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CTRI Number  CTRI/2024/06/069389 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 02/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical and Radiographic Success of Root Canal Treatment for Milk Teeth after Using Laser or Antibiotic Paste as Canal Disinfectant  
Scientific Title of Study   Clinico-Radiographic Evaluation and Anti-Microbial Efficacy of Chlorhexidine Solution (CHX), Modified Triple Antibiotic Paste (MTAP) and Diode Laser as Disinfectant in Mandibular Primary Molar Pulpectomy -A Randomized 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  Sakshi Mishra  
Designation  Post Graduate student 
Affiliation  Sumandeep Vidyapeeth Deemed To Be University, Pipaliya, Vadodara 
Address  Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  07558464477  
Fax    
Email  ssaakshimishra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anshula Deshpande 
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth Deemed To Be University, Pipaliya, Vadodara 
Address  Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7600916400  
Fax    
Email  dranshula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anshula Deshpande 
Designation  Professor 
Affiliation  Sumandeep Vidyapeeth Deemed To Be University, Pipaliya, Vadodara 
Address  Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7600916400  
Fax    
Email  dranshula@gmail.com  
 
Source of Monetary or Material Support  
K M Shah Dental College and Hospital ,Sumandeep Vidyapeeth Deemed To Be University, Pipaliya, Vadodara 
 
Primary Sponsor  
Name  Sakshi Sharadkumar Mishra  
Address  K M Shah Dental College and Hospital ,Sumandeep Vidyapeeth Deemed To Be University, Pipaliya, Vadodara 
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 Sakshi Mishra  K M Shah Dental College and Hospital  Room number 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Vadodara
Vadodara
GUJARAT 
7558464477

ssaakshimishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee (SV IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases, (2) ICD-10 Condition: K047||Periapical abscess without sinus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine solution  2% Chlorhexidine solution as intracanal disinfectant will be placed in canal for 7 days and tooth will be sealed with temporary restoration 
Intervention  Diode Laser and Modified Triple Antibiotic Paste  Low wavelength diode laser (Biolase Laser) will be used in canal for 1 minute and tooth will be sealed for 7 days with temporary restoration Modified triple antibiotic paste Metronidazole, Ciprofloxacin and Clindamycin paste will be made and inserted in canal for 7 days and tooth will be sealed with temporary restoration 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Patients between 4 to 10 years having deciduous teeth with infected pulp.
2. Teeth with more than two-third of root length intact
3. Children having mandibular primary molars diagnosed with pulp necrosis, chronic irreversible pulpitis, physiologic root resorption equal to or less than one-third
4. Normal and healthy patients with no systemic disease.
5. Guardian who are willing to give a written informed consent and assent by children will be included in the study. 
 
ExclusionCriteria 
Details  1. Childrens those who have been administered antibiotics in the last three months before the date of reporting.
2. Teeth with pulp canal obliteration or internal or external pathological root resorption visible in periapical radiographs.
3. Teeth which are previously treated with pulpectomy procedures
4. Patients with cellulitis / space infection
5. Patients allergic to antibiotics used (Metronidazole, Ciprofloxacin, Clindamycin)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The results of the present study will provide the dental professionals, the better evidence for the choice of canal disinfectant. The results and their interpretation could be a valuable addition to the one already available in literature and help the clinicians gain a better root canal disinfection using CHX , MTAP and Laser.  The outcome will be assessed at baseline, 6 months and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
The results of the present study will provide idea about duration to heal the lesion using different intracanal disinfection technique  The outcome will be assessed at baseline, 6 months & 12 months  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) 03/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/04/2026 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Various researches are being conducted in a pursuit of a method which may increase the success rate of root canal therapy in non-vital primary teeth with no damage caused to permanent teeth. Elimination of these resistant types of bacteria from root canals is considered as a serious challenge in root canal therapy. Recently, lasers with different wavelengths have proved to be able to clear the canals in permanent and primary teeth. These lasers disinfect the canals from resistant bacteria such as E. faecalis.  High-power lasers are among the newly introduced techniques for root canal disinfection. Evidence shows that diode lasers (DLs) can decrease the intracanal bacterial count and penetrate 500 µm into the surface. Bacterial elimination by incorporating use of laser for pulpectomy in the canals of primary teeth can provide infection free periodontal structure and fast healing in abscessed teeth. DL has the advantage of penetrating into the anatomic irregularities of the root canal structure and application of a DL in conjunction with irrigants has shown more favorable results. The bacterial reduction depends on radiation energy, bacterial species, time of radiation, and radiation frequency.  Different studies have used laser for root canal disinfection with range of 810, 880, 940, 980 nm wavelength. The study conducted by AA, Mohammed, El-Bayoumy YS, Barakat FI, and Edrees FM. on primary molars with 980nm diode laser concluded that laser was found to be more effective than 2% CHX, another study showed that  810-nm DL obstructed the dentinal tubules and decreased the Escherichia coli and E. faecalis bacterial counts. Therefore, this study will focus on clinical, radiographical and microbiological efficacy of canal disinfectants which includes 2% CHX, MTAP and diode laser when used in pulpectomy procedure.

