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CTRI Number  CTRI/2018/02/012223 [Registered on: 28/02/2018] Trial Registered Retrospectively
Last Modified On: 27/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effect of three new materials for the treatment of deep cavities. 
Scientific Title of Study   Comparative evaluation of indirect pulp capping in young permanent teeth using three different materials : A randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bushra Rahman 
Designation  Post Graduate student, 1st year 
Affiliation  I.T.S Dental College , Hospital & Research Centre 
Address  I.T.S Dental College Hospital & Research Centre 47, Knowledge Park-3 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  8802135939  
Fax    
Email  bushrahmanjmi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mousumi Goswami 
Designation  HOD,Department of pediatric dentistry, I.T.S. dental college ,Hospital & Research Centre 
Affiliation  I.T.S Dental College Hospital & Research Centre  
Address  I.T.S Dental College Hospital & Research Centre Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  08588854190  
Fax    
Email  mousumi_leo@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mousumi Goswami 
Designation  HOD,Department of pediatric dentistry, I.T.S. dental college ,Hospital & Research Centre 
Affiliation  I.T.S Dental College Hospital & Research Centre  
Address  I.T.S Dental College Hospital & Research Centre Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  08588854190  
Fax    
Email  mousumi_leo@yahoo.co.in  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Bushra Rahman 
Address  I.T.S dental college , hospital & research centre 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
bushra rahman  I.T.S dental college , hospital & research centre 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bushra Rahman  i.t.s dental college and hospital, greater noida   I.T.S dental hospital, 47 knowledge park- III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
8802135939

bushrahmanjmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with deep dentinal caries ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biodentine  Tricalcium silicate, dicalcium silicate, calcium carbonate and oxide filler, iron oxide shade, and zirconium oxide. 
Intervention  Biodentine  Tricalcium silicate, dicalcium silicate, calcium carbonate and oxide filler, iron oxide shade, and zirconium oxide. 
Comparator Agent  Theracal LC  Light cured resin modified tricalcium silicate 
Intervention  Theracal LC  Light cured resin modified tricalcium silicate 
Comparator Agent  Three Mixtatin  Three Mixtatin-(100mg ciprofloxacin + 100 mg metronidazole +100 mg cefixime+ 2mg simvastatin) 
Intervention  Three Mixtatin  Three Mixtatin-(100mg ciprofloxacin + 100 mg metronidazole +100 mg cefixime+ 2mg simvastatin) 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
Clinically:
1.Patients with complete physical and mental wellbeing.
2.Permanent premolars and molars with deep dentinal caries.
3.Teeth with sensitivity to cold.
4.Positive pulp vitality on cold pulp testing
Radiographically
1.More than 70% or 2/3rd involvement of dentin thickness
2.Absence of periapical pathology.

EXCLUSION CRITERIA
Clinically:
1.History of spontaneous pain
2.Tenderness on palpation or percussion
3.Pathologic mobility of the tooth
4. Swelling of vestibule in relation to the tooth
5.Draining sinus tract in relation to the tooth.

Radiographically
1.Pathologic external/internal resorption
2.Furcation involvement
3.Calcifications within pulp
 
 
ExclusionCriteria 
Details  Clinically:
• History of spontaneous pain
• Tenderness on palpation or percussion
• Pathologic mobility of the tooth
• Swelling of vestibule in relation to the tooth
• Draining sinus tract in relation to the tooth.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
RESULT ANALYSIS CRITERIA
Clinical evaluation: Presence of
1.Sensitivity
2.Pain
3.Swelling
4.Sinus tract
Radiographic evaluation: Presence of
1.External or internal resorption of tooth
2.Pulp involvement
3.PDL widening
4.Periapical involvement
5.Young permanent teeth showing absence of root apex development
6. Pathologic external / internal root resorption
 
RESULT ANALYSIS CRITERIA
Clinical evaluation: Presence of
1.Sensitivity
2.Pain
3.Swelling
4.Sinus tract
Radiographic evaluation: Presence of
1.External or internal resorption of tooth
2.Pulp involvement
3.PDL widening
4.Periapical involvement
5.Young permanent teeth showing absence of root apex development
6. Pathologic external / internal root resorption
 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2016 
Date of Study Completion (India) 25/09/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary     The fundamental component of operative and endodontic treatment is to maintain the vitality of pulp so as to permit continued odontogenic development. Pulp tissue with its circulation keeps the dentine moist, resilient, and less brittle and also forms reparative dentine.

