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CTRI Number  CTRI/2024/05/068117 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Antimicrobial efficacy of three different intracanal Endodontic medications. 
Scientific Title of Study   Comparative Evaluation of three differ-ent intracanal medicaments for antimi-crobial efficacy in single rooted teeth with Pulp Necrosis and Asymptomatic Apical periodontitis–A Randomized double-blinded Clinical Study 
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. Bhandary Vidula Vijay 
Designation  POSTGRADUATE 
Affiliation  K M Shah Dental College And Hospital 
Address  Department of Conservative and Endodontics K M Shah Dental College And Hospital Sumandeep Vidyapeeth Campus Waghodia Road Piparia Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9664114952  
Fax    
Email  vidulabhandary97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dexter Brave 
Designation  Reader 
Affiliation  K M Shah Dental College And Hospital 
Address  Department of Conservative and Endodontics Room number 8 K M Shah Dental College Sumandeep Vidyapeeth Waghodia road Piparia Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9833048365  
Fax    
Email  sanctus002@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dexter Brave 
Designation  Reader 
Affiliation  K M Shah Dental College And Hospital 
Address  Department of Conservative and Endodontics Room number 8 K M Shah Dental College Sumandeep Vidyapeeth Waghodia road Piparia Vadodara Gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9833048365  
Fax    
Email  sanctus002@gmail.com  
 
Source of Monetary or Material Support  
Self Funded Department of Conservative and Endodontics Room number 8 K M Shah Dental College Sumandeep Vidyapeeth Waghodia road Piparia Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Dr Bhandary Vidula Vijay 
Address  K M Shah Dental College And Hospital Sumandeep Vidyapeeth Waghodia Road Piparia Waghodia Vadodara Gujarat 391760 
Type of Sponsor  Other [Self] 
 
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 Bhandary Vidula Vijay  K M Shah Dental College And Hospital  Department of Conservative and Endodontics Room no. 8 Sumandeep Vidyapeeth Waghodia road Piparia Vadodara Gujarat 391760
Vadodara
GUJARAT 		 9664114952

vidulabhandary97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  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 
Intervention  Angelus Bio-C Temp  Angelus Bio-C Temp is a ready-to-use bioceramic tricalcium silicate paste for intracanal dressing. Bio-C Temp (Angelus, Paraná, Brazil) is the first calcium-silicate based medicament for use between sessions. Bio-C Temp contains calcium silicates associated with calcium tungstate and titanium oxide radiopacifiers, besides calcium aluminate, calcium oxide and base resin. It is indicated for medication between sessions in necrotic teeth or retreatments, management of internal and/or external root resorption, and for the treatment of immature teeth. Bio-C Temp is a highly alkaline material that has microsized particles (2 μm), which improve flow, penetration into dentinal tubules, and material reactivity, favoring the release of Ca2+ and OH– ions, and bactericidal action due to high pH (12.5). Furthermore, alkaline phosphatase activity and deposition of mineralized nodules have been shown in human osteoblast-like cell line culture containing diluted extracts of Bio-C Temp, suggesting that this medication could present a bioactive potential. Bio-C Temp is an intracanal medication that eliminates the need for new applications, constituting an advantage over calcium hydroxide-based medications that require frequent changes. In this investigation, Angelus Bio-C temp is the intervention group intended to be evaluated by the reduction in colony forming units. 
Comparator Agent  Calcium Hydroxide  Calcium hydroxide (Ca(OH)â‚‚) is a widely used intracanal medicament in endodontics due to its excellent antimicrobial properties and ability to induce hard tissue formation. Heres an overview of its key aspects: Antimicrobial Properties Alkaline pH: Calcium hydroxide has a high pH (approximately 12.5), which creates an environment that is hostile to most bacteria, including common endodontic pathogens like Enterococcus faecalis. Bactericidal Effect: The high pH disrupts bacterial cell walls and denatures proteins, leading to bacterial death. Induction of Hard Tissue Formation Stimulates Healing: Calcium hydroxide promotes the formation of hard tissue barriers, making it useful for procedures like apexification and the treatment of perforations. Dentin Bridge Formation: It encourages the deposition of mineralized tissue in the pulp cavity, aiding in the formation of a dentin bridge. Usage in Root Canal Treatment Temporary Filling Material: It is often used as a temporary intracanal medicament between appointments to disinfect the canal and provide a protective barrier. Long-term Antimicrobial Effect: The slow release of hydroxyl ions ensures a sustained antimicrobial effect over time.In this investigation Calcium Hydroxide is the control group intended to be evaluted by reduction in colony forming units 
Comparator Agent  Double antibiotic paste   Double antibiotic paste(DAP) is an intracanal medicament that is a combination of metronidazole and ciprofloxacin. DAP is known to be impactful against various microorganisms in the endodontic and periapical regions. Although minocycline has been shown to be effective, tooth discoloration associated with it led to increased use of DAP which shows similar results.It serves as an intracanal medicament in cases of necrotic pulp tissue and periapical pathology, helping to reduce bacterial load and inflammation. In this group Double antibiotic paste is the comparator group intended to be evaluted by reduction in colony forming units. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients (Category: American Society of Anaesthesiologists
class 1) (ASA House of Delegates 2014)31 between age group of 18-60 years with
maxillary or mandibular single rooted necrotic teeth with radiographic and clinical
evidence of asymptomatic apical periodontitis will be included in the study.
2. Teeth with necrotic pulps confirmed clinically by pulp sensitivity tests will be included.
3. Patients having no previous history of endodontic treatment will be included.
4. Patients having periapical lesions with a periapical index score of 2 and above (Ørstavik et al. 1986) will be included
5. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study 
 
