Postoperative PainNCT05051410
Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems
A study testing intracanal cryotherapy using needle irrigation and EndoVac system in people with Postoperative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
this study was conducted to know the effect of intracanal cryotherapy on postoperative pain using two different irrigation systems to deliver the cold saline. method: A total of 75 patients presenting with a diagnosis of irreversible pulpitis with symptomatic apical periodontitis in single rooted teeth were included… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- intracanal cryotherapy using needle irrigation and EndoVac system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2019to 30 Mar 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years.
- No significant present and past medical findings.
- Mature, single rooted teeth with single canal and closed apices.
- Symptomatic irreversible pulpitis with symptomatic apical periodontitis (moderate to severe pain according to VAS).
- Periodontal status- healthy periodontium according to Classification of Periodontal Disease and Conditions. (i.e. code 0).
Who cannot join
- Immature teeth with open apices.
- Root presenting with resorption, fracture, root caries, root curvature ≥ 10°.
- Calcified canals.
- Pregnancy.
- systemic disorders and taking medications
- Perio - endo lesion
Trial locations and contacts
1 site in 1 country.
About this study
this study was conducted to know the effect of intracanal cryotherapy on postoperative pain using two different irrigation systems to deliver the cold saline.
method: A total of 75 patients presenting with a diagnosis of irreversible pulpitis with symptomatic apical periodontitis in single rooted teeth were included in the study and randomly divided into three groups (n=25) (i.e. Control group, cryotherapy group with needle irrigation and cryotherapy group with negative pressure irrigation system). After complete root canal cleaning and shaping, final irrigation was done with 2.5°c 0.9% physiological saline in cryotherapy groups with needle irrigation (NI) and negative pressure irrigation system (NPI) whereas in control group no additional irrigation was done. Root canal treatment was completed in single visit. Participants were asked through telephone to rate their postoperative pain intensity after root canal treatment by visual analogue scale from day 1 till day 7 on given proforma.
two way repeated measures of ANOVA test were applied to know the mean difference between and among the groups.
Read the detailed description
Intracanal cryotherapy is one of the methods recently used to reduce the postoperative pain. The aim of this randomized control trial was to evaluate the effect of cold saline (cryotherapy) as a final irrigant on postoperative pain with two different irrigation systems after single visit root canal treatment objective: To find out the effect of cryotherapy as a final irrigant after root canal preparation on postoperative pain using needle irrigation and negative pressure irrigation system (EndoVac).
method: the intervention used in this study was intracanal cryotherapy with two different irrigation systems i.e. needle irrigation and negative pressure irrigation system(EndoVac). for cryotherapy cold saline was used at temperature of 2.5 °c. total sample size was calculated was 75 by using PASS version 11.non probability purposive sampling was used for patient recruitment. three groups were made with sample size of 25 in each group. group allocation was done by computer generated random numbers.according to inclusion and exclusion criteria patients were selected and after complete diagnosis patients were thoroughly explained about the treatment and informed consent were taken. to record the preoperative pain ,patients were provided a proforma. proforma consisted of visual analogue scale for pain record. endodontic procedure was performed by the principal investigator and it was same in all the three groups.final irrigation protocol was diferent among the groups; control group:no final irrigation was done, cryotherapy with needle irrigation: with needle irrigation cold saline was delivered,cryotherapy with EndoVac: with EndoVac cold saline was delivered. obturation in root canal was done with same protocol in all the groups.and access cavity was filled with temporary restoration. postoperative instruction was given to the patient and follow up procedure has also been explained to them. follow up was consisted of 7 days and through phone call by assessor which was blind regarding the groups. at day 7, patient were returned with proforma in which they have noted the pain score of 7 days and at the same visit temporary filling was replaced by permanent one. the principal investigator was blind regarding the postoperative pain,as it was done by some other assessor.
statistical analysis was done by using SPSS v.16.the two-way ANOVA repeated measures was performed for mean comparision among and between the groups.chi-square/fischer exact test test was performed for analgesic intake.
- Conditions
- Postoperative Pain
- Being tested
- intracanal cryotherapy using needle irrigation and EndoVac system
- Keywords
- cryotherapy, postoperative pain, single visit, negative pressure irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracanal cryotherapy using needle irrigation and EndoVac systemProcedure or surgery
a cold saline will be used as final irrigant in two groups but with different irrigation systems.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | single visit root canal treatment will be performed with no additional irrigation. |
| intracanal cryotherapy with needle irrigation | Experimental | single visit root canal treatment will be performed with additional irrigation with cold saline using needle irrigation. Receives: Procedure: intracanal cryotherapy using needle irrigation and EndoVac system |
| intracanal cryotherapy using Endovac system | Experimental | single visit root canal treatment will be performed with additional irrigation with cold saline using EndoVac system. Receives: Procedure: intracanal cryotherapy using needle irrigation and EndoVac system |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperavtive pain after intracanal crytherapy using two different irrigation systems
visual analogue scale (VAS) was used to assess postoperative pain after the treatment.Proforma was provided to the patient which include VAS. The scale is usually a 10 cm line with clearly defined boundaries. 0= no pain,1-3=mild pain,4-6=moderate pain and 7-10=severe pain.patient marked the number according to their pain level..
