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CTRI Number  CTRI/2024/07/070985 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Study of Inflammation in Gum Fluid After Using Two Dental Treatments for Severe Tooth Pain 
Scientific Title of Study   Comparative evaluation of inflammatory biomarkers in gingival crevicular fluid after Mineral Trioxide Aggregate and Biodentine pulpotomy in teeth with Symptomatic Irreversible Pulpitis: An Open label 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  Dr Ranjana Hanumant Deshmukh 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences ,Nagpur 
Address  Room no. 407,OPD Building ,4TH floor, Department of Dentistry, All India Institute Of Medical Sciences,Mihan,Dahegaon,Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9822621360  
Fax    
Email  ranjanadeshmukh17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Neelam Bajaj 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences ,Nagpur 
Address  Room no. 407,OPD Building ,4TH floor, Department of Dentistry, All India Institute Of Medical Sciences,Mihan,Dahegaon,Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9323218572  
Fax    
Email  drneelamch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ranjana Hanumant Deshmukh 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences ,Nagpur 
Address  Room no. 407,OPD Building ,4TH floor, Department of Dentistry, All India Institute Of Medical Sciences,Mihan,Dahegaon,Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9822621360  
Fax    
Email  ranjanadeshmukh17@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences,Dahegaon,MIHAN,Nagpur.PINCODE:441108 
 
Primary Sponsor  
Name  Dr Ranjana Hanumant Deshmukh 
Address  Room no. 407,OPD Building ,4TH floor, Department of Dentistry, All India Institute Of Medical Sciences,Mihan,Dahegaon,Nagpur  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Ranjana Hanumant Deshmukh  All India Institute of Medical Sciences,Nagpur  Room no. 407,OPD Building ,4TH floor, Department of Dentistry, All India Institute Of Medical Sciences,Mihan,Dahegaon,Nagpur
Nagpur
MAHARASHTRA 		 9822621360

ranjanadeshmukh17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Department of Pharmacology,AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Symptomatic Irreversible Pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  pulpotomy using biodentine as a pulpotomy agent  second group will be intervened by biodentine as a pulpotomy agent ,outcome is assessed by change in inflammatory marker levels after 7 days and clinically and radiographically assessed for 3,6 and 12 month for absence of any clinical symptoms and signs and radiographically for absence of any radiographic pathology. . 
Comparator Agent  pulpotomy using mineral trioxide aggregate as a pulpotomy agent  one group will be intervened by mineral trioxide aggregate as a pulpotomy agent ,outcome is assessed by change in inflammatory marker levels after 7 days and clinically and radiographically assessed for 3,6 and 12 month for absence of any clinical symptoms and signs and radiographically for absence of any radiographic pathology. . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient age 18 -60 years.Non contributory medical history (ASA1),Deep caries extending to pulp chamber.Vital mature first mandibular molar with symptoms of irreversible pulpitis.Tooth with positive response to pulp sensibility testing. Clinical diagnosis of irreversible pulpitis with PAI score≤2.Tooth should be restorable.Tooth with probing pocket depth and mobility should be within normal limits.

 
 
ExclusionCriteria 
Details  Teeth with immature roots.Teeth with clinical sign of pulp necrosis such as swelling or presence of sinus tract .Teeth with prominent radiolucency in the furcation area, presence of internal or external root resorption, any calcification.Teeth with no evidence of bleeding after communication with pulp chamber. Absence of antagonist tooth.
Had taken analgesic in past 3 days or antibiotic in past one month.Tooth with periapical lesion visible on radiograph. Teeth in which hemostasis was not achieved in 10 min.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
primary outcome : evaluate change in inflammatory marker before and after pulpotomy
 		 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
secondary Outcome assessment criteria to be performed every 3, 6 and 12 months :
Clinical criteria:
1. Post operative pain assessment using VAS after 24, 48, 72 hours and 7 days.
2. No history of spontaneous pain or discomfort except for the first 2 days after treatment
3. No tenderness to palpation or percussion and the tooth is functional
4. Normal mobility and probing pocket depth
5. Soft tissues around the tooth are normal with no swelling or sinus tract

Radiographic criteria:
1. No pathosis evident on the radiograph such as periapucal widening, root resorption, furcal pathosis or new periapical pathosis .
 		 12 months 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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/ Phase 3 
Date of First Enrollment (India)   23/07/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included ranjanadeshmukh17@gmail.com).

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 31-03-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

SUMMARY

TITLE OF THE STUDY:

“Comparative evaluation of inflammatory biomarkers in gingival crevicular fluid after Mineral Trioxide Aggregate and Biodentine pulpotomy in teeth with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial”.

Traditionally , The clinical diagnosis of pulp status  is based on clinical signs and symptoms, the extent of adjacent caries, responses to pulp testing and percussion, and the radiographic presentation of the periapical tissues at the root apex.

However various studies have concluded that there is insufficient evidence to determine whether the symptoms offer accurate information about the extent of pulp inflammation. Also the inflammatory changes in teeth exhibiting these symptoms are frequently limited to the pulp next to carious lesions, while the majority of the pulp tissue remains uninflamed and viable .

As a result its critical diagnosis becomes difficult.

Biological markers in pulp and surrounding tissue like gingival crevicular fluid  serves as a diagnostic biomarker for inflammation.

Pulpotomy is being preferred as a minimally invasive treatment over traditional RCT. (sustaining vitality, neurosensory capacity and proprioception , less time consumable , less difficult & less expensive) as it incorporates the use of  dental biomaterials ( MTA  and Biodentine) that preserves pulpal vitality and encourages healing.

There is lack of evidence in assessment of inflammatory markers in pulpotomy treatment for teeth diagnosed with symptomatic irreversible pulpitis.

 Therefore this randomized controlled trial is proposed to asses the changes in inflammatory markers in gingival crevicular fluid after pulpotomy in mature permanent teeth present with diagnosis of SIP.

 

 

AIMS AND OBJECTIVES:

AIM:

To compare the changes in the level of inflammatory biomarkers IL-8, TNF-a ,MMP-9  in gingival crevicular fluid (GCF) before & after MTA & BIODENTINE pulpotomy  in teeth with symptomatic irreversible pulpitis.

 

OBJECTIVES:

Primary objective: To asses the changes in the inflammatory markers in gingival crevicular fluid (GCF) before and after MTA and Biodentine Pulpotomy.

Secondary objective:

Determine the 12 months clinical and radiographic outcome after MTA and BIODENTINE pulpotomy in teeth with symptomatic irreversible pulpitis.

 
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