Comparing the Effects of Different Natural Biotic Irrigants on Infection and Inflammation in Childrens Teeth.

Phase 3

Not yet recruiting

Conditions: Pulpitis,

Registration Number: CTRI/2025/04/084899

Lead Sponsor: Not Applicable

Brief Summary: Successful endodontic treatment relies onthe complete eradication of microbialpathogens and resolution of periradicularinflammation. Persistent infections, often caused bymicrobial biofilms within the root canal system, are a major cause of treatmentfailure. Various traditionally used chemicalirrigants have certain limitations which has led to increased attention towards biologicallyderived irrigants for their potential to provide antimicrobial efficacy whileminimizing adverse effects. The increasing focusand limited scientific evidence on biologically derived irrigants specificallybiotic formulations necessitates scientific evaluation of their antimicrobialefficacy. Also, there is apaucity in studies evaluating the changes in biomarker levels during pulpectomyprocedures in primary teeth. Therefore it is critical to addressthese gaps by exploring the efficacy of biotics as irrigants and assessing theutility of periradicular biomarkers to enhance the understanding andeffectiveness of pulpectomy in primary molars.

1. The subjects willbe made to sit comfortably in dental operatory room. The intra-oral examinationwill be done wearing a mouth mask and sterile latex gloves.

2. A periapicalradiograph will be taken in Bucco - lingual projection for proper toothselection.

3. Following LocalAnesthesia administration using 2% Lignocaine with 1 : 80,000 Adrenaline,initial caries will be removed and endodontic access cavity preparation will bedone

4. Prior toinstrumentation with any endodontic files Sample S1 will be collected usingthree presterilized paper points introduced consecutively into the canal toextend 2 mm beyond the apex (as measured radiographically) and left undisturbedfor one minute.

5. Then the samplewill be transferred into presterilized Eppendorf tube of 2 ml PBS TM forculture. The tube will be transferred within 10 min for microbial culturing.For Periradicular biomarker analysis the sample will be collected in PBS TM andstored in the freezing unit of temperature -80 C until ELISA test is done.

6. Working lengthwill be then determined using an electronic apex locator and confirmedradiographically.

7. The root canalswill be cleaned and shaped using #10, #15 files followed by pediatric hand orrotary files.

8. Each patient willbe randomly allotted by lottery method to one of the five groups for Irrigation: Group 1 : Control (Saline) Group 2 : Prebiotic irrigant Group 3 : Probiotic irrigant Group 4 : Synbiotic irrigant Group 5 : Postbioticirrigant

9. Copiousirrigation of the root canal will be followed by sample collection S2

10. Post Irrigation,canals will be dried and closed cotton dressing with temporary restoration willbe given and the patient will be recalled after 72 hours.

11. After 72 hours,Temporary Restoration will be removed and Sample collection S3 will be done

12. Canals will bedried with absorbent paper point and followed by obturation with Metapex(Calcium hydroxide with iodoform paste). Final Restoration using Glass IonomerCement will be done.

13. The samples S1& S2 will be tested for Colony forming Units on Blood Agar Plates.

14. The samples S1& S3 will be tested using ELISA kit for levels of IL8 and IL10.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

a)Normal, Healthy Children between 4 to 9 years b)Primary molars with irreversible pulpitis c)Primary molars roots should exhibit minimal or no resorption.
d)IOPA Radiograph examination revealing primary molars with two thirds of each root remaining.

Exclusion Criteria

a)Primary molars with perforated pulpal floor and sinus tract.
b)Primary molars with intraoral & extraoral swelling.
c)Primary molars with Grade III, IV mobility.
d)Children with special healthcare needs and systemic disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the antimicrobial efficacy of different irrigants - prebiotic, Probiotic, Synbiotic and Postbiotic Irrigants — in primary molars during pulpectomy.	1. Microbial load evaluated pre and post irrigation \| 2. levels of Periradicular inflammatory biomarkers to be evaluated pre and post 72 hours of irrigation
2. To assess changes in the levels Periradicular inflammatory biomarkers (IL-8, IL-10) before irrigation and 72 hours after irrigation with different irrigants.	1. Microbial load evaluated pre and post irrigation \| 2. levels of Periradicular inflammatory biomarkers to be evaluated pre and post 72 hours of irrigation

Secondary Outcome Measures

Name	Time	Method
To develop a novel biologically derived irrigant for better treatment outcome for pediatric patient.	Pre and Post Irrigation

Trial Locations

Locations (1): Manav Rachna Dental College
🇮🇳
Faridabad, HARYANA, India
Manav Rachna Dental College
🇮🇳Faridabad, HARYANA, India
Sushree Manaswinee
Principal investigator
8073788286
sushree99.sm@gmail.com