Measured: post operative pain was assessed for 7 days after treatment,visual analogue scale was used to assess the pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Jul 2019
- Primary completion18 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subject are randomly placed into one of the three groups:control,intracanal cryotherapy with needle irrigation, intracanal cryotherapy with EndoVac system. cold saline will be used in intracanal cryotherapy for five minutes. postoperative pain will be evaluated for 7 days using visual analogue scale.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Rafique, Dow University of Health Sciences
- Investigators
- Maryam rafique, MDS, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051410
- Sponsor's protocol ID
- MRafique
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracanal Cryotherapy on Postoperative Pain Using Two Different Irrigation Systems
- ClinicalTrials.gov ID
- NCT05051410
- Acronym / sponsor ID
- MRafique
- Conditions
- Postoperative Pain
- Keywords
- cryotherapy, postoperative pain, single visit, negative pressure irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 21 Sep 2021 (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.
this study was conducted to know the effect of intracanal cryotherapy on postoperative pain using two different irrigation systems to deliver the cold saline.
method: A total of 75 patients presenting with a diagnosis of irreversible pulpitis with symptomatic apical periodontitis in single rooted teeth were included in the study and randomly divided into three groups (n=25) (i.e. Control group, cryotherapy group with needle irrigation and cryotherapy group with negative pressure irrigation system). After complete root canal cleaning and shaping, final irrigation was done with 2.5°c 0.9% physiological saline in cryotherapy groups with needle irrigation (NI) and negative pressure irrigation system (NPI) whereas in control group no additional irrigation was done. Root canal treatment was completed in single visit. Participants were asked through telephone to rate their postoperative pain intensity after root canal treatment by visual analogue scale from day 1 till day 7 on given proforma.
two way repeated measures of ANOVA test were applied to know the mean difference between and among the groups.
Detailed description
Intracanal cryotherapy is one of the methods recently used to reduce the postoperative pain. The aim of this randomized control trial was to evaluate the effect of cold saline (cryotherapy) as a final irrigant on postoperative pain with two different irrigation systems after single visit root canal treatment objective: To find out the effect of cryotherapy as a final irrigant after root canal preparation on postoperative pain using needle irrigation and negative pressure irrigation system (EndoVac).
method: the intervention used in this study was intracanal cryotherapy with two different irrigation systems i.e. needle irrigation and negative pressure irrigation system(EndoVac). for cryotherapy cold saline was used at temperature of 2.5 °c. total sample size was calculated was 75 by using PASS version 11.non probability purposive sampling was used for patient recruitment. three groups were made with sample size of 25 in each group. group allocation was done by computer generated random numbers.according to inclusion and exclusion criteria patients were selected and after complete diagnosis patients were thoroughly explained about the treatment and informed consent were taken. to record the preoperative pain ,patients were provided a proforma. proforma consisted of visual analogue scale for pain record. endodontic procedure was performed by the principal investigator and it was same in all the three groups.final irrigation protocol was diferent among the groups; control group:no final irrigation was done, cryotherapy with needle irrigation: with needle irrigation cold saline was delivered,cryotherapy with EndoVac: with EndoVac cold saline was delivered. obturation in root canal was done with same protocol in all the groups.and access cavity was filled with temporary restoration. postoperative instruction was given to the patient and follow up procedure has also been explained to them. follow up was consisted of 7 days and through phone call by assessor which was blind regarding the groups. at day 7, patient were returned with proforma in which they have noted the pain score of 7 days and at the same visit temporary filling was replaced by permanent one. the principal investigator was blind regarding the postoperative pain,as it was done by some other assessor.
statistical analysis was done by using SPSS v.16.the two-way ANOVA repeated measures was performed for mean comparision among and between the groups.chi-square/fischer exact test test was performed for analgesic intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- subject are randomly placed into one of the three groups:control,intracanal cryotherapy with needle irrigation, intracanal cryotherapy with EndoVac system. cold saline will be used in intracanal cryotherapy for five minutes. postoperative pain will be evaluated for 7 days using visual analogue scale.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –single visit root canal treatment will be performed with no additional irrigation. |
| intracanal cryotherapy with needle irrigation | Experimental | Procedure: intracanal cryotherapy using needle irrigation and EndoVac systemsingle visit root canal treatment will be performed with additional irrigation with cold saline using needle irrigation. |
| intracanal cryotherapy using Endovac system | Experimental | Procedure: intracanal cryotherapy using needle irrigation and EndoVac systemsingle visit root canal treatment will be performed with additional irrigation with cold saline using EndoVac system. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years.
- No significant present and past medical findings.
- Mature, single rooted teeth with single canal and closed apices.
- Symptomatic irreversible pulpitis with symptomatic apical periodontitis (moderate to severe pain according to VAS).
- Periodontal status- healthy periodontium according to Classification of Periodontal Disease and Conditions. (i.e. code 0).
Key exclusion criteria (6 listed)
- Immature teeth with open apices.
- Root presenting with resorption, fracture, root caries, root curvature ≥ 10°.
- Calcified canals.
- Pregnancy.
- systemic disorders and taking medications
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 |
|---|---|---|
| intracanal cryotherapy using needle irrigation and EndoVac systema cold saline will be used as final irrigant in two groups but with different irrigation systems. | Procedure or surgery | intracanal cryotherapy using Endovac system, intracanal cryotherapy with needle irrigation |
Primary outcome
incidence of postoperavtive pain after intracanal crytherapy using two different irrigation systems
Time frame: post operative pain was assessed for 7 days after treatment,visual analogue scale was used to assess the pain
visual analogue scale (VAS) was used to assess postoperative pain after the treatment.Proforma was provided to the patient which include VAS. The scale is usually a 10 cm line with clearly defined boundaries. 0= no pain,1-3=mild pain,4-6=moderate pain and 7-10=severe pain.patient marked the number according to their pain level..
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 21 Sep 2021.
- 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.
Maryam rafique, MDS principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracanal cryotherapy using needle irrigation and EndoVac system in people with Postoperative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
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 6 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 21 Sep 2021. 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 Pakistan. 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?
incidence of postoperavtive pain after intracanal crytherapy using two different irrigation systems (time frame: post operative pain was assessed for 7 days after treatment,visual analogue scale was used to assess the pain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.