NCT04684407

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

December 15, 2020

Last Update Submit

December 22, 2020

Conditions

Dentoalveolar Abscess

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (1)

  • pain and swelling assessment

    6 months

Study Arms (2)

calcium hydroxide

ACTIVE COMPARATOR

calcium hydroxide powder is mixed with normal saline and placed as intra-canal medication

Procedure: ROOT CANAL TREATMENT

Triple antibiotic paste

EXPERIMENTAL

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

Interventions

ROOT CANAL TREATMENTPROCEDURE

TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT

Triple antibiotic pastecalcium hydroxide

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient with acute apical abscess

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Csi College of Dental Sciences and Research

Madurai, Tamil Nadu, 625001, India

RECRUITING

MeSH Terms

Conditions

Periapical Abscess

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 24, 2020

Study Start

November 1, 2020

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

December 24, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)