Back to resultsC-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
Primary Purpose
Dentoalveolar Abscess
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ROOT CANAL TREATMENT
Sponsored by
About this trial
This is an interventional diagnostic trial for Dentoalveolar Abscess
Eligibility Criteria
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
Sites / Locations
- Csi College of Dental Sciences and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
calcium hydroxide
Triple antibiotic paste
Arm Description
calcium hydroxide powder is mixed with normal saline and placed as intra-canal medication
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.
Outcomes
Primary Outcome Measures
Post root canal C reactive protein level
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.
Secondary Outcome Measures
pain and swelling assessment
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.
Full Information
NCT ID
NCT04684407
First Posted
December 15, 2020
Last Updated
December 22, 2020
Sponsor
CSI College of Dental Sciences and Research, Madurai
1. Study Identification
Unique Protocol Identification Number
NCT04684407
Brief Title
C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
Official Title
Assessment of C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CSI College of Dental Sciences and Research, Madurai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
C-reactive protein levels of patients with acute apical abscess are evaluated before and after root canal 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentoalveolar Abscess
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
calcium hydroxide
Arm Type
Active Comparator
Arm Description
calcium hydroxide powder is mixed with normal saline and placed as intra-canal medication
Arm Title
Triple antibiotic paste
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ROOT CANAL TREATMENT
Intervention Description
TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT
Primary Outcome Measure Information:
Title
Post root canal C reactive protein level
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
pain and swelling assessment
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Csi College of Dental Sciences and Research
City
Madurai
State/Province
Tamil NADU
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOYSON JOE ASIR J, MDS III YR
Phone
09488986939
Email
joysonjoe10@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
C-reactive Protein Levels in Acute Apical Abscess Due to Root Canal Infection
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