ExclusionCriteria 
Details  1. Medically compromised patients will be excluded.
2. Patients who have received NSAIDs or antibiotic treatment in the three months before
the study will be excluded.
3. Teeth with completely obliterated canals will be excluded.
4. Teeth with evidence of sinus tracts, pus discharge and weeping canals will be excluded.
5. Cases showing periodontal pocket depth deeper than 4mm will be excluded.
6. Teeth with open apex, root resorption or complex root canal anatomy will be excluded.
7. Teeth with developmental anomalies will be excluded.
8. Teeth with vertical root fractures, cracks will be excluded.
9. Pregnant and lactating women will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparative evaluation of reduction of colony forming units in the intervention, comparator and control groups.  Baseline(day of initiation of treatment)
7th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 4 
Date of First Enrollment (India)   10/06/2024 
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)
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   Dental caries, a progressive disease of the dental hard tissue, if left untreated in its initial stages, may lead to pulpal, periapical, and/or intraradicular infections. Reduction or elimination of the bacterial infection seems to be one of the important factors for the success of endodontic treatment of teeth with necrotic pulp . However, several studies have reported that chemomechanical instrumentation alone is unable to eliminate all root canal bacteria. The remaining viable bacteria left in the root canal may multiply between appointments or following obturation often reaching a pathogenic level and leading to failure. Hence, a suitable intracanal medicament is required to disinfect the root canal system prior to obturation so as to promote healing and prevent recurrence. Calcium hydroxide is the most commonly used intracanal medicament during root canal therapy. Studies using agar diffusion method have reported that Calcium Hydroxide associated with an inert substance (distilled water, saline solution or glycerine) was ineffective in inhibiting the growth of several obligate and facultative anerobic bacteria8. To overcome this drawback a combination of different antibiotics has been studied to increase the scope of antibacterial coverage. DAP is an intracanal medicament that is a combination of metronidazole and ciprofloxacin. But calcium hydroxide and double antibiotic paste (DAP) can have deleterious effects on root dentin. Angelus Bio-C Temp is a ready-to-use bioceramic tricalcium silicate paste for intracanal dressing. Bio-C Temp (Angelus, Paraná, Brazil) is the first calcium-silicate based medicament for use between sessions. Bio-C Temp contains calcium silicates associated with calcium tungstate and titanium oxide radiopacifiers, besides calcium aluminate, calcium oxide and base resin. Bio-C Temp is a highly alkaline material that has microsized particles (<2 μm), which improve flow, penetration into dentinal tubules, and material reactivity, favoring the release of Ca2+ and OH– ions, and bactericidal action due to high pH (12.5). Despite thorough search in various databases like PubMed, Medline and EBSCO host conducted till March 2024 suggested no availability of studies evaluating the effect of Angelus Bio-C Temp on antimicrobial efficacy in vivo; this clinical study is therefore designed to compare and evaluate the antimicrobial efficacy of the same with that of Calcium Hydroxide and Double antibiotic paste in patients with pulp necrosis and asymptomatic apical periodontitis. 
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