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CTRI Number  CTRI/2024/07/070900 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of photodynamic therapy in diabetic patients with apical periodontitis. 
Scientific Title of Study   Role Of Antimicrobial Photodynamic Therapy During Non Surgical Root Canal Treatment Of Teeth Having Apical Periodontitis In Individuals With Type 2 Diabetes Mellitus – A Clinical And Radiographic Evaluation. 
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 Abinia vaishnavi N 
Designation  Junior Resident ( Conservative dentistry and Endodontics) 
Affiliation  Faculty of Dental Sciences, King Georges Medical university, Lucknow 
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences , King Georges Medical University, Lucknow, UTTAR PRADESH

Lucknow
UTTAR PRADESH
226003
India 
Phone  9043377870  
Fax    
Email  avnsasi7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Bharti 
Designation  Professor ( Conservative dentistry and Endodontics) 
Affiliation  Faculty of Dental Sciences King Georges Medical university Lucknow 
Address  Department of Conservative Dentistry and Endodontics Faculty of Dental Sciences King Georges Medical University Lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9935724723  
Fax    
Email  rameshbharti@kgmcindia.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pragya pandey 
Designation  Professor (Junior grade) 
Affiliation  Faculty of Dental Sciences King Georges Medical University Lucknow  
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences , King Georges Medical University, Lucknow Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  8415942428  
Fax    
Email  w.pragya78@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Faculty of Dental Sciences, King George’s Medical University, Lucknow 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 Abinia Vaishnavi N  Faculty of Dental Sciences King Georges Medical University, Lucknow  First floor , Old dental building Department of Conservative dentistry and Endodontics . Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH 		 9043377870

avnsasi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Photodynamic therapy  Root canal treatment using photodynamic therapy with nontoxic photosensitizer dye as disinfection method which will be used 3 times for 30 sec duration. 
Comparator Agent  Sodium Hypochlorite  Root canal treatment using 5.2% Sodium hypochlorite as disinfection method , 3 ml of sodium hypochlorite will be used 3 times for 30 secs. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients with a history of type 2 DM (with HbA1c ≥6.5%)
2. Mature permanent teeth with apical periodontitis as confirmed by a negative response to cold and electric pulp tests
3. Radiographic evidence of AP (minimum size 2 mm ×2 mm)
 
 
ExclusionCriteria 
Details  1. Patients with Periodontitis with pocket depth ≥ 4mm
2. Systemic disorders other than diabetes mellitus (type 2)
3. Patients taking steroids, pregnant patients
4. Patients with cracks/fractures of the tooth
5. Patients who underwent a procedural errors
6. Smokers
7. Patients with a history of antibiotic intake in the preceding month were excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
change in apical bone density (PAI score) at 3, 6 months time interval and the presence of clinical signs & symptoms or abnormal findings (ie, spontaneous pain, presence of sinus tract, swelling, mobility, periodontal probing depth greater than baseline measurements, or sensitivity to percussion and palpation).   Baseline, 3 & 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the periapical healing with glycemic level of the patient   Baseline, 6 months  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   22/08/2024 
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="0"
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 - NO
Brief Summary  
INTRODUCTION:
        The success of endodontic treatment depends on the eradication of microbes from the root canal system. It is well established that the complete elimination of bacteria from root canals is extremely difficult, because of the intricate canal anatomy (1). Even thorough preparation of the root canal leaves part of the canal walls untouched, regardless of the instrumentation technique used (2), resulting in inconsistent removal of the contaminated
innermost layer of dentin (3,4). Accepted treatment procedures for root canal disinfection include mechanical debridement and shaping, irrigation with disinfecting agents such as sodium hypochlorite (NaOCl) and chlorhexidine, application of an interappointment antibacterial dressing, and sealing of the root canal (5,6). Novel approaches for disinfecting root canals include the use of high-power lasers (7) as well as photodynamic therapy (PDT) (8,9). High-power lasers function by dose-dependent heat generation. However, they have the potential to cause damage such as dentin charring, ankylosis, cementum melting, root resorption, and periradicular necrosis if
incorrect laser parameters are used (10). PDT is a new antimicrobial strategy that involves the use of a nontoxic photosensitizer (PS) and a light source (11). The evidence available from the existing literature regarding the relationship among Diabetes Mellitus, Apical periodontitis, and endodontic outcome is unclear.
On searching the literature, we found a few studies discussing the relationship between diabetes and Apical periodontits (13–17). Most of the studies are cross-sectional studies with a low level of evidence and have mainly investigated the prevalence of Apical Periodontitis in diabetic patients and not the endodontic success. Suman Arya et al. (2017) concluded that diabetes mellitus may have a negative impact on the outcome of endodontic
treatment in terms of periapical healing (20). Thus, the present study was designed in a prospective manner, with the objective to investigate the success rate of primary nonsurgical root canal treatment with adjuvant
photodynamic therapy in type 2 diabetic patients and possible association of periapical healing with HbA1c level.

