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
|
|
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
|
|
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 capsuleâ€, “a biocompatible and bioactive dentine substituteâ€. 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, sufï¬cient 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. |