| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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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
|
T he 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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