FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069664 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dentin bridge formation and resolution of pain comparing two different medicated agents for dental filling 
Scientific Title of Study   Cone Beam Computed Tomographic evaluation of dentin bridge formation using Mineral Trioxide Aggregate with Melatonin and Freeze Dried Amniotic Membrane for Direct Pulp Capping in permanent Molars A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPraveena Sharma 
Designation  Reader 
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Dept of Conservative Dentistry and Endodontics, Subbaiah Institute of Dental Sciences NH13 Purle Shivamogga

Shimoga
KARNATAKA
577202
India 
Phone  7899862846  
Fax    
Email  praveenasharma89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPraveena Sharma 
Designation  Reader 
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Dept of Conservative Dentistry and Endodontics, Subbaiah Institute of Dental Sciences NH13 Purle Shivamogga

Shimoga
KARNATAKA
577202
India 
Phone  7899862846  
Fax    
Email  praveenasharma89@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPraveena Sharma 
Designation  Reader 
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Dept of Conservative Dentistry and Endodontics, Subbaiah Institute of Dental Sciences NH13 Purle Shivamogga

Shimoga
KARNATAKA
577202
India 
Phone  7899862846  
Fax    
Email  praveenasharma89@gmail.com  
 
Source of Monetary or Material Support  
Subbaiah Institute of Dental Sciences, NH13, Purle, Shivamogga, Karnataka, India Pincode-577202  
 
Primary Sponsor  
Name  Subbaiah Institute of Dental Sciences NH Purle Shivamogga Karnataka India 
Address  NH 13, Purle, Shivamogga, Karnataka , India 
Type of Sponsor  Research institution and hospital 
 
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 Praveena Sharma  Subbaiah Institute of Dental Sciences   Dept of Conservative Dentistry and Endodontics Room no 4 Subbaiah Institute of Dental Sciences NH13 Purle Shivamogga Karnataka India
Shimoga
KARNATAKA 		 7899862846

praveenasharma89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Subbaiah Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mineral trioxide aggregate (MTA)  Mineral trioxide aggregate (MTA) which is a calcium silicate based pulp capping agent Group 1- mineral trioxide aggregate alone used as a direct pulp capping agent  
Intervention  Mineral Trioxide Aggregate (MTA) and Freeze dried amniotic membrane   Group 3: MTA is to be placed directly over customised and sterile freeze dried amniotic membrane as a direct pulp capping agent Dose: 1.5 mm thickness of MTA Frequency: one time application Route of administration: directly placed intra orally on the floor of the prepared cavity Total duration: 4 weeks  
Intervention  Mineral Trioxide Aggregate(MTA) and Melatonin   Group2 : MTA with 3 mg freshly powdered Melatonin tablet mixed in a 1:1 ratio and used as a direct plulp capping agent Frequecy: one time application Dose: 3 mg melatonin + MTA mixed in a ratio of 1:1 with sterile water Route of administration: direct application intra orally in the prepared cavity to a thickness of 1.5 mm Total duration: 4 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients with class 1 deep carious lesion in mandibular first and second molar
Teeth with vital pulp, mature apex 
 
ExclusionCriteria 
Details  Patients with habit of tobacco chewing and smoking
Pregnant and lactating mothers
Diabetic patients
Teeth with immature apex, periapical pathosis
Teeth with irreversible pulpitis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dentin bridge formation in the compared groups evaluated with the help of intra oral periapical radiograph (IOPAR) and Cone Beam Computed Tomography (CBCT)
 		 Baseline response before starting the procedure, immediately after treatment, 3 months, 6months, 9months and 12 months after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Resolution of signs and symptoms clinically and radiographically
Resolution of pain assessed with help of pain scale 		 3,6,9,12 months 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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 2 
Date of First Enrollment (India)   18/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The vitality of the pulp is essential for the protection of the tooth structure and the maintenance of proper physiological function. Following pulp exposure and Direct Pulp Capping, early changes include hemorrhage and moderate inflammation, resolved during the first week [1] In turn, this might also provide a conducive environment for the formation of reparative dentin if the bacterial irritation and inflammatory reaction are successfully mitigated. The release of calcium ions from the DPC biomaterials stimulates the precipitation of calcium carbonate in the wound area and thereby contributes to the initiation of mineralization. After placing Mineral Trioxide Aggregate (MTA) material over the exposed pulp, MTA activates the progenitor cells (fibroblast) migration from the central pulp to the exposure area. This helps to promote their proliferation and differentiation into odontoblast-like cells without inducing apoptosis in the pulp cells [2]. MTA induces a time-dependent environment that is proinflammatory and promotes wound regeneration through upregulation of cytokines [3]. Cytokine upregulation is responsible for the induction of biomineralization by the production of collagen fibrils or apatite-like clusters at the dentin-MTA interface. MTA releases calcium ions which exert antibacterial effects and promote mineralization beneath the pulp exposure area and has the potential to maintain the vitality of the pulp [4]. Previosly melatonin given orally in animal studies have shown to have similar effects such as MTA. Human Amniotic Membrane has also shown healing of inflammed pulp when placed direcly on exposed pulp.[5,6,7]
References:
1) ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium hydroxide paste, mineral trioxide aggregate, and formocresol as direct pulp capping agents in primary molars: A randomized controlled clinical trial. Pediatr Dent 2022;44(6):411-5.E14-E15.
2) Bui AH, Pham KV. Evaluation of reparative dentine bridge formation after direct pulp capping with biodentine. Int Soc Prevent Communit Dent 2021;11:77-82.
3) Reyes-Carmona JF, Santos AS, Figueiredo CP, Baggio CH, Felippe MC, Felippe WT, et al. Host–mineral trioxide aggregate inflammatory molecular signaling and biomineralization ability. J Endod 2010;36:1347–53.
4) Kunert M, Lukomska-Szymanska M. Bio-inductive materials in direct and indirect pulp capping—a review article. Mater 2020;13:1204.
5) Johri S, Verma P, Bains R,Human amniotic membrane as therapeutic agent in pulpotomy of permanent molars. BMJ Case Rep 2021;14:e243414.
6) Amniotic Membrane versus Formocresol as Pulpotomy Agents in Human  Primary Molars: An in vivo Study Pesquisa Brasileira em Odontopediatria e Clinica Integrada 2017, 17(1):e3794
7) Julia Guerrero-Gironés, Antonia Alcaina-Lorente, Clara Ortiz-Ruiz, Eduardo Ortiz-Ruiz. Melatonin as an Agent for Direct Pulp-Capping Treatment. Int. J. Environ. Res. Public Health 2020, 17, 1043.
8) Keskin Åž, Åžengül F, Åžirin B. Evaluating the cytotoxic effect of melatonin and oxyresveratrol on dental pulp stem cells. Eurasian J Med (2023);55(1):32-36.
9) Rafiqul islam, Md refat readul islam, tora tanaka. Direct pul capping procedures - evidence and practice. Jpn Dent Sci Rev, 2023 Dec, 59:48-61.
10) Cobanoglu N, Alptekin T, Kitagawa H, Blatz MB, Imazato S, Ozer F. Evaluation of human pulp tissue response following direct pulp capping with a self-etching adhesive system containing MDPB. Dent Mater J 2021;40:689–96.

 

 
Close