| CTRI Number |
CTRI/2025/04/085345 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinico-radiographic evaluation of pulpotomy assisted by laser in mature permanent teeth with irreversible pulpitis |
|
Scientific Title of Study
|
Clinico-radiographic evaluation of laser assisted pulpotomy in mature permanent teeth with irreversible pulpitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshil Patel |
| Designation |
Post graduation student |
| Affiliation |
Government dental college and hospital, Ahmedabad. |
| Address |
Department of conservative dentistry and endodontics, Government dental college and hospital, Civil hospital campus, Asarwa, Ahmedabad, Gujarat 380016
Gandhinagar
GUJARAT
380016
India |
| Phone |
9426474279 |
| Fax |
|
| Email |
hjp.harshil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nupur Dhanak |
| Designation |
Assistant Professor |
| Affiliation |
Government dental college and hospital, Ahmedabad. |
| Address |
Department of Conservative dentistry and endodontics, Government dental college and hospital, Civil hospital campus, Asarwa, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428198077 |
| Fax |
|
| Email |
bhavsarnupur@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshil Patel |
| Designation |
Post graduation student |
| Affiliation |
Government dental college and hospital, Ahmedabad. |
| Address |
Department of conservative dentistry and endodontics, Government dental college and hospital, Civil hospital campus, Asarwa, Ahmedabad, Gujarat 380016
Gandhinagar
GUJARAT
382421
India |
| Phone |
9426474279 |
| Fax |
|
| Email |
hjp.harshil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college, Civil hospital campus, Asarwa, Ahmedabad-380016 |
|
|
Primary Sponsor
|
| Name |
Government dental college and hospital, Ahmedabad |
| Address |
Government dental college, Civil hospital campus, Asarwa, Ahmedabad-380016 |
| Type of Sponsor |
Other [Government Dental College and Hospital, Ahmedabad] |
|
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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 Harshil Patel |
Government dental college and hospital, ahmedabad |
Room No. A, No. 9, PG section of Department of Conservative dentistry and Endodontics, GDCH, Civil hospital campus, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT |
9426474279
hjp.harshil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Govt. Dental College & Hospital (IEC GDCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Haemostasis using 5.25% NaOCl (without laser)
2.Haemostasis using 940 nm diode laser at 1W of power in contact mode
|
After giving anaesthesia using 2% lignocaine with 1:80,000 epinephrine and rubber dam isolation, caries will be excavated using a sterilized big round diamond bur and pulp chamber will be accessed. Hemostasis will be achieved using sodium hypochlorite or 940 nm diode laser followed by MTA , GIC and final restoration in both the groups with or without apical periodontitis |
| Intervention |
Laser assisted Pulpotomy |
Laser assisted Pulpotomy will be done using MTA followed by GIC and composite restoration. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mature permanent teeth with carious pulp exposures and signs suggestive of irreversible pulpitis.
With/without clinical/radiographic signs indicative of apical periodontitis
Vital pulp (to be determined with pulp sensibility test - Cold test and EPT)
Restorable tooth and tooth without mobility and probing depth within normal limits.
Soft tissues around the tooth are normal with no swelling or sinus tract.
20-60 years of age range
Patients accepting to provide informed consent/available for the recall
|
|
| ExclusionCriteria |
| Details |
Non-vital and non-restorable teeth
Pathologic mobility or poor oral hygiene
Pregnant/lactating women
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laser-assisted pulpotomy can serve as an equivalent or superior method to conventional root canal treatment in mature permanent teeth exhibiting signs and symptoms indicative of irreversible pulpitis |
observation periods of 1 week, 1 month, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no pathosis on radiograph |
observation periods of 1 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
02/05/2025 |
| 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="0"
Months="6"
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
|
Clinico-radiographic evaluation of laser assisted pulpotomy in mature permanent teeth with irreversible pulpitisAIM - The aim of this prospective study is to investigate the influence of laser assisted pulpotomy on outcome of mature permanent teeth with symptomatic irreversible pulpitis. OBJECTIVE - To evaluate the clinical and radiographic success of laser-assisted pulpotomy in mature permanent teeth exhibiting clinical signs of irreversible pulpitis, with or without apical periodontitis, and with or without the application of a 940 nm diode laser, over observation periods of 1 week, 1 month, and 6 months EVALUATION CRITERIA •Clinical success - Assessment of postoperative pain using Numerical rating scale (NRS) •Radiographic success - Assessment of postoperative radiograph at 6 months for evaluation of any pathosis
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