| CTRI Number |
CTRI/2024/03/064767 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessing the effect of hard and soft tissue laser application in reestablishing lost vitality inside a tooth. |
|
Scientific Title of Study
|
Efficacy of Erbium: Yttrium Aluminium Garnet and Diode laser in enhancing the tissue regeneration ability and clinical outcome in regenerative endodontics |
| 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 Biji Brigit |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9740949362 |
| Fax |
|
| Email |
drbijibrigit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KIran Kumar N |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9449588573 |
| Fax |
|
| Email |
kiransenate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biji Brigit |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Fort, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9740949362 |
| Fax |
|
| Email |
drbijibrigit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Biji Brigit |
| Address |
Associate Professor, Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Fort, Bangalore |
| 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 Biji Brigit |
Government Dental College and Research institute |
Department of Conservative Dentistry and Endodontics, Government Dental College and Research Institute, Fort, Bangalore
Bangalore
KARNATAKA |
9740949362
drbijibrigit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Dental College and Research Institute, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M279||Disease of jaws, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Revascularisation with Diode laser application |
in the first appointment during cleaning and shaping sodium hypochlorite will be activated with infrared diode Laser power set at
2.5W for 15 seconds x 2 cycles. Then the canal will be closed with out triple antibiotic paste. After 2 weeks canal will be reopened and bleeding will be induced and canal will be closed in the same manner as in the comparator
Duration: Diode laser irradiation will be done to activate sodium hypochlorite in the first appointment for a total duration of 30 seconds. After 2 weeks, in the second appointment if patient is asymptomatic, revascularization procedure will be carried out.
If, in the second appointment, symptoms persist the same irradiation protocol will be repeated for 30 seconds. After another 2 weeks, if symptoms persist the patient will be given triple antibiotic paste and excluded from the study. The intervention will not be repeated during follow up. |
| Comparator Agent |
Revascularization procedure with triple antibiotic paste |
In necrotic teeth with chronic apical periodontitis revascularization procedure as per the American Association of endodontista will be carried out. in the first appointment access opening, cleaning will be done with sodium hypochlorite as irrigant. Canal will be closed with triple antibiotic paste. After 2 weeks, bleeding will be induced and platelet rich fibrin scaffold will be placed. biodentin will be placed as coronal barrier and glass ionomer cement will be placed. |
| Intervention |
Revascularization with Er:YAG laser irradiation |
In the first appointment Er:YAG laser will be used to activate sodium hypochlorite at a frequency of 10 Hz for 60 seconds x 1 cycle instead of diode laser. Rest of the procedure will be same as the diode laser group.
Duration: Er:YAG laser irradiation will be done to activate sodium hypochlorite in the first appointment for a total duration of 60 seconds. After 2 weeks, in the second appointment if patient is asymptomatic, revascularization procedure will be carried out.
If, in the second appointment symptoms persist the same irradiation protocol will be repeated for 60 seconds. After another 2 weeks, if symptoms persist the patient will be given triple antibiotic paste and excluded from the study. The intervention will not be repeated during follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult male or female subjects 18–50 years of age
with Single rooted mature teeth with single canals
with Negative response to pulp sensibility test and Peri apical index (PAI) score-3 or 4 |
|
| ExclusionCriteria |
| Details |
Teeth with periodontal disease, cracks, and minimal coronal structure, Subjects with systemic disease, Pregnant and lactating females |
|
|
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 |
| Resolution of symptoms |
Assessment of symptoms at 1 month, 3 months, 6 months, 12 months and 24 month intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The resolution of periapical lesion size & positive response to pulp sensibility tests. |
Pulp sensibility tests & digital radiographs at 1 month, 3 months, 6 months, 12 months & 24 month intervals. CBCT at 12 month recall visit. |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="3"
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
|
The study is designed to assess the success of revascularization in mature teeth with periradicular lesion and the effect of laser in enhancing the regenerative ability.The experimental groups are Group 1: Regenerative endodontic procedure (REP) procedure similar to American Association of Endodontists clinical considerations (2016) for immature teeth Group 2: Diode Laser Group 3: Er: YAG laser A power analysis was established by G*power, version 3.0.1(Franz Faul universitat, Kiel, Germany). A sample size of 51 (17 per group) would yield 90% power to detect significant differences, with assuming the effect size of 0.2, (Eldessoky et al) and significance level at 0.05. Considering 20% attrition rate, total sample size is 51+12= 63 (21 per group) Group 1 the standard revascularization procedure will be carried out as per the AAE guidelines which includes triple antibiotic paste in first appointment for disinfection followed by revaculrization and pRF placement in second appointment which is after 14 days. in group 2 and group 3 laser assisted irrigation will be used for disinfection and triple antibiotic paste will not be used. during the revascualrization visit photobiomodulation with the respective laser will be done. patients will be recalled at 1month, 3 months, 6 months, 12 months and 24 months for clinical assessment of symptoms, pulp sensibility tests, digital radiographic assessmnt. CBCT will be done at 12 month follow up to evaluate the regression of periapical lesion. |