Effects of; ColdNCT03044470
Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
A study testing cryotherapy in people with Effects of; Cold, run by Mamata Dental College at 1 site in India.
Trial summary
AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy. METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of; Cold
- What is being tested?
- cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2016to 5 Sep 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Healthy patients without any medical conditions
Who cannot join
- root canal retreatment
- pregnancy
- teeth with open apices
- a history of intolerance to nonsteroidal anti-inflammatory drugs
- immunosuppressed patients
- those under 18 years old
- patients requiring antibiotic prophylaxis
- patients with pacemakers.
Trial locations and contacts
1 site in 1 country.
About this study
AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy.
METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.
- Conditions
- Effects of; Cold
- Being tested
- cryotherapy
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
Also called Cold saline
Role of cryotherapy in reduction of post operative pain
| Study group | Role | What they receive |
|---|---|---|
| Cold saline | Experimental | Saline stored at 4 degrees centigrade Receives: Other: cryotherapy |
| Normal Saline | Experimental | Saline stored at room temperature Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post endodontic pain measure at different time intervals using heft parker visual analog scale
Measured: 12,24,48,72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jun 2016
- Primary completion31 Aug 2016
- Study completion5 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; ColdStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mamata Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KIRIT GOLLA, Mamata Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044470
- Sponsor's protocol ID
- Mamata DC
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
- ClinicalTrials.gov ID
- NCT03044470
- Acronym / sponsor ID
- Mamata DC
- Conditions
- Effects of; Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mamata Dental CollegeUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 5 Sep 2016 (actual)
- First posted
- 7 Feb 2017 (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 determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy.
METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold saline | Experimental | Other: cryotherapySaline stored at 4 degrees centigrade |
| Normal Saline | Experimental | Other: cryotherapySaline stored at room temperature |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years of age
- Healthy patients without any medical conditions
Key exclusion criteria (8 listed)
- root canal retreatment
- pregnancy
- teeth with open apices
- a history of intolerance to nonsteroidal anti-inflammatory drugs
- immunosuppressed patients
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 |
|---|---|---|
| cryotherapyAlso: Cold salineRole of cryotherapy in reduction of post operative pain | Other | Cold saline, Normal Saline |
Primary outcome
Post endodontic pain measure at different time intervals using heft parker visual analog scale
Time frame: 12,24,48,72 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 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Effects of; Cold, run by Mamata Dental College at 1 site in India.
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 8 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 7 Feb 2017. 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 India. 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?
Post endodontic pain measure at different time intervals using heft parker visual analog scale (time frame: 12,24,48,72 hours). 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 7 Feb 2017.