For a badly decayed tooth the discussion as to how much tissue must be removed in order to arrest the caries process is not new. In 1859 John Tomes  wrote “it is better that a layer of discolored dentine should be allowed to remain for the protection of the pulp rather than run the risk of sacrificing the tooth.” 

After caries exposure in a primary or permanent tooth, giving the pulp an opportunity to recover from the toxins of dental caries by judiciously removing the infected dentine and isolating the remaining carious lesion (i.e. affected dentine) from oral fluids with a restorative material is now an accepted treatment called as indirect pulp capping. Preserving a layer of affected dentine over pulpal roof protects the pulp from exposure and promotes the formation of tertiary dentine.

Calcium hydroxide since 1928 has been considered the gold standard and the most popular because of beneficial properties such as induction of mineralization, high pH and low cytotoxicity. However some of the limitations reported include poor bonding to dentine, dissolution over time, material reabsorption, mechanically weak, unstable, presence of tunnels in the dentine barrier and the handling properties are less than ideal.

Later MTA introduced by Torabinajed M in 1990 is used as a material of choice for all dentinal defects due to their biocompatibility and ability to induce calcium phosphate precipitate at the interface to periodontium and bone tissue repair, However there exists some drawbacks of this material such as slow setting kinetics and complicated handling properties.

Several new materials are introduced as pulp capping agents with better physical, chemical and biological properties. One such material is Biodentine, known as “dentine in capsule”, “a biocompatible and bioactive dentine substitute”. It attracted the attention in the field of dentistry due to fast setting time, high compatibility, high compressive strength, high pH( pH=12),excellent setting ability, and ease of handling as well as its versatile range of chemical applications in endodontics, dental traumatology, restorative dentistry and pediatric dentistry.

One of the recently developed light cure Mineral Trioxide Aggregate material is Theracal LC (Bisco). It is a new, resin-modified calcium silicate filled base/ liner material. The capability of Theracal LC to be cured to a depth of 1.7mm may avoid the risk of untimely dissolution. It has improved seal and bonds to keep the dentin moist. These properties offer major advantage in pulp capping.

Several antibiotics have also been proven beneficial in eradicating the microbial load in endodontics. One among them is combination of Ciprofloxacin, Metronidazole, and Minocycline known as triple antibiotic paste or 3 mix paste. It is capable of eliminating bacterial pathogens from infected dental tissues in both permanent and primary dentitions and  provides an excellent outcome in treatment of infected canals.

Statin components are emerging materials in regenerative dentistry. Evidence from both experimental and clinical studies supports the notion of ‘pleiotropic’ effects of statins. They improve osteoblast function and suppress function of osteoclast leading to enhanced bone formation. Therefore, they might improve odontoblastic function resulting in improved dentin formation. Statins are also thought to induce angiogenesis and increase neuronal cell. Consequently, they might have role in pulp regeneration along with dentin regeneration. In addition, sufficient evidence exists in support of the potent antiinflammatory properties of statins. They reduce circulating C-reactive protein (CRP) and pro-inflammatory cytokines levels. Therefore, statins can be considered as an ideal active ingredient in accelerating reparative dentin formation.

Thus the purpose of this study is to evaluate the effect of Biodentine, Thercal LC, and 3 Mixtatin as  indirect pulp capping agents in young permanent teeth.  

 
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