NCT03044470

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

February 1, 2017

Last Update Submit

February 2, 2017

Conditions

Effects of; Cold

Outcome Measures

Primary Outcomes (1)

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

    12,24,48,72 hours

Study Arms (2)

Cold saline

EXPERIMENTAL

Saline stored at 4 degrees centigrade

Other: cryotherapy

Normal Saline

EXPERIMENTAL

Saline stored at room temperature

Other: cryotherapy

Interventions

cryotherapyOTHER

Role of cryotherapy in reduction of post operative pain

Also known as: Cold saline
Cold salineNormal Saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mamata Dental College

Khammam, Telangana, 507002, India

Location

MeSH Terms

Conditions

Common Cold

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
POST GRADUATE

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 7, 2017

Study Start

June 1, 2016

Primary Completion

August 31, 2016

Study Completion

September 5, 2016

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

IN(1)