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CTRI Number  CTRI/2023/02/049408 [Registered on: 02/02/2023] Trial Registered Prospectively
Last Modified On: 01/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Inflammatory Biomarker Based validation of Evidence for Vital Pulp Therapy as Alternative to Root Canal Treatment for advanced Dental Caries 
Scientific Title of Study   Inflammatory Biomarker Based Substantiation of Evidence for Performance of Vital Pulp Therapy as Potential Alternative to Endodontic Treatment using Quantitative light-induced Fluorescence Guided Caries Removal for Management of Symptomatic Carious Mature Teeth (Extremely Deep/Deep Carious Lesion)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchika Roongta Nawal 
Designation  Professor 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Third floor, Department of Conservative Dentistry and Endodontics, Maulana Azad Institute of Dental Sciences, New Delhi

Central
DELHI
110002
India 
Phone  9582948894  
Fax    
Email  ruchika.roongta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ruchika Roongta Nawal 
Designation  Professor 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Third floor, Department of Conservative Dentistry and Endodontics, Maulana Azad Institute of Dental Sciences, New Delhi

Central
DELHI
110002
India 
Phone  9582948894  
Fax    
Email  ruchika.roongta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudha Yadav 
Designation  Senior Research Associate 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Third floor, Department of Conservative Dentistry and Endodontics, Maulana Azad Institute of Dental Sciences, New Delhi

Central
DELHI
110002
India 
Phone  8010629600  
Fax    
Email  sudhayadav2788@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Institute of Dental Sciences, New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Institute of Dental Sciences, New Delhi 
Address  MAMC Complex, Bahadur Zafar Marg, New Delhi, 110002 
Type of Sponsor  Government medical college 
 
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 Ruchika Roongta Nawal  Department of Conservative Dentistry & Endodontics, Maulana Azad Institute of Dental Sciences  Third floor, Maulana Azad Institute of Dental Sciences, New Delhi, 110002
Central
DELHI 
9582948894

ruchika.roongta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAIDS Institutional Ethical Commitee  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  Non QLF guided vital pulp therapy  In the comparator group, carious removal will be done using traditional method with burs and spoon excavator. Partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed. Approximately 2-3 mm or more of pulpal tissue underneath the exposure site will be removed (for partial pulpotomy) or the pulp tissue will be removed till the level of canal orifices (for full pulpotomy), using a sterile high-speed round bur. 2.5-3% sodium hypochlorite will be used for the irrigation of pulpal tissue, and the bleeding will be controlled with 2.5-3% sodium hypochlorite-moistened cotton pellets. If the bleeding cannot be controlled within 10 minutes even after performing full pulpotomy, the treated tooth will be excluded from the study and further treated by RCT. Inflammatory biomarker analysis: 100µL of pulpal blood sample will be collected from all the patients using micropipette after pulpal exposure. The pulpal blood samples will be transferred to numbered Eppendorf cups (e-cups) , it will be centrifuged at 1.000 x g for 1 min and stored at -80ºC until laboratory processing. Level of inflammatory biomarkers will be assessed using multiplex assay and expressed in assessed in pg/mL. Biodentine will be placed in the cavity and gently packed using a condenser. After 2 weeks, a resin composite restoration will be done. After completing the restoration, a periapical radiograph will be recorded to serve as a baseline for future evaluation. All the treatment procedure will be done by experienced endodontists under dental operating microscope using enhance treatment protocol recommended by European society of Endodontists (ESE).  
Intervention  QLF Guided Vital pulp Therapy  In the intervention group. After caries removal with burs, prepared cavity will be scanned with Quantitative light induced fluorescence (QLF) device. The infected dentin indicated by QLF analysis will be further removed. Complete removal of infected dentin will be ensured by scanning prepared cavity again before pulpal exposure. Partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed. Approximately 2-3 mm or more of pulpal tissue underneath the exposure site will be removed (for partial pulpotomy) or the pulp tissue will be removed till the level of canal orifices (for full pulpotomy), using a sterile high-speed round bur. 2.5-3% sodium hypochlorite will be used for the irrigation of pulpal tissue, and the bleeding will be controlled with 2.5-3% sodium hypochlorite-moistened cotton pellets. If the bleeding cannot be controlled within 10 minutes even after performing full pulpotomy, the treated tooth will be excluded from the study and further treated by RCT. Inflammatory biomarker analysis: 100µL of pulpal blood sample will be collected from all the patients using micropipette after pulpal exposure. The pulpal blood samples will be transferred to numbered Eppendorf cups (e-cups) , it will be centrifuged at 1.000 x g for 1 min and stored at -80ºC until laboratory processing. Level of inflammatory biomarkers will be assessed using multiplex assay and expressed in assessed in pg/mL. Biodentine will be placed in the cavity and gently packed using a condenser. After 2 weeks, a resin composite restoration will be done. After completing the restoration, a periapical radiograph will be recorded to serve as a baseline for future evaluation. The impact of QLF guided caries removal on the outcome of vital pulp therapy will be noted in the follow up visits.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Clinical inclusion criteria:
The age of the patient should be 18 or above
Patient should have non-contributory medical history
Symptomatic permanent mature posterior tooth with deep or extremely deep Class I/II caries with symptoms indicative of irreversible pulpitis
History of Moderate to severe pain
History of spontaneous pain and/or nocturnal pain which aggravates on lying down.
Patient reporting with spontaneous pain and/or with sharp and lingering pain upon
cold testing using Endo-Ice and early exaggerated response with electric pulp testing.
A restorable tooth with probing pocket depth (<3mm) and mobility within normal limits.
Complete caries removal will result in pulpal exposure.
Pulpal bleeding can be arrested with 2.5-3% NaOCl irrigation within 10 minutes after
inflamed pulp amputation.

