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CompletedNCT03044470Updated Feb 7, 2017

Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy

An interventional study of cryotherapy in Effects of; Cold, sponsored by Mamata Dental College. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Mamata Dental College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Effects of; Cold

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03

In context

Common Cold

184 studies on the registry are indexed under Common Cold; 21 are open to participants now.

This study's enrollment of 40 is below the median of 161 across 155 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

This is the only study on the registry with Mamata Dental College as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Above 18 years of age
  • Healthy patients without any medical conditions

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cold saline

    Saline stored at 4 degrees centigrade

    Other: cryotherapy

  • Experimental
    Normal Saline

    Saline stored at room temperature

    Other: cryotherapy

Interventions

  • Othercryotherapy

    Role of cryotherapy in reduction of post operative pain

    Also known as: Cold saline

06

What researchers measure

Primary outcomes

  1. Post endodontic pain measure at different time intervals using heft parker visual analog scale

    Time frame: 12,24,48,72 hours

07

Study locations

1 site
  • Mamata Dental College
    Khammam, Telangana 507002, India
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Aug 2016, 2 months.

Of 39 interventional studies with no phase under Common Cold, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2017
First posted
Feb 7, 2017
StartActual
Jun 1, 2016
Primary completionActual
Aug 31, 2016
CompletionActual
Sep 5, 2016
Last update
Feb 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03044470
Lead sponsor
Mamata Dental College
Responsible party
KIRIT GOLLA (POST GRADUATE, Mamata Dental College) — Principal investigator
First posted
Feb 7, 2017
Start date
Jun 1, 2016
Primary completion
Aug 31, 2016
Completion
Sep 5, 2016
Last update
Feb 7, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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