 

NEED OF THE STUDY:

Search for new methods to increase the success rate of root canal therapy in children to prevent damage to permanent teeth is still going on. Elimination of these resistant types of bacteria from root canals is considered as a serious challenge in root canal therapy. Lasers with various wavelengths have recently been shown to be capable of clearing the canals in both permanent and primary teeth. Various root canal disinfectants are used routinely in pediatric dentistry for pulpectomy procedures. CHX demonstrates a broad-spectrum antimicrobial action and thus helps in reducing bacterial load in canals.  MTAP helps in elimination of both aerobic and anaerobic bacteria. Lasers reduces inflammation, relieves pain and also accelerates tissue generation. Taking these advantages into consideration the present study will evaluate CHX, MTAP and Diode laser for disinfection of canals in primary teeth and clinical success with long term follow-up.

On searching the literature till 18 March 2024 with the keywords like Diode laser , pulpectomy, necrosed pulp, root canal disinfectant on search engines like Pubmed, Medline, Researchgate, Google Scholar gave scanty results and in their limitation of study it was suggested study to be done with larger sample size and long term follow up , thus the need of the study to assess efficacy of diode laser as root canal disinfectant in primary teeth as compared to CHX  and MTAP.

NULL HYPOTHESIS:

There is no difference between CHX, MTAP and diode laser as root canal disinfectants in pulpectomy procedures of primary teeth when compared clinically, radiographical and microbiologically 

RESULT:

The present randomized clinical trial evaluated the antimicrobial, clinical, and radiographic efficacy of Chlorhexidine (CHX), MTAP, and diode laser as root canal disinfectants in primary teeth undergoing pulpectomy. All three groups showed significant reduction in E. faecalis and S. mutans counts postoperatively (p<0.001). The diode laser demonstrated the greatest reduction in E. faecalis and showed significantly better antimicrobial efficacy than CHX. Clinically, all groups exhibited marked improvement in pain, tenderness, swelling, mobility, and abscess, with almost complete resolution by 6 and 12 months. Radiographically, progressive healing with reduction in periradicular and intraradicular radiolucencies was observed in all groups, with the laser group showing comparatively faster healing. No adverse effect on tooth bud development was noted. Nolla stage assessment demonstrated continuous and significant tooth development over the follow-up period in all groups. Overall, all three disinfectants were effective, while diode laser showed comparatively superior antimicrobial and early radiographic outcomes.

CONCLUSION:

Within the limitations of the present study, all three root canal disinfectants—Chlorhexidine, MTAP, and diode laser—were effective in reducing microbial load and achieving favorable clinical and radiographic outcomes in primary teeth undergoing pulpectomy. Significant reduction in E. faecalis and S. mutans counts, along with progressive healing and resolution of clinical symptoms, was observed in all groups over 12 months. However, the diode laser demonstrated comparatively superior antimicrobial efficacy and earlier radiographic healing, particularly against E. faecalis. None of the treatment modalities adversely affected the development of the permanent tooth bud. Thus, diode laser may be considered a promising adjunctive disinfectant in pediatric pulpectomy procedures.


 
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