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CTRI Number  CTRI/2012/11/003102 [Registered on: 12/11/2012] Trial Registered Retrospectively
Last Modified On: 12/11/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Root canal treatment without obturation with regenerative technique 
Scientific Title of Study   A randomized equivalence clinical trial to evaluate the efficacy of an innovative, non-obturation endodontic treatment protocol “SealBio” for mature, permanent non-vital teeth as compared to conventional endodontic treatment with root canal obturation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naseem Shah 
Designation  Professor 
Affiliation   
Address  Department of Conservative dentistry & Endodontics Centre for Dental Education & Research All India Institute of medical Sciences

South
DELHI
110029
India 
Phone  26589304  
Fax  26588663  
Email  naseemys@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naseem Shah 
Designation  Chief 
Affiliation  Centre for dental education and research 
Address  All India Institute of medical Sciences

South
DELHI
110029
India 
Phone  26589304  
Fax  26588663  
Email  naseemys@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naseem Shah 
Designation  Chief 
Affiliation  Centre for dental education and research 
Address  All India Institute of medical Sciences

South
DELHI
110029
India 
Phone  26589304  
Fax  26588663  
Email  naseemys@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  V. Ramalingaswami Bhawan, Ansari Nagar P.Box No. 4911 New Delhi – 110029  
Type of Sponsor  Government funding agency 
 
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 Naseem Shah  Department of Conservative Dentistry and Endodontics, 3rd Floor, CDER  All India Institute of Medical Sciences
South
DELHI 		 26589304

naseemys@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Periapical pathologies associated with infected, non-vital mature, permanent teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Endodontic technique  After control of intra canal infection by chemo-mechanical means,the root canals will be obturated with gutta percha and sealer cement 
Intervention  Innovative non-obturation Endodontic technique  After control of intra canal infection by chemo-mechanical means, indigenous stem cells residing in the periapical area of teeth being treated are stimulated by intentional over-instrumentation beyond the apical foramen. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Cases presenting with clinical or radiographic signs and symptoms of
periapical pathologies, irrespective of age and sex will be included in
the study 
 
ExclusionCriteria 
Details  Patients having any systemic disease, which can compromise the
healing response such as diabetes, patients on excessive
medications, on immuno-suppressants, those receiving RT or CT etc. will not be included 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete control and resolution of clinical signs
and symptoms of periapical disease, such as
pain, swelling, inflammation and restoration of
function
Radiographic evidence of healing of periapical
lesions showing disappearance or reduction in
size of the lesion or atleast arrest of lesion size
(not increasing) 		 followed up at 3, 6 months, 1, 1 ½ and 2 years  
 
Secondary Outcome  
Outcome  TimePoints 
Formation of a natural, biological seal of
mineralized tissue at the root apices 		 followed up at 3, 6 months, 1, 1 ½ and 2 years  
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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   N/A 
Date of First Enrollment (India)   01/10/2012 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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)?  

Brief Summary  

To evaluate and compare the healing response following novel, non-obturation endodontic treatment and the conventional endodontic treatment protocol by clinical and radiographic evaluation with pre and post treatment digital intra-oral X-ray and Cone Beam Computed Tomography (CBCT).

192 cases of at least 2 periapically infected teeth will be included in the study (Sample calculation shown in Materials and methods). Ethical clearance and informed consent of the patient will be taken.  Inclusion and exclusion criteria will be laid down and followed. One of the affected teeth will be treated by conventional endodontic procedure of cleaning, shaping, disinfection, obturation and coronal seal. The other tooth will be treated by the novel treatment protocol. Pretreatment digital intraoral periapical X rays and CBCT will be taken. The cases will be followed up at 3, 6 months, 1, 1 ½ and 2 years and evaluated clinically and radiographically. Post treatment CBCT will be taken only at 6-months interval. The data will be analyzed and healing response will be compared in the two groups.

 

 

 

 

 
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