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CTRI Number  CTRI/2025/07/091633 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the clinical success of three ayurvedic products used as root canal filling materials: a 12 month followup study. 
Scientific Title of Study   Comparative evaluation of clinical and radiographical success of pulpectomized primary molars using three herbal additives to zinc oxide as obturating materials :A 12 month followup study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Marathe Sanveed Sunil 
Designation  Post graduate student 
Affiliation  Rajarajeswari dental college and hospital, Bangalore 
Address  Department of pediatric and preventive dentistry Room number 5,Rajarajeswari dental college and hospital, ramohalli cross, mysore road bangalore Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  08879856049  
Fax    
Email  drsanveedmarathe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. B.S. Shakuntala 
Designation  HOD AND PROFESSOR 
Affiliation  Rajarajeswari dental college and hospital, Bangalore 
Address  Department of pediatric and preventive dentistry Room number 5,Rajarajeswari dental college and hospital, ramohalli cross, mysore road bangalore Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9945380455  
Fax    
Email  shakuntalabethur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Marathe Sanveed Sunil 
Designation  Post graduate student 
Affiliation  Rajarajeswari dental college and hospital, Bangalore 
Address  Department of pediatric and preventive dentistry Room number 5,Rajarajeswari dental college and hospital, ramohalli cross, mysore road bangalore Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  08879856049  
Fax    
Email  drsanveedmarathe@gmail.com  
 
Source of Monetary or Material Support  
Rarajeswari dental college and hospital No 14 ramohalli cross kumbhalgodu bengaluru karnataka 560074 
 
Primary Sponsor  
Name  Dr Marathe Sanveed Sunil 
Address  Department of pediatric and preventive dentistry Room number 5,Rajarajeswari dental college and hospital, ramohalli cross, mysore road Bangalore Karnataka 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Marathe Sanveed Sunil  Rajarajeswari dental college and hospital  Department of pediatric and preventive dentistry Room number 5,Rajarajeswari dental college and hospital, ramohalli cross, mysore road bangalore Karnataka
Bangalore
KARNATAKA 
08879856049

drsanveedmarathe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: K040||Pulpitis, (3) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Zinc oxide and curcumin  intervention for 3 6 9 12 months 
Intervention  Zinc oxide and neem  intervention for 3 6 9 12 months 
Intervention  Zinc oxide and propolis  intervention for 3 6 9 12 months 
Intervention  Zinc oxide eugenol   intervention for 3 6 9 12 months 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Tooth with presence of deep carious lesion or teeth having carious exposure to pulp
Tooth with radiographic evidence of deep carious lesion and 2/3rd of root length present
having adequate bone coverage
Tooth with presence or absence of intraradicular or periradicular radiolucency not
involving permanent tooth bud.
Tooth with any sign of inflammation if present. 
 
ExclusionCriteria 
Details  Teeth with extensive root resorption
Teeth that present pathological mobility or mobility due to physiologic resorption
Non restorable primary molars
Teeth with perforated pulpal floors
Teeth with inadequate bone support
Children with intake of antibiotics 2 weeks prior to treatment
Fractured teeth
Children with major systemic illness 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare and evaluate success rate of herbal additives to zinc oxide as obturating materials in pulpectomized primary molars  Base line
3 month
6 month
9 month
12 month
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The complex root canal system of primary teeth makes it difficult to achieve proper chemomechanical debridement Hence obturating materials having good antimicrobial properties is crucial for better prognosis Conventional materials like zinc oxide eugenol and calcium hydroxide have been successfully used as obturating materials in pediatric endodontics but have limited anti-microbial action Herbal alternatives that have therapeutic and broader and more effective antibacterial properties are being exploredCurcumin the bioactive component of turmeric has wide spectrum of anti-inflammatory antioxidant anti-carcinogenic anti-bacterial and anti-fungal propertiesAzadirachta Indica Neem has immunomodulatory antifungal antimicrobial anti-inflammatory and anti-oxidant propertiesPropolis a natural bee hive product contains flavanoids phenolics and other aromatic compounds which has potent antibacterial and anti-inflammatory properties Over the years several undermining disadvantages like periapical irritation inflammation and cemental necrosis have emerged Considering the effective and beneficial properties of Curcumin Neem and Propolis the aim of this in vivo study is to evaluate and compare the clinical and radiographical success of three different herbal additives to Zinc Oxide as obturating materials at 3 6 9  12 months 

  • An aseptic technique will be used throughout the endodontic treatment. A single visit or multi visit pulpectomy will be performed by single operator using basic behaviour management techniques. Topical anesthetic gel will be applied. 2% lignocaine is administered at site after sub cutaneous patch test through 2.5ml disposable luerlock syringe. Rubber dam isolation will be done. The access to pulp chamber will be done with sterile water cooled high speed handpiece using diamond round bur (#330) followed by Endo Z after removal of carious tooth structure. The coronal pulp will be removed with help of spoon excavator. The radicular pulp is extripated using a barbed broach. The working length will be recorded using intraoral periapical radiograph 1 mm short of radiographic apex using Ingle’s method. Biomechanical preparation will be done using K files with step back technique along with thorough and copious irrigation with saline and 2.5% Sodium Hypochlorite.

    The prepared teeth will be randomly divided into 4 experimental groups and will be obturated

    ·          Experimental Group I – 25 teeth will be obturated using Zinc Oxide and Eugenol

               (Control)

    ·         Experimental Group II -  25 teeth will be obturated using Zinc Oxide + Curcumin

    ·         Experimental Group III -  25 teeth will be obturated using Zinc Oxide + Neem

    ·         Experimental Group IV -  25 teeth will be obturated using Zinc Oxide + Propolis

     

    Paper points are used for drying the canals prior to obturation.

    SUCCESS OF OBTUARTED MATERIALS WILL BE  DETERMINED BY

    ·         CLINICAL CRITERIA

    ·         RADIOGRAPHICAL CRITERIA

    CLINICAL CRITERIA                                                   SCORING CRITERIA

     

    ·         Presence/absence of Pain                                                    Absence – 0

    ·         Presence / absence of Gingival Swelling /Abscess             Presence - 1

    ·         Presence/absence of Mobility

    ·         Presence / absence on Tenderness On Percussion

     

    The numerical value of Score 0 will be given for Absence of and Score 1 will be given for Presence of the symptoms.

     

    ·         RADIOGRAPHICAL CRITERIA                                  SCORING CRITERIA

    ·         Presence/Absence of Periradicular and Furcal Radiolucency

    ·         Presence/Absence of Internal Root Resorption                      Absence – 0

    ·         Presence/Absence of External Root Resorption                     Presence – 1

     

    The numerical value of Score 0 will be given for Absence of and Score 1 will be given for Presence.


 
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