| CTRI Number |
CTRI/2022/05/042944 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of different concentrations of antibiotic paste for treatment of carious and infected lower posterior primary teeth in children |
|
Scientific Title of Study
|
Comparative Evaluation of Lesion Sterilization and Tissue Repair in Pulpally Involved Primary Molars using Modified Triple Antibiotic Paste with Different Concentrations: An In Vivo Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mainak Das |
| Designation |
Post Graduate MDS Student |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Paediatric and Preventive Dentistry GNIDSR 6th Floor Room no.1 157/F Nilgunj Road Panihati Kolkata West Bengal 700114
Kolkata WEST BENGAL 700114 India |
| Phone |
9433291551 |
| Fax |
|
| Email |
drmdas85@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shabnam Zahir |
| Designation |
Professor and HOD |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Paediatric and Preventive Dentistry GNIDSR 6th floor Room no 4 157/F Nilgunj Road Panihati Kolkata West Bengal 700114
Kolkata WEST BENGAL 700114 India |
| Phone |
9830215726 |
| Fax |
|
| Email |
dr.shabnam.zahir@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mainak Das |
| Designation |
MDS Postgraduate Student |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Paediatric and Preventive Dentistry GNIDSR 6th floor Room no 1 157/F Nilgunj Road Panihati Kolkata West Bengal
Kolkata WEST BENGAL 700114 India |
| Phone |
9433291551 |
| Fax |
|
| Email |
drmdas85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road Panihati Kolkata West Bengal 700114 |
|
|
Primary Sponsor
|
| Name |
Dr Mainak Das |
| Address |
42/103, New Ballygunge Road, Nirmal Tara Apartment, Kolkata 700039 |
| 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 Mainak Das |
Guru Nanak Institute of Dental Sciences and Research |
Department of Paediatric and Preventive Dentistry 6th Floor Room no 2 157/F Nilgunj Road Panihati Kolkata West Bengal 700114 Kolkata WEST BENGAL |
9433291551
drmdas85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Nanak Institute of Dental Sciences and Research Panihati Kolkata 700114 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Triple Antibiotic Paste consisting of Ciprofloxacin, Metronidazole and Amoxicillin in three different concentrations 0.5 mg/ml, 2.5 mg/ml and 5 mg/ml |
An in vivo interventional study will be conducted among children of age group 5-9 years with indication for pulp therapy using Modified Triple Antibiotic Paste (Ciprofloxacin, Metronidazole and Amoxicillin) in three different concentrations (0.5 mg/ml, 2.5 mg/ml and 5 mg/ml) for LSTR of primary molars and comparative evaluation of clinical and radiographic success of LSTR will be done at specific time intervals. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with deep caries involving pulp in primary molars, Irreversible pulpitis, Irreversible pulpitis with apical periodontitis, Primary molar with at least two-thirds of the roots, Primary molar with restorable crown structure |
|
| ExclusionCriteria |
| Details |
Primary molar with dentigerous cyst, Special children with a physical or emotional alteration, Children with systemic diseases, Previous
history of allergy to antibiotics used in the study, Caries in primary teeth exhibiting pre-shedding mobility, Carious perforation of floor of primary molar, Molar with more than 2/3rd root resorbed, Molars with gross destruction of alveolar bone, Molar with non restorable crown structure |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain, swelling and mobility (other than shedding mobility) in primary infected molars |
3, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic evidence of decrease in intra radicular radiolucency, continuity of lamina dura and absence of internal resorption |
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
10/06/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Maintenance of primary dentition is imperative for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss can cause various problems such as ectopic eruption, space loss for the successor permanent teeth, alterations in speech, and impairment of function. Hence, decayed primary teeth should not be extracted and treated whenever possible. Pulpectomy is generally recommended as a treatment of choice in such cases. But several factors make conventional pulpectomy arduous. The typical primary tooth morphology (tortuous root canals, presence of multiple accessory canals, ramifications, and ample medullary bone spaces that favor dissemination of infection) often presents a challenging task to the clinician. In addition to that, obtaining a hermetic seal is difficult due to the lack of apical closure following physiologic root resorption owing to the proximity of the developing permanent tooth germ to the roots of the primary teeth. A further challenge presented to the dentist in rendering effective endodontic treatment is the behavior management of uncooperative children. Thus to overcome these hurdles, the concept of lesion sterilization and tissue repair (LSTR) which involves the topical placement of triple antibiotic pastes (TAPs) evolved which aims to disinfect the canal space thus promoting repair of damaged tissue. LSTR involves the use of three antibiotics/antibacterial drugs namely, Metronidazole, Ciprofloxacin and Minocycline with macrogol (M) as the ointment base and propylene glycol (P) as the carrier. The prime concern regarding the use of triple antibiotic paste is the discoloration caused by minocycline. To overcome this, alternative medications such as clindamycin, cefaclor, amoxycillin have been proposed. The American Association of Endodontists (AAE) 2018 protocol recommends Triple Antibiotics Paste (TAP) should be mixed equally (1:1:1) to a final concentration of 1 – 5 mg/ml. At this concentration, TAP is conducive with stem cell survival and proliferation and also effective in eliminating microorganisms within the root canal. But no standardization regarding the dosage of drugs used in the antibiotic combination of LSTR in deciduous teeth has been done till date. An in vivo interventional study will be conducted among children of age group 5-9 years with indication for pulp therapy using Modified Triple Antibiotic Paste (Ciprofloxacin, Metronidazole and Amoxicillin) with different concentrations (0.5 mg/ml, 2.5 mg/ml and 5 mg/ml) for LSTR of primary molars and comparative evaluation of clinical and radiographic success of LSTR will be done at specific time intervals. |