| CTRI Number |
CTRI/2017/08/009301 [Registered on: 08/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
To check outcome of root canal therapy after using different endodontic irrigation protocols in root canal therapy of primary teeth
|
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Scientific Title of Study
|
Effect of three endodontic irrigation protocols on quality of obturation and outcome of root canal therapy in primary teeth- A randomized clinical trialâ€
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neetu jain |
| Designation |
MDS Student |
| Affiliation |
MM.College Of Dental Sciences And Research, MM University Mullana,Ambala |
| Address |
Department of pediatric and preventiv dentistry. MM.College Of Dental Sciences And Research, MM University Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
09813094542 |
| Fax |
|
| Email |
jain.neetujain@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Garg |
| Designation |
Professor |
| Affiliation |
MM.College Of Dental Sciences And Research, MM University Mullana,Ambala |
| Address |
Department of pediatric and preventiv dentistry. MM.College Of Dental Sciences And Research, MM University Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
9215668621 |
| Fax |
|
| Email |
shaloosandeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetu jain |
| Designation |
MDS Student |
| Affiliation |
MM.College Of Dental Sciences And Research, MM University Mullana,Ambala |
| Address |
Department of pediatric and preventiv dentistry. MM.College Of Dental Sciences And Research, MM University Mullana,Ambala
Ambala
HARYANA
133207
India |
| Phone |
09813094542 |
| Fax |
|
| Email |
jain.neetujain@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry.MM.College Of Dental Sciences And Research, MM University Mullana,Ambala |
|
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Primary Sponsor
|
| Name |
MMCollege Of Dental Sciences And Research MM University MullanaAmbala |
| Address |
Department of pediatric and preventive dentistry.MM.College Of Dental Sciences And Research, MM University Mullana,Ambala |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetu jain |
Department of pediatric & preventive dentistry, MM college of dental sciences & research , Mullana |
Room No. 4, MM college of dental sciences & research , Mullana. 133203
Ambala
HARYANA |
09813094542
jain.neetujain@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Maharishi markandeshwar university , Mullana |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth with pulpal involvement indicative of irreversible pulpitis |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Normal saline 5 ml
2. sodium hypochlorite 5ml
3. citric acid 5ml |
Root canals will be irrigated with different irrigating solutions with and without endoactivator. |
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. History of spontaneous pain
2. Continuous bleeding after amputation of coronal pulp tissue
3. Teeth with pulpal involvement indicative of irreversible pulpitis
|
|
| ExclusionCriteria |
| Details |
1. Unrestorable tooth
2. Tooth with inter-radicular or periapical radiolucency involving more than half of the shortest root, measured vertically
3. Tooth with internal root resorption
4. Physiological or pathological external root resorption of more than a third of its length
(v) Obliteration of the root canal
(vi) Inadequate bone support evidenced by nonphysiological tooth mobility when compared with the contralateral tooth
(vii) Clinical signs and symptoms of an active spreading infection with systemic involvement that require antibiotic therapy such as tachycardia, facial swelling, cellulitis, limited mouth opening, high temperature, difficulty in swallowing, and regional lymphadenitis
(viii) Anatomic anomalies
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| A. The quality of the filled canals will be assessed |
The quality of the filled canals will be assessed immediately after root canal obturation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Clinical evaluation:
The clinical evaluating features will be Pain, Swelling, Fistula, Sensivity to purcussion. |
Clinical follow up will be done at 1 week, 1 month, 6 month, 9 month.
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2014 |
| Date of Study Completion (India) |
30/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The
main purpose of our randomized clinical trial is to evaluate the outcome of
pulpectomy with or without smear layer removal because the effect of smear
layer removal on primary teeth has not been well elucidated.The study will be
conducted in the age group of 3-9 years old children in the Department of
Pediatric and Preventive Dentistry, M. M. College of Dental Sciences and
Research, Mullana. Screening will be conducted
in ‘n’ no. of patients for cases who require pulpectomy for deciduous teeth
within the age groups of 3 to 9 years.A total of minimum 40 teeth will be included in the study using the
following inclusion & the exclusion criteria after the consent of
participation will be obtained from their parents/guardian.Once eligibility will be confirmed the treatment procedure will be
explained to the parent & after explaining the clinical procedures, informed
consent will be obtained from parents showing willingness for their child’s
participation. Only one operator will perform all the procedures. A total of 40 teeth will be recruited in the study and will be
randomly distributed by chit method in 3 trials and 1 control group. The
quality of the filled canals will be assessed . Also the clinical and radiographic follow up will be done.The
results will be analyzed statistically using appropriate test.
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