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CTRI Number  CTRI/2022/03/041298 [Registered on: 23/03/2022] Trial Registered Prospectively
Last Modified On: 03/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to check the results of two procedures for the inflammation of tooth pulp in which, one of the procedure involves half of the root canal procedure and the other one without root canal procedure 
Scientific Title of Study   A STUDY TO ASSESS THE OUTCOME OF COMBINATION OF NON-SURGICAL ENDODONTIC THERAPY AND VITAL PULP THERAPY IN COMPARISON TO FULL PULPOTOMY PERFORMED IN MATURE PERMANENT MANDIBULAR MOLAR TEETH WITH SYMPTOMATIC IRREVERSIBLE PULPITIS AND PERIAPICAL RAREFACTION- A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aakash 
Designation  Junior Resident Academic 
Affiliation  All india institute of medical sciences, New delhi 
Address  3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110019
India 
Phone  9319018101  
Fax  91-11-26588663  
Email  aakashsahai00007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Chawla 
Designation  Additional Professor 
Affiliation  All india institute of medical sciences, New delhi 
Address  3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110019
India 
Phone  9871445522  
Fax  91-11-26588663  
Email  dr.amritachawla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aakash 
Designation  Junior Resident Academic 
Affiliation  All india institute of medical sciences, New delhi 
Address  3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
3rd floor, Centre of Dental Education and Research, All india institute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110019
India 
Phone  9319018101  
Fax  91-11-26588663  
Email  aakashsahai00007@gmail.com  
 
Source of Monetary or Material Support  
All india institute of medical sciences new delhi 
 
Primary Sponsor  
Name  All india institute of medical sciences  
Address  All india institute of medical sciences, new delhi, 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 Aakash Sahai  dept of conservative dentistry and endodontics, CDER AIIMS, new delhi  3rd floor CDER AIIMS new delhi
South West
DELHI 		 9319018101
91-11-26588663
aakashsahai00007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTEE FOR GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  endovital:-Combination of non-surgical endodontic therapy and vital pulp therapy  Combination of non-surgical endodontic therapy and vital pulp therapy: The patient will be requested to rinse the oral cavity with 10 ml. of 0.2% chlorhexidine digluconate (Aster-X, Sandika pharmaceuticals Pvt. ltd. New Delhi). Using 24-gauge needle, Inferior Alveolar Nerve Block with 2ml of local anaesthetic (Lox 2%, Neon Lab., New Delhi) will be administered to anesthetized the tooth. After placing the rubber dam, caries will be removed and any missing proximal wall will be restored with composite. Access to pulp chamber will be gained using a round diamond bur (# 1013, Microdont, Sao Paulo, Brazil) operated at high speed (KaVo Parte Genuina, Turbina Extra Torque 606, Santa Catrina, Brazil) under air water coolant. Coronal pulp tissue will be excised using a sharp spoon excavator till the level of the canal orifice. Pulp vitality will be confirmed by the presence of bleeding pulp tissue from all respective canals. In the root with normal architecture, haemostasis will be achieved by the application of a cotton pellet moistened with 2.5% NaOCl for 2 minutes on which dry cotton pellet will be further placed and this procedure will be repeated if required up to 10 minutes to control the bleeding. Bleeding time will be recorded. Once haemostasis is achieved, MTA of 2-3 mm thickness which will be mixed according to manufacturer’s instructions, is placed above the orifices using an amalgam carrier and gently packed using a condenser. A layer of light cure GIC (Densply DeTrey GmbH, Konstanz, Germany) will be placed over MTA and light cured for 20s. The working length will be determined in root with periapical lesion with electronic apex locater operated as per manufacturer’s recommendations and reconfirmed by a digital intraoral periapical radiograph.  
Intervention  pulpotomy   Full pulpotomy: The patient will be requested to rinse the oral cavity with 10 ml. of 0.2% chlorhexidine digluconate (Aster-X, Sandika pharmaceuticals Pvt. ltd. New Delhi). Inferior alveolar nerve block (IANB) (Lox 2%, Neon Lab., New Delhi) will be administered to anesthetize the tooth. After 15 minutes to IANB, the tooth was subjected to EPT. A negative response ensures the successful nerve block. Supplemental technique (Intra-osseous injection/Intra-ligamentary injection) was used to achieve the anesthesia of pulp in case of failure of primary IANB. Once the anaesthesia was achieved, the tooth will be isolated with a rubber dam. The crown will be disinfected with 5.25% NaOCl (Dentro, Mohali, India) before caries excavation. The carious tooth structure was removed, and any missing proximal wall was restored with composite. The access to pulp chamber was gained using a sterile round diamond bur (# 1013, Microdont, Sao Paulo,Brazil) operated at high speed (Kavopartegenuina, turbine extra torque 606, Santa Catrina, Brazil) under air-water coolant. Haemorrhage on entering the pulp chamber will be confirmed by clinical diagnosis of vital inflamed pulp. Absence of haemorrhage will considered as an indicator of necrotic pulp, and the tooth was excluded from the study. The inflamed coronal pulp tissue was excised with a high-speed round but under water coolant. A cotton pellet moistened with 2.5% NaOCl will be applied at the orifice for 2 minutes to control the bleeding and will repeated if required up to 10 min; time required to arrest the bleeding will be recorded. If the haemostasis will not achieved within 10 minutes, the tooth will be excluded from the study and standard root canal therapy will be carried out for the excluded teeth. Once the haemostasis will achieved, the chamber will be flushed with 5ml of 2.5% NaOCl solution. MTA powder was mixed with distilled water in a 3:1 ratio following manufacture instructions. A layer of 2-3mm MTA was placed over the pulp chamber floor using the MAP system. It was gently packed using a moist cotton pellet. A wet cotton pellet was applied over the layer of MTA for 10 minutes. Thereafter, 2-3 mm layer of RMGIC (Fuji II LC, GC Dental Int, Leuven, Belgium) was placed over MTA and light-cured for 20s. The remaining cavity was selectively etched with 37% phosphoric acid for 30 seconds and rinsed. The bonding agent (IvoclarTetric N Bond Universal Bonding Agent , Schaan, Liechtenstein) was applied to the cavity with micro-brush and agitated for at least 20 seconds. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  • Healthy patient of either gender between 18-45 years of age group.
• Mandibular molar teeth with definitive clinical diagnosis of irreversible pulpitis with periapical involvement (PAI score ≥ 3) in either of the roots.
• Positive response to either cold or EPT testing.
• The tooth is restorable.
• Probing pocket depth and mobility are within normal limits.
• Cone Beam Computed Tomography records of the patient. Periapical lesion with PAI score ≥ 1 on CBCT will be taken.
 
