| CTRI Number |
CTRI/2025/11/097392 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study “Comparing regular root canal cleaning with laser cleaning to see which works better in killing germs and healing front teeth.” |
|
Scientific Title of Study
|
comparative evaluation of antimicrobial efficacy and periapical healing with conventional irrigation versus adjunctive laser disinfection during endodontic treatment of anterior teeth :A Randomized clinical trial |
| 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 Saranya k |
| Designation |
Junior resident |
| Affiliation |
Dr.Jayasree S, Govt dental college ,Kozhikode |
| Address |
Govt dental college Kozhikode,department of conservative dentisry and endodontics Room no 60, Fourth floor
Govt dental college Kozhikode, department of conservative dentisry and endodonticsRoom no 60, Fourth floor
Kozhikode
KERALA
673008
India |
| Phone |
07593948477 |
| Fax |
|
| Email |
saranyakumar3911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasree S |
| Designation |
Head of the Department |
| Affiliation |
Dr.Jayasree S |
| Address |
Govt dental college Kozhikode,Department of conservative dentisry and endodontics Room no 60, Fourth floor
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saranya k |
| Designation |
Junior resident |
| Affiliation |
Dr.Jayasree S, Govt dental college ,Kozhikode |
| Address |
Govt dental college Kozhikode,department of conservative dentisry and endodontics Room no 60, Fourth floor
Govt dental college Kozhikode, department of conservative dentisry and endodonticsRoom no 60, Fourth floor
Kozhikode
KERALA
673008
India |
| Phone |
07593948477 |
| Fax |
|
| Email |
saranyakumar3911@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Saranya k |
| Address |
Govt dental college Kozhikode, dept of conservative dentistry and endodontics Room no 60, Fourth floor , Kerala , pin 673008 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr jayasree S |
Dr Saranya k |
Department of conservative dentistry and endodontics ,Room NO 60
Kozhikode
KERALA |
7593948477
saranyakumar3911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE, KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patient with chronic apical periodontitis on upper anterior teeth |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adjunctive laser disinfection |
Following parameters are assessed.1, antimicrobial efficacy by colony forming unit count 2,perapical healing by radigraphic assessment at 3,6 and 12 months |
| Comparator Agent |
Conventional irrigation technique
|
Following parameters are assessed.1, antimicrobial efficacy by colony forming unit count 2,perapical healing by radigraphic assessment at 3,6 and 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient requiring root canal treatment of anterior teeth having chronic apical periodontitis with score 4 periapical index ( PAI)
2. Healthy male and female patients, aged between 18 to 55 years
3. Teeth with a single root canal and no history of prior endodontic treatment. |
|
| ExclusionCriteria |
| Details |
1.Systemic disorders that could weaken the immune system.
2. The use of anti-inflammatory drugs or antibiotics within the past 3 months.
3. The requirement for antibiotic prophylaxis prior to dental treatment.
4. Calcified canals.
5. Developmental anomalies. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. antimicrobial efficacy
2. Periapical healing |
1. antimicrobial efficacy evaluated immediately after treatment
2. Periapical healing evaluated by radiographic assessment at 3,6and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
comparative evaluation of antimicrobial efficacy and periapical healing with conventional irrigation versus adjunctive laser disinfection during endodontic treatment of anterior teeth :A Randomized clinical trial
This study evaluates the antimicrobial efficacy and periapical healing with conventional irrigation versus adjunctive laser disinfection during endodontic treatment of anterior teeth .The total sample size of the study is 40and the study period is 18 months.
Null hypothesis states that There is no significant difference in the CFU reduction and periapical healing between conventional irrigation and adjunctive laser disinfection.
Outcome are assessed as follows, 1)antimicrobial efficacy determined by colony forming unit count in root canal using microbiological analysis. 2)periapical healing evaluated by radiographic assessment at 3,6 and 12 months. |