Radiological inclusion criteria:
Deep or Extremely deep caries
Absence of periapical or furcation changes in the radiograph. 
 
ExclusionCriteria 
Details  Clinical exclusion criteria:

Tooth having unexposed pulp after complete caries removal.
Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.
Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.
Tooth showing negative response to cold testing or presence of sinus tract or swelling.

Radiological exclusion criteria:
Prominent radiolucency at the furcation or periapical regions
Presence of apical resorption
Presence of internal or pathologic external root resorption, calcification, or pulp canal
obliteration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and Radiographic success of Vital pulp Treatment at minimum one year follow up

Post operative pain
correlation between Inflammatory markers and pre operative diagnosis
 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain assessed using visual analog scale  i,3,7,14 days 
Association between level of inflammatory mediators in Pulpal Blood and treatment outcome  12 months 
Correlation between level of inflammatory mediators in pulpal blood and preoperative diagnosis  12 months  
Effect of Vital pulp treatment on Oral Health Related Quality of Life  12 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   04/02/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Researchers who provide a methodologically sound proposal.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ruchika.roongta@gmail.com].

  6. For how long will this data be available start date provided 25-01-2025 and end date provided 25-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Dental caries affects nearly 3.5 billion people globally. As most patients report in advanced stage, 70% of them need root canal treatment (RCT) for caries management. However, RCT is a destructive procedure resulting in complete removal of vital tissues of the tooth. Vital Pulp Therapy (VPT) has merged as an economical and conservative alternative to RCT. However, at present the main deterrent for VPT to be considered as first line of treatment for carious teeth is lack of high-quality evidence and objective criteria for case selection. Hence, the aim of this prospective clinical study is to evaluate the outcome of vital pulp therapy procedure in symptomatic cariously exposed posterior teeth with Quantitative Light-induced Fluorescence (QLF) assisted caries removal and correlate the level of locally expressed inflammatory biomarkers in pulpal blood with the treatment outcome. The proposed study shall be conducted in the Department of Conservative Dentistry & Endodontics, at Maulana Azad Institute of Dental Sciences, New Delhi on 120 patients referred to the department for the management of their symptomatic carious permanent molar teeth. Informed consent will be obtained from all patients prior to treatment followed by taking history.  Patient will be randomly allocated to QLF or Non QLF group. All the treatment procedure will be done by experienced endodontists under dental operating microscope using enhance treatment protocol recommended by European society of Endodontists (ESE). The cavity will be prepared using a sterile high-speed round bur, whereas carious removal will be performed using a slow-speed round bur and a spoon excavator. After caries removal, prepared cavity will be scanned with QLF in QLF group. The infected dentin indicated by QLF analysis will be further removed. Complete removal of infected dentin will be ensured by scanning prepared cavity again before pulpal exposure. In both the Experimental groups, partial pulpotomy will be attempted first. If bleeding cannot be arrested even after 10 minute using 2.5-3% Sodium hypochlorite, full pulpotomy will be performed. Patient will be regularly followed up for post operative pain assessment (1,3,7,14 days), clinical and radiographic treatment outcome (Minimum 1 year follow up).

 
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