 
ExclusionCriteria 
Details  • Teeth with definitive clinical diagnosis of irreversible Pulpitis which are not associated with periapical rarefaction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
a)Full pulpotomy

b)Combination of non-surgical endodontic therapy and vital pulp therapy

Clinical evaluation as well as radiographic evaluation ( including Intra oral peri apical radiograph and Cone beam computed tomography) were done to evaluate for periapical healing


 		 Day zero:- Inta-oral periapical radiograph and Cone beam computed tomography

At six month follow-up:- Intra-oral periapical radiograph

At Twelve month follow-up :-
Intra-oral periapical radiograph and Cone beam computed tomography  
 
Secondary Outcome  
Outcome  TimePoints 
healing of periapical lesion  1 year 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   28/03/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The conventional treatment for management of teeth with symptomatic irreversible pulpitis is non-surgical endodontic therapy (NSET). This was based on the premise that entire pulp would degenerate in totality (Strangulation theory) (3). However, due to enhanced understanding of the pulp pathophysiology, the notion has changed and the current theory put forwards the concept that pulpal changes occur in stages with the degeneration occurring from coronal to radicular pulp denoting that vital pulp tissue is expected in the radicular part in teeth with irreversible pulpitis (3). Hence there has been a paradigm shift in the management of teeth with symptomatic irreversible pulpitis. Full pulpotomy is being advocated. Hemorrhage control is an important factor in determining whether the inflammation has progressed into radicular pulp. If pulpal bleeding continues for more than 10 minutes the treatment of choice is pulpectomy. Several agents are being used for hemorrhage control in pulpotomy. The most commonly used is 2.5% NaOCl.But it is toxic to the pulp &ineffective in deeper pulpal tissues (55). Cryotherapy has hemostatic, anti-inflammatory &analgesic properties. Cryotherapy is a non toxic and cost effective method for the patients. There is no study available in the literature that has investigated the effect of cryotherapy on the treatment outcome of full pulpotomy performed in mature permanent mandibular molar teeth with symptomatic irreversible pulpitis. This study is done to evaluate the effect of cryotherapy on the treatment outcome of full pulpotomy performed in mature permanent mandibular molar teeth with symptomatic irreversible pulpitis.In this study we are using an indigenous cryotherapy delivery unit which maintains the delivery of cold saline constantly at 2.50C for 10 minutes to improve the effect of the treatment.
 
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