C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection

December 22, 2020 updated by: Dr.Joyson Joe Asir.J, CSI College of Dental Sciences and Research, Madurai

Assessment of C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection

C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In patients with acute apical abscess C-reactive proteins are evaluated before and after root canal treatment. In this intra-canal medications calcium hydroxide and triple antibiotic paste are compared. PAI score of the corresponding tooth is noted .

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil NADU
      • Madurai, Tamil NADU, India, 625001
        • Recruiting
        • CSI College of Dental Sciences and Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

patient with acute apical abscess

Exclusion Criteria:

  • Teeth with evidence of previous initiated root canal treatment
  • History of myocardial infarction, coronary heart disease
  • Patients allergic to local anesthetic
  • Patients under steroid medication
  • Patients who are immunocompromised

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: calcium hydroxide
calcium hydroxide powder is mixed with normal saline and placed as intra-canal medication
Procedure: ROOT CANAL TREATMENT
TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT
EXPERIMENTAL: Triple antibiotic paste

Triple antibiotic paste (TAP)- combination of metronidazole,ciprofloxacin and minocycline mixed in a ratio of 1:1:1 .

TAP paste is combined with propylene glycol and placed as intra canal medication.
Procedure: ROOT CANAL TREATMENT
TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post root canal C reactive protein level
Time Frame: 2 weeks

Pre-operative serum c-reactive protein level was measured to which the post operative c-reactive protein level after 2 weeks of root canal treatment are compared.

The normal serum c-reactive protein level is 0 - 6.00 mg/L.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain and swelling assessment
Time Frame: 6 months
pain and swelling reduction after root canal treatment is assessed. . Pain is evaluated using visual analgue scale (VAS) , regarding swellling reduction patient is asked to evaluate subjectively whether the patient profile has returned to normal after the treatment and they were asked how many days it took for the swelling to resolve completely.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSI College of Dental Sciences and Research, Madurai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSIDentalCMadurai

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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