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CTRI Number  CTRI/2024/08/073092 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 24/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparision of three different root canal filling material in primary teeth- A clinical study 
Scientific Title of Study   Comparative evaluation of clinical and radiographic success of three different obturating materials in primary mandibular 2nd molars. 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  Dr Keerthana V 
Designation  PG Student 
Affiliation  Adhiparasakthi dental college and hospital Melmaruvathur-603319 
Address  Room No-6, First floor, Department of Pediatric and Preventive Dentistry, Melmaruvathur, Kanchipuram

Kancheepuram
TAMIL NADU
603319
India 
Phone  8610734275  
Fax    
Email  keerthanav191@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Selvabalaji 
Designation  Reader 
Affiliation  Adhiparasakthi dental college and hospital Melmaruvathur-603319 
Address  Room No-6, First floor, Department of Pediatric and Preventive Dentistry, Melmaruvathur, Kanchipuram

Kancheepuram
TAMIL NADU
603319
India 
Phone  9003604774  
Fax    
Email  selvabalaji88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A Selvabalaji 
Designation  Reader 
Affiliation  Adhiparasakthi dental college and hospital Melmaruvathur-603319 
Address  Room No-6, First floor, Department of Pediatric and Preventive Dentistry, Melmaruvathur, Kanchipuram

Kancheepuram
TAMIL NADU
603319
India 
Phone  9003604774  
Fax    
Email  selvabalaji88@gmail.com  
 
Source of Monetary or Material Support  
Dental OPD in Adhiparasakthi Dental College and Hospital and Dental camps Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melamruvathur-603319, Tamilnadu, India. 
 
Primary Sponsor  
Name  Dr Keerthana V 
Address  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur-603319 
Type of Sponsor  Other [(Self)] 
 
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 Keerthana V  Adhiparasakthi dental college and hospital  Room no:6, first floor, Department of Pediatric and Preventive dentistry, Melmaruvathur-603319.
Kancheepuram
TAMIL NADU 
8610734275

keerthanav191@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board- Adhiparasakthi Dental College and Hospital  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  Endoflas  To assess the radiographic infectious process, resolve in 6 months evidenced by bone deposition in the pretreatment radiolucent areas and to assess the pretreatment clinical signs and symptoms should resolve within a few weeks. The participants will be followed at 1 month, 3 months and 6 months.  
Intervention  Rc fill, and Zinc Oxide Powder with 10% Sodium Fluoride  To comparatively evaluate clinical and radiographic success of three obturating materials in mandibular 2nd primary molars and to assess the radiographic infectious process resolve in 6 months evidenced by bone deposition in the pretreatment radiolucent areas. The participants will be followed at 1 month, 3 months and 6 months. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Dental caries with intra-oral and/or extraoral swelling or draining sinus tract
2.Dental caries with irreversible pulpitis
3.Dental caries with inter-radicular or periapical radiolucency.
4.Teeth with two-thirds of root length intact.
5.Patient/ Parent willing for the treatment
 
 
ExclusionCriteria 
Details  1.Presence of resorption in root (external or internal).
2.Teeth with pulpal floor perforation.
3.Teeth with pathologic/ pre shedding mobility.
4.H/0 allergic to LA or to the components of the test materials.
5.Presence of medically compromising systemic conditions.
6.Teeth with less than 2/3rd of root length.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes are clinical and radiographic evaluations used to determine the effects of the interventions. All cause morbidity at 6 months. Success rate of pulpectomy defined as absence of clinical symptoms and radiographic signs of pathology at 6 months.  At baseline, 1 month, 3 months, and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
All cause morbidity at 1, 3,6 months. Incidence of post-operative pain, Incidence of post-operative infection, Radiographic evidence of root resorption  at baseline, 1 month, 3 months, 6months. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   10/10/2024 
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="1"
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:

               Pulpectomy is a root canal procedure for pulp tissue that is irreversibly infected or necrotic due to caries or trauma. The root canals are debrided, disinfected and filled with resorbable material (AAPD 2015). Treatment objective of pulpectomy is to maintain the tooth free of infection contamination, biomechanically cleanse and obturate the basis canals, promote physiologic root resorption. Obturated teeth is then restored with a restoration to prevent microleakage, aid in healing and sustained health of the peri-radicular tissue. But there is a difficulty in obturating primary root canals as Zinc oxide-eugenol pastes sets to hard mass and Metapex shows hallow tube effect. These materials have been traditionally used for a long time but cannot be said to be ideal. (Gurlal Singh Brar et.,) Now, various new materials have been introduced to overcome the drawbacks of ideal material, which lead to the search for friendlier root filling resorbable pastes.

 

OBJECTIVES:

To comparatively evaluate clinical and radiographic success of three obturating materials in mandibular 2nd primary molars- RC FILL, ENDOFLAS, and ZINC OXIDE POWDER WITH 10% SODIUM FLUORIDE.

