distilled water | Active comparator | Drug: 5.25% Cloraxid gel/ distilled water5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (7 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
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 |
|---|---|---|
| Irrigant typeThe success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on postoperative pain using different uniforms will be evaluated. | Other | 5.25% NaOCl solution |
| 5.25% NaOCl5.25% NaOCl solution | Drug | 5.25% NaOCl solution |
| 5.25% Cloraxid gel/ distilled water5.25% Cloraxid gel/ distilled water | Drug | 5.25% Cloraxid gel/ distilled water |
Primary outcome
VAS scala
Time frame: up to 7 days
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Results publication: PubMed 30144989Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Different Irrigation Agitation Techniques on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Oct;44(10):1451-1456. doi: 10.1016/j.joen.2018.06.008. Epub 2018 Aug 23.
- 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.
Esin Özlek, PhD study chair
Yuzuncu Yil 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 Irrigant type, 5.25% NaOCl and 5.25% Cloraxid gel/ distilled water in people with Postoperative Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Dec 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
VAS scala (time frame: up to 7 days). 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 NCT04190355, which also lists 1 linked publication.
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 9 Dec 2019.