| CTRI Number |
CTRI/2023/03/050533 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating intracanal medicaments to reduce microbial count in root canal and inflammation reduction in tooth infection - Randomized controlled trial |
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Scientific Title of Study
|
CLINICAL INVESTIGATION OF ANTIMICROBIAL EFFICACY AND RESOLVIN E1 IMMUNOEXPRESSION USING CHITOSAN, N- ACETYL CYSTEINE AND CALCIUM HYDROXIDE INTRACANAL MEDICAMENTS IN APICAL PERIODONTITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subiksha kannan |
| Designation |
Post graduate |
| Affiliation |
SCB Dental College & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Cuttack
ORISSA
753007
India |
| Phone |
9677963550 |
| Fax |
|
| Email |
subikshakannan12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Jena |
| Designation |
Professor |
| Affiliation |
SCB Dental College & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Cuttack
ORISSA
753007
India |
| Phone |
9437836499 |
| Fax |
|
| Email |
amitjena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Subiksha kannan |
| Designation |
Post graduate |
| Affiliation |
SCB Dental College & Hospital |
| Address |
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag
Cuttack
ORISSA
753007
India |
| Phone |
9677963550 |
| Fax |
|
| Email |
subikshakannan12@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Dental College and Hospital, Cuttack, Orissa |
|
|
Primary Sponsor
|
| Name |
Subiksha Kannan |
| Address |
Department of Conservative Dentistry and Endodontics,
SCB Dental College and Hospital, Manglabag |
| Type of Sponsor |
Other [Principal Investigator] |
|
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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 |
| Subiksha Kannan |
SCB Dental college and Hospital |
Department of Conservative Dentistry and Endodontics, First floor, SCB Dental College and Hospital, Manglabag
Cuttack
ORISSA |
9677963550
subikshakannan12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SCB Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium hydroxide (35%) |
DOSE:20 mg FREQUENCY: Once ROUTE OF ADMINISTRATION:local application inside the root canal using lentulospiral DURATION OF INTERVENTION: 7 days placement in the root canal |
| Intervention |
Chitosan (2%) |
DOSE:20 mg FREQUENCY: Once ROUTE OF ADMINISTRATION:local application inside the root canal using lentulospiral DURATION OF INTERVENTION: 7 days placement in the root canal |
| Intervention |
N - Acetyl Cysteine (1gm/1ml) |
DOSE:20mg
FREQUENCY: Once
ROUTE OF ADMINISTRATION:local application inside the root canal using lentulospiral
DURATION OF INTERVENTION: 7 days placement in the root canal |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Single-rooted
2. Pulp necrosis and apical periodontitis
3. Presence of one root canal.
|
|
| ExclusionCriteria |
| Details |
1. Patients who used antibiotics or antifungal medications in the past three months.
2. Root canal treated teeth
3. Any systemic disease
4. Periodontal pockets deeper than 4 mm
5. Teeth that could not be adequately isolated with a rubber dam
6. Acute apical abscess
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of microbial load |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of RvE1 in periapical tissues |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION: One of the primary goals of root canal treatment is to eliminate or reduce the levels of microorganisms present in root canals below a threshold compatible with the healing of periapical tissues.‘Programmed resolution’ at the tissue level involves the participation of resolvins, a type of immuno resolvents, which actively drive the resolution of inflammation. Embracing the concept of ‘natural resolution of inflammation’ and the aim of healing through tissue regeneration, an ideal intracanal medication should possess numerous desirable properties, such as antimicrobial activity, biocompatibility, and also must be capable of promoting endogenous production of lipid mediators that actively drive the resolution of inflammation.
AIM: The aim of the present study is to clinically investigate the antimicrobial efficacy of chitosan, N- acetyl cysteine and calcium hydroxide as intracanal medicaments and their influence on level of inflammatory mediator Resolvin E1 in apical periodontitis. JUSTIFICATION: Only one RCT evaluating the influence of intracanal medicaments on the levels of resolvins in apical periodontitis and one RCT evaluating antimicrobial efficacy of chitosan. METHODOLOGY: Root canal procedure will be performed by single Post-Graduate student under strict aseptic condition with local anesthesia (2% lidocaine & epinephrine at 1:200000) and rubber dam isolation. After complete instrumentation and irrigation, the teeth will be randomly divided into three groups according to the intracanal medicaments to be used. GROUPS: Group I : Chitosan (n=20) Group II: N - Acetyl cysteine (n=20) Group III: Calcium hydroxide (n=20) Samples for microbiological analysis and resolvin level evaluation will be done before and after intracanal medicament placement.
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