| CTRI Number |
CTRI/2023/11/059520 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Pain and Healing after Root Canal treatment in children using different concentration of cleaning solution |
|
Scientific Title of Study
|
Comparative Evaluation of Post Operative pain, Radiographic and Clinical successes of 1% Sodium hypochlorite and 3% Sodium hypochlorite used as irrigants during Pulpectomy: A Split Mouth Double Blinded Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Mukundan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
No 162, Poonamallee High Road,, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8220492973 |
| Fax |
|
| Email |
divyamukundan1694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Associate professor |
| Affiliation |
Saveetha dental college |
| Address |
No 162, Poonamallee High Road,, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
152111001.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Mukundan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
No 162, Poonamallee High Road,, Velappanchavadi, Chennai, Tamil Nadu 600077
TAMIL NADU
600077
India |
| Phone |
8220492973 |
| Fax |
|
| Email |
divyamukundan1694@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental college and Hospitals
162, Poonamallee High Road, Chennai 600077 India |
|
|
Primary Sponsor
|
| Name |
Divya Mukundan |
| Address |
162, Poonamallee High Road, Chennai 600077 India |
| 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 Divya Mukundan |
Saveetha Dental college and Hospitals |
162, Poonamallee High Road, Chennai 600077 India
Department of Pediatric and Preventive Dentistry, clinic no:28(5th floor)
Chennai
TAMIL NADU |
8220492973
divyamukundan1694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Patients requiring pulpectomy procedures on lower teeth due to dental caries and pain |
| Patients |
(1) ICD-10 Condition: Z918||Other specified personal risk factors, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sodium hypochlorite solution used for irrigation of root canal |
1% sodium hypochlorite solution, 1 ml to be used intracanally (inside the root canal) for 1 minute. |
| Comparator Agent |
Sodium hypochlorite solution used for irrigation of root canal |
3% sodium hypochlorite solution, 1 ml to be used intracanally (inside the root canal) for 1 minute. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients, Teeth with apical periodontitis after clinical and radiographic confirmation, Presence of 2/3rd of root length and mandibular primary molars |
|
| ExclusionCriteria |
| Details |
Any known history of allergy to any medications; Medically compromised children; tooth with complications such as perforations, fractures and root calcifications, children not under any analgesics or anti-inflammatory drugs for the past 1 week |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic success
clinical success |
3 months, 6 months, 9 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
In this split-mouth, double-blinded randomized control trial, we aimed to compare the efficacy of two different concentrations of sodium hypochlorite, 1% and 3%, as irrigants during pulpectomy procedures. The study will assess post-operative pain, radiographic success, and clinical outcomes in patients with similar pulp pathologies. Both patients and the observer were blinded to the sodium hypochlorite concentration used on each side of the mouth to minimize bias. Post-operative pain was evaluated using standardized pain scales; radiographic success was determined through pre-operative and post-operative radiographs taken at an interval of 3 months, 6 months, 9 months, and 12 months; and clinical success was assessed through clinical examinations and patient-reported outcomes at an interval of 3 months, 6 months, 9 months, and 12 months. The results of this trial will provide valuable insights into the impact of sodium hypochlorite concentration on the overall success of pulpectomy, aiding pedodontists in making informed decisions regarding the choice of irrigation solution for improved patient outcomes and quality of care. |