| CTRI Number |
CTRI/2024/06/068437 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate and compare antimicrobial effectiveness of calcium hydroxide, herb Mimusops elengi and Tribulus terrestris as an intracanal medicament on Enterococcus fecalis |
|
Scientific Title of Study
|
A Randomized Clinical Trial to evaluate and compare antimicrobial efficacy of calcium hydroxide herbal Mimusops elengi and Tribulus terrestris as an intracanal medicament on Enterococcus faecalis in permanent teeth |
| 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 Tejashwi K S |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Dental Sciences and Hospiatl |
| Address |
Department of pediatric and preventive Dentistry
SDM College of Dental Sciences and Hospital
Sattur,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
08861398502 |
| Fax |
|
| Email |
karthurashetal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruthi B Patil |
| Designation |
Professor,Pediatric and Preventive Dentistry |
| Affiliation |
SDM College of Dental Sciences and Hospiatl |
| Address |
Department of pediatric and preventive Dentistry
SDM College of Dental Sciences and Hospital
Sattur,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7760372185 |
| Fax |
|
| Email |
shruthirajpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruthi B Patil |
| Designation |
Professor,Pediatric and Preventive Dentistry |
| Affiliation |
SDM College of Dental Sciences and Hospiatl |
| Address |
Department of pediatric and preventive Dentistry
SDM College of Dental Sciences and Hospital
Sattur,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7760372185 |
| Fax |
|
| Email |
shruthirajpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Dental Sciences & Hospital a constituent unit of Shri Dharmasthala Manjunatheshwara University
Sattur, Dharwad Karnataka India 580009 |
|
|
Primary Sponsor
|
| Name |
DrTejashwi K S |
| Address |
Department of Pediatric and Preventive dentistry
SDM College of Dental Sciences
and Hospital |
| 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 Tejashwi K S |
SDM College of Dental Sciences and Hospital |
Department of Pediatric and Preventive Dentistry
SDM College of Dental Sciences and Hospital
Dharwad
KARNATAKA |
8861398502
karthurashetal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College Of Dental Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium hydroxide intracanal medicament |
calcium hydroxide powder
dose 0.22g Frequency baseline 15th day 30th day Route of administration intracanal Duration 30days |
| Intervention |
M.elengi herbal intracanal medicament |
Raw powder of M.elengi
dose
0.22g
frequency
baseline
15th day
30th day
Route of administration intracanal
Duration
30 days
|
| Comparator Agent |
T.terrestris intracanal medicament |
Raw powder of T.terrestris
dose
0.22g
frequency
baseline
15th day
30th day
Route of administration intracanal
Duration
30 days
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Permanent teeth with periapical lesion requiring endodontic treatment.
2.Distinct periapical changes visible on intraoral periapical radiograph of
permanent teeth.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with evident clinical signs of extra oral swelling, space infections.
2.Patient on long-term antibiotic therapy, steroid therapy.
3.Patients with any systemic diseases.
4.Grossly decayed tooth indicated for extraction.
5.Parents who deny providing the consent and participation for the study.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the antimicrobial efficiency of Mimusops elengi, Tribulus terrestris as an intracanal medicament on E.faecalis colony forming units over 30 days time period when compared with calcium hydroxide on permanent teeth by assessing history of pain tenderness on percussion absence of abscess or sinus discharge
|
• 1st day –baseline sample collection for microbiological analysis of E.faecalis.
• 15 day follow up with sample collection for microbiological analysis of E.faecalis.
• 30 day follow up with sample collection for microbiological analysis of E.faecalis.
Time of assessment are first day 15th day and 30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the success rate of endodontic therapy over a period of 30 days based on the parameters like absence of pain tenderness to vertical percussion discharge or swelling suggestive of periapical healing |
15 days & 30 days post placement of intracanal medicament |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
26/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: The root canal treatment focuses at the complete elimination of microbes from the pulp space. This is achieved through chemo-mechanical preparation followed by three dimensional obturation. The persistent bacterium such as E. faecalis in the intricacies of pulp spaces poses a problem of endodontic treatment failure. To prevent such failures, Chemo-mechanical preparation along with the placement of intracanal medicament enhances the elimination of microbes and healing. Thus, this study aims to evaluate and compare antimicrobial Efficacy of calcium hydroxide, herbal Mimusops elengi andTribulus terrestris as an intracanal medicament on Enterococcus faecalis in permanent teeth.
Objectives: To evaluate and compare the antimicrobial efficacy of calcium hydroxide, herbal preparation of Mimusops elengi and Tribulus terrestris as an intracanal medicament on bacteria Enterococcus faecalis by collecting the samples from root canals of permanent teeth.
Study design: 81 patients between the age of 6 to 14 years requiring root canal therapy will be selected for the study and will be randomly divided into 3 groups of 27 participants each namely:
oGroup A - Control; a mixture of Calcium Hydroxide with saline will be placed as an intracanal medicament.
oGroup B - a mixture of fine powder of Mimusops Elengi with saline will be placed as an intracanal medicament.
oGroup C - a mixture of fine powder of Tribulus Terrestris with saline will be placed as an intracanal medicament.
Three intracanal samples will be collected for each patient comprising of one baseline sample, two samples post placement of intracanal medicament after an interval of 15 and 30 days respectively. These collected samples will be sent to the laboratory for microbiological analysis to check the Colony Forming Unit counts of bacteria E.faecalis. The data collected will be tabulated and sent for statistical analysis. |