AIMS AND OBJECTIVES
 1. Clinical and radiographic evaluation of primary nonsurgical root canal treatment with
photodynamic therapy in type 2 diabetic patients with] apical periodontitis.
2. To investigate the possible association of periapical healing with HbA1c levels. 

MATERIALS AND METHODS:
         The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow.
        The study will be conducted only after getting clearance from Institutional Ethical Committee and registration in CTRI. 
       Study Population: Patients diagnosed with type 2 diabetes mellitus and apical periodontitis who provide written consent will be eligible for the study.

       Randomization: Eligible patients will be randomly assigned to one of two test groups.

Treatment Groups:
Group I: Patients in this group will undergo biomechanical preparation followed by obturation.
Group II: Patients in this group will undergo biomechanical preparation followed by photodynamic therapy and then obturation.
Biomechanical Preparation: Both groups will receive biomechanical preparation, which involves cleaning and shaping the root canal system to remove infected or necrotic tissue.

Photodynamic Therapy (Group II): Patients in Group II will receive photodynamic therapy after biomechanical preparation but before obturation. This involves the use of light-sensitive compounds and light to target and destroy bacteria in the root canal system.

Obturation: After either biomechanical preparation (Group I) or photodynamic therapy (Group II), the root canal will be filled and sealed with a suitable material (obturation).

Evaluation:
Clinical Evaluation: Both groups will undergo clinical evaluation at specified time intervals to assess symptoms, such as pain or swelling, and overall oral health.
Radiographic Evaluation: X-rays will be taken at appropriate intervals to assess the healing of the apical periodontitis and the quality of the obturation.
Statistical Analysis: The data collected from clinical and radiographic evaluations will be subjected to statistical analysis to compare the outcomes between the two groups.

Adaptations: If any changes are deemed necessary during the study, they will be made in the best interest of the study’s integrity, possibly based on interim analyses or emerging literature.

This protocol outlines a rigorous scientific approach to evaluating the effectiveness of photodynamic therapy in conjunction with traditional root canal treatment in patients with type 2 diabetes mellitus and apical periodontitis.

INCLUSION CRITERIA
1. Patients with a history of type 2 DM (with HbA1c ≥6.5%)
2. Patients age within 30-55 years
3. Mature permanent teeth with apical periodontitis as confirmed by a negative
response to cold and electric pulp tests
4. Radiographic evidence of AP (minimum size 2 mm ×2 mm)

EXCLUSION CRITERIA
1. Patients with Periodontitis with pocket depth ≥ 4mm
2. Systemic disorders other than diabetes mellitus (type 2)
3. Patients taking steroids, pregnant patients
4. Patients with cracks/fractures of the tooth
5. Patients who underwent a procedural errors
6. Smokers
7. Patients with a history of antibiotic intake in the preceding month were excluded from the study.
 
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