To assess the radiographic infectious process resolve in six months evidenced by bone deposition in the pretreatment radiolucent areas.

To assess the pretreatment clinical signs and symptoms should resolve within a few weeks.

SAMPLE SIZE:

60 Primary mandibular 2nd molars.

Age group – 4 to 9 years old

SOURCE OF SAMPLE TO BE TAKEN:

ü  Outpatients from the Department of Pediatric and Preventive dentistry, Pediatric dental outPatients in medical college, school dental camps.

 

MATERIALS:

Samples Divided into 3 groups as;

Group 1- Rc fill (20 numbers)

Group 2- Endoflas (20 numbers)

Group 3- Zinc oxide-10% sodium fluoride (20 numbers)

 INCLUSION CRITERIA

  1. Dental caries with intra-oral and/or extraoral swelling or draining sinus tract
  2. Dental caries with irreversible pulpitis
  3. Dental caries with inter-radicular or periapical radiolucency.
  4. Teeth with two-thirds of root length intact.
  5. Patient/ Parent willing for the treatment

 

 EXCLUSION CRITERIA

  1. Presence of resorption in root (external or internal).
  2. Teeth with pulpal floor perforation.
  3. Teeth with pathologic/ pre shedding mobility.
  4. H/0 allergic to LA or to the components of the test materials.
  5. Presence of medically compromising systemic conditions.
  6. Teeth with less than 2/3rd of root length.

 

 METHODOLOGY:

·        The study will adhere to ethical guidelines and has been approved by an institutional ethics committee. Patient confidentiality will be maintained throughout the study.

·       Detailed informed consent will be obtained from parents, including explanations of the study purpose, procedures, risks, and benefits.

·       Consent will be documented using signed forms. Local anesthesia with 2% lignocaine and 1:80,000 adrenaline (Lignox 2% Indoco) will be administered using standard infiltration techniques.

·       Rubber dam will be placed using a standard technique to ensure isolation. Access cavity will be created with a #6 round bur at a high speed under water cooling. Necrotic pulp will be removed using a sharp spoon excavator. The chamber will be irrigated with saline. The pulp chamber will be deroofed with a non-end cutting bur. Pulp tissue will be extirpated using a barbed broach and a #15 K-file. Canal patency will be checked, and working length will be determined using radiographs and an apex locator.

·       KEDO NANO-PLUS rotary files will be used for biomechanical preparation (BMP) to the working length, following manufacturer guidelines.

·       For obturation, RC Fill (Prime) will be applied with a lentulo spiral in Group I.

·       Endoflas will be placed incrementally and condensed with a hand plugger in Group II.

·       Zinc Oxide powder with 10% sodium fluoride will be mixed and placed with lentulo spirals in Group III.

·       Post-op radiographs will be taken to verify obturation quality. Entrance restoration will be done with type IX GIC cement. Stainless Steel Crown (SSC) will be placed once obturation is satisfactory.

·       The evaluator and outcome assessor will be blinded to the group allocations. Clinical and radiographic evaluations will be conducted immediately post-op and at 1, 3, and 6-month intervals using predefined criteria (Gupta and Das, 2011; Coll and Sadrian).

·       Data will be collected on standardized forms and entered into a secure database. Statistical analysis will be done using SPSS software. Outcomes between groups will be compared using the Chi-square test, with a significance level set at 5% (p<0.05). Descriptive statistics (mean and standard deviation) will be calculated. To compare differences between three groups, we will use REPEATED MEASURES ANOVA or the KRUSKAL-WALLIS test, depending on the normality of the data distribution.

 

REFERENCES:

1.     Elicherla SR, Bandi S, Saikiran KV, Nunna M, Sahiti PS, Nuvvula S. The clinical and radiographic success of Endoflas compared with other root canal obturating materials in primary teeth: A systematic review. Dent Res J 2022;19:72

2.   Pramila R, Muthu MS, Deepa G, Farzan JM, Rodrigues SJ. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Int Endod J. 2016 May;49(5):413-21. doi: 10.1111/iej.12478. Epub 2015 Jul 4. PMID: 26059708

3.     Clinical and radiographic evaluation of four different zinc-oxide integrated root canal obturating materials used in primary teeth Himani Goel, Shivani Mathur, Vinod SachdevAvailable online at www.sciencedirect.com Pediatric Dental Journal journal homepage: www.elsevier.com/locate/pdj pediatric dental journal xxx (2018) 1 e1 4 https://doi.org/10.1016/j.pdj.2018.06.002

4.     Goel H, Mathur S, Sachdev V. Evaluation of a mixture of zinc oxide–10% sodium fluoride as novel root canal filling material: Apilot study!! J Indian Soc Pedod Prev Dent 2019;37:392-8

 
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