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Clinical Trials/CTRI/2025/03/083089
CTRI/2025/03/083089Not yet recruitingNot Applicable

Comparative evaluation of antimicrobial efficacy of double antibiotic paste with distilled water double antibiotic paste with 2 percent chlorhexidine and bioceramic based intracanal medicament against e. Faecalis in primary teeth: a randomized controlled trial

DR SHWETA1 site in 1 country45 target enrollmentStarted: March 31, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
Difference in Microbial Count of E.Faecalis after access opening and after BMP

Study Overview

Brief Summary

AIM: TO COMPARE ANTIMICROBIAL EFFICACY OF DOUBLE ANTIBIOTIC PASTE WITH DISTILLED WATER, DOUBLE ANTIBIOTIC PASTE WITH 2% CHLORHEXIDINE SOLUTION, AND BIOCERAMIC BASED INTRACANAL MEDICAMENT AGAINST E. FAECALIS.

ROOT CANAL INFECTIONS IN PRIMARY TEETH OFTEN INVOLVE MIXED BACTERIA, WITH ENTEROCOCCUS FAECALIS BEING A COMMON PATHOGEN. ITS CAPABILITY TO ADHERE TO AND PENETRATE DENTIN, FORM BIOFILMS, AND TOLERATE HIGH PH VALUES MAKES IT RESISTANT TO MANY ANTIMICROBIALS. THOROUGH ERADICATION OF E. FAECALIS AND OTHER MICROORGANISMS DURING PULPECTOMY IS CRUCIAL TO PREVENT REINFECTION AND ENSURE SUCCESSFUL TREATMENT OUTCOMES.

IN OUR STUDY WE WILL BE COMPAIRING THE ANTIMICROBIAL EFFICACY OF BIOCERAMIC BASED INTRACANAL MEDICAMENT WITH DIFFERENT COMBINATIONS OF DOUBLE ANTIBIOTIC.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 11.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • It will be comprised of subjects whose parents will give the informed consent.
  • 1.Primary teeth with open carious lesions with exposure of pulp.
  • 2.Teeth with minimal periapical changes with sufficient bone support.
  • 4.At least 2/3rd of root length available.
  • 5.Subjects who had not taken any antibiotics in the last 3 months preceding the treatment will be incorporated in the study.

Exclusion Criteria

  • 1.Presence of signs such as prolonged or spontaneous pain, pathological mobility (Miller Grade II or more), sensitivity to percussion.
  • 2.The medically compromised patients and patients on antibiotics within three months will be excluded from the study.
  • 3.Non restorable tooth / Perforation of pulpal floor.
  • 4.Radiographic signs of internal/external root resorption.
  • 5.Previously endodontically treated teeth.
  • 6.Involvement of permanent tooth bud.
  • 7.Uncooperative children.

Outcomes

Primary Outcomes

Difference in Microbial Count of E.Faecalis after access opening and after BMP

Time Frame: Baseline, difference in Microbial Count of E.Faecalis after access opening and after BMP

Secondary Outcomes

  • Decrease in E. Faecalis Count(Decrease in E. Faecalis Count after 1 week placement of intracanal medicament (double antibiotic paste with normal saline/ double antibiotic paste with 2% chlorhexidine/ bioceramic based intracanal medicament))

Investigators

Sponsor
DR SHWETA
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr SHWETA

Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak

Study Sites (1)

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