| CTRI Number |
CTRI/2025/02/081024 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Success Rate of Two Different Antibiotic Treatments for Saving Decayed Baby Teeth: A Triple-Blinded, Randomized Study |
|
Scientific Title of Study
|
Survival Rate of Lesion Sterilization and Tissue Repair Using Triple Antibiotic and Double Antibiotic Paste in Primary Molars: A Triple-Blinded, Randomized Controlled 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 |
Dr Shaniya Sain |
| Designation |
Professor,PhD Scholar |
| Affiliation |
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research,
Golden Hills,Vencode PO,
Vattapara,Trivandrum.
PIN -695028
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8590958590 |
| Fax |
|
| Email |
shnsain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sageena George |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
PMS College of Dental Science and Research,
Vattapara,
Trivandrum.695028
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447823844 |
| Fax |
|
| Email |
drsajeenajosek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaniya Sain |
| Designation |
Professor, PhD Scholar |
| Affiliation |
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research,
Golden Hills,Vencode PO,
Vattapara,Trivandrum.
PIN -695028
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8590958590 |
| Fax |
|
| Email |
shnsain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry
PMS College of Dental Science and Research,
Golden Hills,Vencode PO,
Vattapara,Trivandrum.
PIN -695028
|
|
|
Primary Sponsor
|
| Name |
PMS College of Dental Science and Research |
| Address |
PMS College of Dental Science and Research,
Golden Hills,Vencode PO,
Vattapara,Trivandrum.
PIN -695028
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shaniya Sain |
PMS College of Dental Science and Research |
Department of Pediatric and Preventive Dentistry,
Golden Hills,Vencode PO,
Vattapara,Trivandrum.
PIN -695028
Thiruvananthapuram
KERALA |
8590958590
shnsain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMS College of Dental Science and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-1: Patients will be treated with 3-mix paste and will act as the working control. |
Children aged 4–8 years with compromised, infected primary molars indicated for LSTR will be selected from the Pediatric Dentistry Department at PMS College of Dental Science and Research. Ethical clearance has been obtained, and informed consent will be obtained from parents after providing study details in English and Malayalam, excluding material names for blinding. A detailed medical and dental history, clinical examination, and preoperative radiographs will be conducted, with assessments scored using a validated composite index. Periapical radiographs will be standardized using digital overlay and expert calibration. Triple Antibiotic Paste (TAP) will be prepared in a 1:1:1 using Metronidazole, Ciprofloxacin, and Clindamycin for TAP. The paste will be mixed with propylene glycol for uniform consistency and stored under controlled conditions. The treatment will involve local anesthesia, rubber dam isolation, access cavity preparation, and irrigation with saline and sodium hypochlorite. A medication cavity will be prepared, and TAP will be placed before final restoration with glass ionomer cement and a stainless steel crown. Clinical and radiographic evaluations will be conducted every six months for two years, with success and failure categorized based on a validated composite index. |
| Intervention |
Group-2: Patients will be treated with 2-mix paste and will act as the experimental group. |
The study protocol is same as in the comparater group except for the agent prepared and used. Double Antibiotic Paste (DAP) will be prepared in a 1:1 ratio, respectively, using Metronidazole and Ciprofloxacin for DAP. The paste will be mixed with propylene glycol for uniform consistency and stored under controlled conditions. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Advanced root resorption more than two-thirds.
Severe bone loss in the furcal and periapical area due to pulpitis.
Pathologic mobility due to periapical infection from pulpities.
Radiolucency in the furcal area.
Patients not willing for extraction.
Presence of abscess
Presence of sinus
|
|
| ExclusionCriteria |
| Details |
Children with systemic disease.
Children with allergies to antibiotics.
Developmentally and medically compromised children.
Teeth with perforated floor.
Excessive bone loss in the furcation area extending to the crypt of underlying tooth bud.
Non-restorable crown
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Criteria:
Immediate post-operative absence of spontaneous pain
No tenderness to percussion
No mobility
No intraoral or extraoral swelling
No sinus tract
Radiographic Criteria:
Internal root resorption
External root resorption
Bone resorption / Peri-radicular radiolucency
Cyst formation |
Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Survival Rate Evaluation:
Categorization of success and failure will be defined and calculated using the validated composite index.
|
first month,every 6 months for a period of 2 years |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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 4 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="3"
Months="0"
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
|
not applicable |