To determine the efficacy of two commerically available herbal products during root canal treatment

Not yet recruiting

Registration Number: CTRI/2018/09/015627

Lead Sponsor: Sudha Rustagi Dental College

Brief Summary: Thirty patients with thirty single rooted teeth ofthe age 15-50 years will be selected for the study. Prior clearance of theprotocol from the Ethical committee and informed consent from each patient willbe taken.

Inclusion criteria: Patients with non-contributory medical history, intact permanent teethwithout any previous restoration, teeth with necrotic or infected pulp asdiagnosed clinically and radiographically, teeth with adequate coronalstructure for proper isolation, temporization, and restoration will beincluded.

Exclusion criteria : Patients with systemicconditions, acute periapical abscess, retreatment cases, patients on antibiotictherapy within three months, teeth with calcified canals, sinus opening,immature apex, internal or external resorption or periodontal pockets >5 mm willbe excluded.

INSTRUMENTATION:

FIRST TREATMENT SESSION:

Each tooth will be anaesthetized and isolated withrubber dam followed by caries removal. Oral cavity along with the experimentaltooth will be disinfected with the Betadine solution. Access cavity will beprepared and the working length will be determined radiographically by usingsize #10 K-file to the apex; this length will be premeasured and the workinglength will be set 1mm short of this distance. Pretreatment Sample (S1) will beobtained by injecting normal saline (5ml) into the root canal andcircumferentially pumping a #10 K-file (1 mm short of working length). A sterile paper point will be inserted afterimmersing it into the transport media and placing into the canal for 60 sec. Itwill be immediately transported to the test tube containing transport media.Three paper point samples will be taken for each tooth. Biomechanicalpreparation will be done using step back technique up to master apical size#40.The two experimental solutions and chlorhexidine gluconate as the positivecontrol will be used as irrigants as follows.

Group I: 2%Chlorhexidine gluconate

Group II: Neem Juice extract

Group III: Tulsi juice extract

Irrigation will be done with 6ml of the irrigants.Followed by collection of post instrumentation sample (S2) in the same manneras S1. It will be sent to laboratory for processing within 2 hours. Aftersecond sampling, the canals will be dried and the two experimental solutionsand chlorhexidine gluconate as the positive control will be used as medicamentsand placed inside the root canals:

Group I: 2%Chlorhexidine gluconate

Group II: Neem Juice extract

Group III: Tulsi juice extract

A cotton pellet will be placed inside the pulpchamber. Double seal of Cavit G will be placed.

SECOND TREATMENT SESSION-

Patients will be recalled after 7 days. Afterisolation and disinfection of the tooth and the oral cavity, the temporaryrestoration will be removed. Collection of post medication sample (S3) will betaken in the same manner as S1 and S2. Teeth will be obturated by lateralcondensation technique using 2% GP and AH plus as sealer and restored with composite.

Microbiological samples (S1, S2, S3) will bepreincubated for 30 minutes and shaken vigorously in a vortex mixture for 60seconds and then will be plated on Brain heart infusion agar and colonies willbe counted after 24 hours using classic bacterial counting method.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with non-contributory medical history, intact permanent teeth without any previous restoration, teeth with necrotic or infected pulp as diagnosed clinically and radiographically, teeth with adequate coronal structure for proper isolation, temporization, and restoration were included.

Exclusion Criteria

Patients with systemic conditions, acute periapical abscess, retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, sinus opening, immature apex, internal or external resorption, teeth with periodontal pockets >5 mm were excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in bacterial count	6 months

Secondary Outcome Measures

Name	Time	Method
Colony counts in different groups at stages S1, S2 and S3.	6 months

Trial Locations

Locations (1): Sudha Rustagi Dental College
🇮🇳
Faridabad, HARYANA, India
Sudha Rustagi Dental College
🇮🇳Faridabad, HARYANA, India
Rakesh Kumar
Principal investigator
9813172742
mttlrksh@yahoo.co.in