| CTRI Number |
CTRI/2022/12/048484 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison and Evaluation Of success of tricalcium silicate-based filling material,light-curable calcium hydroxide,and mineral trioxide aggregate as indirect pulp capping filling materials between deciduous (milk teeth) and permanent teeth. |
|
Scientific Title of Study
|
Evaluation Of the clinical and radiographic performance of tricalcium silicate-based material,light-curable calcium hydroxide,and mineral trioxide aggregate as indirect pulp capping materials between primary and permanent teeth:an in vivo 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 A SWARNALATHA |
| Designation |
PG student |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST ROAD CHINNA KOLAMBAKKAM PALAYANOOR (PO) CHENGALPATTU (DT)
Chennai
TAMIL NADU
603308
India |
| Phone |
8940929916 |
| Fax |
|
| Email |
dr.swarnalatha.bds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R VIGNESH GUPTHA |
| Designation |
Associate Professor |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST ROAD CHINNA KOLAMBAKKAM PALAYANOOR (PO) CHENGALPATTU (DT)
Chennai
TAMIL NADU
603308
India |
| Phone |
9840485769 |
| Fax |
|
| Email |
Vigneshguptha88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A SWARNALATHA |
| Designation |
PG student |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Karpaga Vinayaga Institute of Dental Sciences GST ROAD CHINNA KOLAMBAKKAM PALAYANOOR (PO) CHENGALPATTU (DT)
Chennai
TAMIL NADU
603308
India |
| Phone |
8940929916 |
| Fax |
|
| Email |
dr.swarnalatha.bds@gmail.com |
|
|
Source of Monetary or Material Support
|
| karpaga vinayaga institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
swarnalatha anbarasan |
| Address |
14/27 velachery road, alandur, chennai, tamilnadu 600016 |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| swarnalatha |
Karpaga vinayaga institute of dental sciences |
Department of Pedodontics and preventive dentistry,room no 8( 4th floor), Division of dental hospital,ROAD, CHINNA KOLAMBAKKAM,
PALAYANOOR (PO),
CHENGALPATTU (DT) 603 308
MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU |
8940929916
dr.swarnalatha.bds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - KIDS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Light cure calcium hydroxide
2. Mineral trioxide aggregate. |
Both these material are tooth filling material it is placed within the cavity and left permanently inside the cavity. (as a base for permanent restoration). |
| Intervention |
1. Tricalcium silicate based restorative cement. |
These Pulp capping filling material - is placed within the cavity and left permanently inside the cavity. (as a base for permanent restoration). |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Negative response to pain to palpation or percussion
2. remaining dentin thickness more than 0.25mm
3. periodontally sound teeth with large carious lesion
4. no history of spontaneous pain
5. more than 2/3rd of roots present |
|
| ExclusionCriteria |
| Details |
1. teeth with pulpal involvement
2. discolouration, mobility
3. pain or fistula
4.sign of physiological or internal root resorption greater than 1/3rd
5. pulpal calcification
6. periapical lesion |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluvate the clinical and radiographic success rate of three different indirect pulpcapping material |
1 month - 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluvate the clinical and radiographic success rate of three different indirect |
1 month - 6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2022 |
| Date of Study Completion (India) |
23/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical and Radiographic Evaluation of three Indirect Pulp Capping Materials This study aimed to assess the effectiveness of different materials used in indirect pulp capping and their impact on clinical and radiographic outcomes. The materials investigated included tricalcium silicate-based material (Biodentine), light-cured calcium hydroxide, and mineral trioxide aggregate (Endocem MTA). Background research highlighted the importance of exploring newer materials like light-curable calcium hydroxide, tricalcium silicate-based materials, and mineral trioxide aggregate (MTA) in preserving pulp vitality through indirect pulp capping procedures, both in primary and permanent teeth. The study involved 72 molar teeth, evenly split between primary and permanent teeth, with an age range of 4 to 8 years for primary teeth and 7 to 13 years for permanent teeth. Each tooth received one of the aforementioned materials followed by restoration with type 9 glass ionomer cement (GIC). Follow-up assessments were conducted at 1, 3, and 6 months, evaluating various parameters such as pain, vitality, restoration integrity, periodontal ligament (pdl) widening, radiolucency, and need for additional treatments. Statistical analysis was performed using the chi-square test. Results indicated no significant differences among the groups at 1 month, but significant disparities emerged during the 3-month follow-up period in both primary and permanent teeth groups. In primary teeth, MTA demonstrated a 100% success rate, followed by Biodentine and LC calcium hydroxide at 1, 3, and 6 months. Conversely, in permanent teeth, LC calcium hydroxide and Biodentine exhibited higher success rates compared to MTA. |