| CTRI Number |
CTRI/2025/06/089895 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Evaluating Diode vs. Er:YAG Lasers for Regenerative Endodontics and periapical healing in Young permanent Teeth"
|
|
Scientific Title of Study
|
The comparative evaluation of low level laser therapy using Diode and Er:YAG laser on regenerative endodontic treatment of Immature permanent teeth: An In-vivo 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 |
Rakesh kumar maretha |
| Designation |
Academic juniors resident |
| Affiliation |
Faculty of dental Sciences, IMSBHU, |
| Address |
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8769892788 |
| Fax |
|
| Email |
rakeshmaretha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh kumar maretha |
| Designation |
Academic juniors resident |
| Affiliation |
Faculty of dental Sciences, IMSBHU, |
| Address |
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
UTTAR PRADESH
221005
India |
| Phone |
8769892788 |
| Fax |
|
| Email |
rakeshmaretha1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh kumar maretha |
| Designation |
Academic juniors resident |
| Affiliation |
Faculty of dental Sciences, IMSBHU, |
| Address |
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
consrvative dentistry and endodontics,faculty of dental sciences,trauma center BHU Varanasi UTTAR PRADESH INDIA
UTTAR PRADESH
221005
India |
| Phone |
8769892788 |
| Fax |
|
| Email |
rakeshmaretha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental sciences ,IMS ,BHU |
|
|
Primary Sponsor
|
| Name |
Rakesh kumar maretha |
| Address |
conservative Dentistry and endodontics,fauclty of dental sciences,IMS,BHU |
| Type of Sponsor |
Other [] |
|
|
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 NeelamMittal |
Banaras Hindu University. |
room no.6 ,3rd floor,conservative dentistry andendodonticsdepartment,faculty ofdental sciences,traumacentre,VARANASI 221005
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9415203360
dr.neelammittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| banaras hinduuniversity,institute ofmedicalsciences,varanasi,India-221005 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
: Er:YAG low-level laser therapy, Diode low-level laser therapy combined with RET.
|
o Local anesthesia and rubber dam isolation will be administered.
o The necrotic pulp tissue will be removed, and the root canals will be irrigated with 1.5% sodium hypochlorite followed by saline.
o Canals will be dried with paper points and Calcium hydroxide dressing will be employed
o A sterile cotton pellet and temporary restoration will be placed, and the patient will be recalled after 2–4 weeks.
Second Visit: Regenerative Therapy
1.Initial Step:
o Local anesthesia and rubber dam isolation will be administered.
The root canals will be irrigated with 1.5% sodium hypochlorite followed by saline.
o Canals will be dried with paper points
2.Laser Application:
o Group C (Er:YAG Laser): The Er:YAG laser (wavelength: 2940 nm) will be used in non-contact mode to irradiate the oral mucosa near root apex at low energy settings (20–50 mJ/pulse, 10 Hz).
o Group D (Diode Laser): The diode laser (wavelength: 810–980 nm) will be applied in continuous-wave mode with low power (0.5–1.0 W) for photobiomodulation of the oral mucosa.
3.Inductive Material Placement:
o Bioactive materials, such as platelet-rich fibrin (PRF) will be introduced into the canal to promote regeneration.
o Evidence of bleeding from the apical tissues will be assessed to confirm regenerative potential.
o A bioceramic material will be used to seal the canal, followed by permanent restoration.
|
| Comparator Agent |
Blood Clot,PRF used as Scaffold in RET.
|
o Bioactive materials, such as platelet-rich fibrin (PRF) will be introduced into the canal to promote regeneration. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Necrotic immature permanent anterior teeth.
Open apex associated with or without periapical radiolucency less than 1.5 cm.
|
|
| ExclusionCriteria |
| Details |
1. Patients with medical conditions like cardiac problems, pregnant patients, diabetic patients, bleeding tendencies, HIV+ patients, hepatitis-B. All patients will go through HIV screening
2. Tooth that requires post and core, severely curved canals.
3. Tooth with calcified canals
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periapical healing and bone formation.
•Root length, apical closure and Dentinal axial wall thickness
|
6 months,1 year.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REGAINING OF SENSIBILITY TO THERMAL AND ELECTRIC PULPTESTS. |
6 months,12 months. |
|
|
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)
|
30/06/2025 |
| 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="1"
Months="6"
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
|
The study will focus on immature permanent teeth, typically those that have incomplete root development, often found in children or young adults. Generally apexification is considered as treatment option which can lead to tooth discoloration, tooth fracture and loss of protective mechanism of proprioception. Recently, Regeneration endodontic procedures have been successfully used to treat immature mature teeth with necrotic pulp. The regenerative process involves revitalizing the pulp tissue, promoting root development, and stimulating the natural healing mechanisms of the tooth. This study aims to assess how each type of laser (Diode vs. Er:YAG) influences the regenerative outcomes, such as: - Root lengthening and thickening
- Pulp vitality
- Healing of periapical tissues
Low-Level Laser Therapy (LLLT): The study will evaluate the effects of two types of lasers used in regenerative endodontic treatment. - Diode Laser: Known for its anti-inflammatory, antimicrobial, and tissue healing properties, this laser is commonly used in dental treatments.
- Er:YAG Laser: The Erbium-doped Yttrium Aluminum Garnet laser is used for its precision in soft and hard tissue procedures, particularly its ability to promote tissue regeneration and healing.
It evaluates the effectiveness of each laser in promoting tissue regeneration, root growth, and pulp vitality. By conducting an in-vivo analysis, the study will assess healing times, the quality of regenerated tissue, and potential clinical outcomes. The study seeks to determine which laser is more effective in enhancing the success and long-term health of immature teeth undergoing regenerative treatment |