| CTRI Number |
CTRI/2025/03/083186 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two intracanal medicaments in patients with periapical lesion and evaluate the healing of lesion after 3 months medication used are calcium hydroxide iodoform paste and triple antibiotic paste |
|
Scientific Title of Study
|
Comparative evaluation of calcium hydroxide iodoform based intracanal medicament and triple antibiotic paste an in vivo 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 |
Porkodi |
| Designation |
PG student |
| Affiliation |
Madha dental college and hospital |
| Address |
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
Chennai
TAMIL NADU
600069
India |
| Phone |
9944101719 |
| Fax |
|
| Email |
porkothangam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susila anand |
| Designation |
Professor and Head of the department |
| Affiliation |
Madha dental college and hospital |
| Address |
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
Chennai
TAMIL NADU
600069
India |
| Phone |
9445359842 |
| Fax |
|
| Email |
drsusila2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Porkodi |
| Designation |
PG student |
| Affiliation |
Madha dental college and hospital |
| Address |
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
madha dental college and hospital
department of conservative dentistry and endodontics
room no 5
kundrathur
Chennai
TAMIL NADU
600069
India |
| Phone |
9944101719 |
| Fax |
|
| Email |
porkothangam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madha dental college & hospital
madha nagar
somangalam road
kundrathur
chennai 600069
tamilnadu
india |
|
|
Primary Sponsor
|
| Name |
Madha dental college |
| Address |
Madha dental college
Madha nagar
somangalam road
kundrathur |
| 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 |
| porkodi |
Madha dental college and hospital |
Room no 5
Department of conservative dentistry and endodontics
madha dental college
Chennai
TAMIL NADU |
9944101719
porkothangam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madha Dental College and Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periapical lesion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr Susila Anand |
Professor and Head of the department
Department of conservative dentistry and endodontics
Madha Dental College and Hospital
kundrathur
chennai
|
| Comparator Agent |
Triple antibiotic paste |
It is a combination of three antibiotics namely ciprofloxacin metronidazole and minocyclin in equal ratio |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Permanent teeth(study sample is based on no. of roots)
Clinically diagnosed with chronic apical periodontitis
No history of antibiotics use in last 3 months |
|
| ExclusionCriteria |
| Details |
Periodontally compromised teeth with gradeIII mobility
Endodontically non-salvageable teeth
Immunocmpromised patients/systemic illness
Root anomalies
History of allergy to calcium hydroxide,iodoform and antibiotics in TAP
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
periapical lesion size reduction determined by periapical index score(PAI)
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical resolution of the symptoms |
clinical resolution of the symptoms |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
07/05/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Periapical lesion is caused due to dental caries, trauma, incomplete root canal treatment. Periapical lesion leads to weakening of bone surrounding the tooth. Non surgical lesion management is the noninvasive procedure for the treatment of periapical lesion, in which intracanal medicament is placed in the root canal of the tooth. The intracanal medicaments commonly used are calcium hydroxide, calcium hydroxide iodoform paste, double antibiotic paste, triple antibiotic paste. Non surgical lesion management also prevents surgical intervention. Here, in our vivo study we compared calcium hydroxide iodoform paste and triple antibiotic paste for the management of periapical lesion and evaluated the outcome after 3 months using periapical index score. |