| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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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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