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CTRI Number  CTRI/2024/07/070225 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of clinical and radiographic success of three different pulp therapies in paediatric dental patients: A Randomized Controlled Clinical Study 
Scientific Title of Study   Comparative evaluation of clinical and radiographic success of lesion sterilization tissue repair (LSTR), modified LSTR with triple antibiotic paste and metapex pulpectomy in primary molars: a randomized controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayisha Beevi T P 
Designation  Junior Resident  
Affiliation  KGMU 
Address  4th floor, New Dental Building, Department of paediatric and preventive dentistry, Faculty Of Dental Sciences, King Georges Medical University, Chowk, Lucknow Uttar Pradesh -226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  09495785818  
Fax    
Email  drayishabeevitp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Afroz Alam Ansari 
Designation  Professor 
Affiliation  KGMU 
Address  4th floor, New Dental Building, Department of paediatric and preventive dentistry, Faculty Of Dental Sciences, King Georges Medical University,Chowk, Lucknow Uttar Pradesh -226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  09495785818  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayisha Beevi T P 
Designation  Junior Resident  
Affiliation  KGMU 
Address  4th floor, New Dental Building, Department of paediatric and preventive dentistry, Faculty Of Dental Sciences, King Georges Medical University,Chowk, Lucknow Uttar Pradesh -226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  09495785818  
Fax    
Email  drayishabeevitp@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King Georges Medical University Lucknow Uttar Pradesh- 226003 
 
Primary Sponsor  
Name  Ayisha Beevi T P 
Address  Junior resident FODS, Department of paediatric and preventive dentistry KGMU Lucknow Uttar pradesh - 226003 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ayisha Beevi T P  Lucknow  4th floor, New Dental Building, Department of paediatric and preventive dentistry, Faculty Of Dental Sciences, King Georges Medical University,Chowk, Lucknow Uttar Pradesh -226003
Lucknow
UTTAR PRADESH 
09495785818

drayishabeevitp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical Medical University U.P., Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LSTR  Only the coronal pulp will be removed and the pulp chamber half filled with modified 3Mix antibiotic paste, sealed with glass ionomer cement (GIC) and reinforced with stainless crown.  
Comparator Agent  Metapex pulpectomy  Both coronal as well as all radicular pulp tissue will be extirpated. Post biomechanical preparation and irrigation, root canals will be obturated with metapex material, sealed with GIC and reinforced with stainless crown. 
Intervention  modified LSTR  Both coronal as well as all accessible radicular pulp tissue will be extirpated and the access cavity half filled with modified 3Mix antibiotic paste, sealed with GIC and reinforced with stainless crown. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Nonvital primary posterior teeth with less than 2/3rd root resorption, with or without furcal radiolucency and bone loss are included in the study. 
 
ExclusionCriteria 
Details  allergic to any content of triple antibiotic paste
radiographic evidence of excessive external and internal resorption
non restorable tooth
primary teeth nearing exfoliation 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical success will be considered in the absence of pain, swelling, sinus tract or natural exfoliation of tooth.  Radiographic and clinical evaluation will be done at 3 month intervals for at least a 12 month period. 
 
Secondary Outcome  
Outcome  TimePoints 
patient satisfaction after the procedure  patient satisfaction is assessed immediately after the procedure, after 24 hours and 48 hours. 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   10/07/2024 
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)   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   INTRODUCTION 

Paediatric dentists come across with a number of cases with deep caries that has reached the periradicular tissues. Traditional treatment options for such teeth include extraction and conventional endodontic procedure i.e., pulpectomy. Although, extraction followed by placement of a space maintainer is a treatment option, preserving natural teeth in the arch is the better option. Successfully treated primary tooth is a superior space maintainer than an appliance. . To preserve pulpally involved primary tooth in the arch two techniques are indicated, conventional endodontic treatment i.e., pulpectomy and lesion sterilsation tissue repair (LSTR).

Pulpectomy has high success rate and can be used for the treatment of non vital tooth (abscessed, dead or dying) with no evidence of root resorption. According to AAPD guidelines pulpectomy is preferred over LSTR in tooth with no root resorption. LSTR is preferred over pulpectomy in teeth with root resorption. There are some recent researches which comparing the success of LSTR with pulpectomy irrespective of root resorption. These studies concluded that LSTR is better than pulpectomy. Removal of radicular pulp along with coronal pulp in LSTR procedure has better result than LSTR with removal of only coronal pulp.

 Therefore, this study has been designed to compare the clinical and radiographic success of LSTR, modified LSTR and pulpectomy.


Aim:

To find out best among the three techniques (LSTR, modified LSTR and pulpectomy)

METHODOLOGY:

Study Design: The present study will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, KGMU, Lucknow. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow.

Study Participants:

Patients within the age group 3 to 10 years, irrespective of gender and socioeconomic status will be enrolled in the study.

Inclusion criteria:

Non vital primary posterior teeth

Teeth with 1/3rd or <2/3 rd root resorption

Presence or absence of  furcal radiolucency

Severe bone loss and mobility

Parents not willing to extraction

Exclusion criteria:

Allergic to any contents of triple antibiotic paste

Radiographic evidence of excessive external and internal resorption

Primary teeth nearing exfoliation

Non restorable tooth


SAMPLE SIZE CALCULATION


Sample size estimation was done by using G Power software (version 3.0).  Sample size was estimated for Chi square test and Goodness of fit tests: Contingency tables was chosen.

A minimum total sample size of 61 was found to be sufficient for an alpha of 0.05, power of 80%, 0.4 as effect size (anticipated moderate effect size) and 2 as degrees of freedom. 

This sample size is rounded off to 63 (21 per group).


Procedure:

 Informed consent will be obtained from parents. All participants will be screened by taking detailed history and performing thorough clinical and radiographic examination. Based on the inclusion and exclusion criteria, all selected primary teeth shall be randomly divided into three groups depending on the type of technique used.

Group I: Pulpectomy with metapex

Group II: Only the coronal pulp will be removed and the pulp chamber half filled with modified 3Mix antibiotic paste, sealed with glass ionomer cement (GIC) and reinforced with stainless crown.

Group III: Both coronal as well as all accessible radicular pulp tissue will be extirpated and the medication cavity half�’filled with modified 3Mix antibiotic paste, sealed with GIC and reinforced with stainless crown.

      Isolation of the operating field with rubber dam will be done. Radiographic and clinical evaluation will be done at 3 month intervals for at least a 12 month period.

Evaluation of outcome:

Clinical evaluation:

Resolution or improvement of clinical symptoms will be checked after treatment. Clinical success will be considered in the absence of pain, swelling, sinus tract or natural exfoliation of teeth.

Radiographic evaluation

Radiographic success will include absence, decrease or disappearance of initial radiolucent area, and no new radiolucency.

Ø  Data collection method

            The data for each tooth will be recorded on individual data record sheet. The final data will be transferred to master data sheet. The data thus obtained will be subjected to to statistical analysis.

Statistical analysis:

Data will be analysed using Statistical Package for Social Sciences (SPSS) version 21. As outcome measures are categorical in nature, thus, will be summarized as absolute and relative frequencies. The intergroup comparison of outcome measures will be done using chi square test. The level of statistical significance will be set at 0.05.

                                                                                                                                                                                                                                                                        







 
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