| CTRI Number |
CTRI/2024/09/073835 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
No |
| 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 efficacy of calcium hydroxide, herb Mimusops elengi and Tribulus terrestris as an intracanal medicament on aerobes and facultative anerobes |
|
Scientific Title of Study
|
A randomized clinical trial to evaluate and compare antimicrobial efficacy of calcium hydroxide, herb Mimusops elengi and Tribulus terrestris as an intracanal medicament on aerobes and facultative anerobes |
| 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 Hospital |
| Address |
SDM College of Dental Sciences and Hospital
Department of pediatric and preventive Dentistry SDM College of
Dental Sciences and Hospital Sattur,Dharwad
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
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
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
Dharwad Karnataka India 580009 |
| 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 |
| Intervention |
calcium hydroxide intracanal
medicament
|
calcium hydroxide powder dose
0.22g Frequency baseline 15th
day 30th day Route of
administration intracanal
Duration 30days |
| Comparator Agent |
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 endodontictreatment
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 herbal
Mimusops elengi, Tribulus terrestris as an
intracanal medicament on aerobes and facultative anaerobes colony
forming units over 4 weeks of time period comparing with calcium hydroxide (control) 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.
• 2 weeks follow up with sample collection for
microbiological analysis of E.faecalis.
• 4 weeks follow up with sample collection for
microbiological analysis of E.faecalis.
Time of assessment are first day, 2weeks and
4 weeks |
|
|
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="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/09/2024 |
| Date of Study Completion (India) |
27/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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 aerobes and facultative anaerobes 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 aerobes and facultative anaerobes 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 aerobes and facultative anaerobes by collecting the samples from root canals of permanent teeth.
Study design: 27 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 9 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 aerobes and facultative anaerobes
|