| CTRI Number |
CTRI/2024/06/068397 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| 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 how well two different treatments reduce pain after surgery in patients with severe tooth inflammation: one treatment uses low-level laser therapy, and the other uses a standard method with oxidized water. This was done through a randomized clinical trial. |
|
Scientific Title of Study
|
Comparative evaluation of Postoperative Pain In Patients of Symptomatic Irreversible Pulpitis with Low-Level Laser Therapy And Conventional Irrigation Technique Using Oxidized Water As An Irrigant : A Randomized clinical Control 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 Palak Hirani |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 1st Floor Dept of conservative dentistry and endodontics SPDC Datta Meghe Institute of higher education and research Sawangi Meghe
Wardha
MAHARASHTRA
442201
India |
| Phone |
09179174182 |
| Fax |
|
| Email |
palakhirani13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Chandak |
| Designation |
Dean and Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 1st Floor Dept of conservative dentistry and endodontics SPDC Datta Meghe Institute of higher education and research Sawangi Meghe
Wardha
MAHARASHTRA
442201
India |
| Phone |
9822693276 |
| Fax |
|
| Email |
drmanojchandak@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Chandak |
| Designation |
Dean and Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 1st Floor Dept of conservative dentistry and endodontics SPDC Datta Meghe Institute of higher education and research Sawangi Meghe
Wardha
MAHARASHTRA
442201
India |
| Phone |
9822693276 |
| Fax |
|
| Email |
drmanojchandak@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha India 442201 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
DMIHER Sawangi Meghe Wardha 442201 |
| Type of Sponsor |
Private medical college |
|
|
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 Palak Hirani |
Sharad Pawar Dental College |
103 Dept of Conservative Dentistry and Endodontics SPDC Building, Datta Meghe Institute of higher education and research Sawangi Meghe 442201
Wardha
MAHARASHTRA |
09179174182
palakhirani13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Root canal irradiation using oxidized water with a diode laser reduce Post Poperative Pain after RCT in single-rooted teeth |
Penetration of Irrigant Solution via low level laser activation techniques into Dentinal Tubules and assessing post operative pain.
It would be compared after irrigation and post operative pain will be evaluated after 24 hrs and healing after 3 months. |
| Comparator Agent |
Root canal irradiation using sodium hypochlorite with a diode laser reduce Post operative Pain after RCT in single-rooted teeth |
Penetration of Irrigant Solution via low level laser activation techniques into Dentinal Tubules and assessing post operative pain. Gold Standard Sodium Hypochlorite would be compared with oxidised water after irrigation and post operative pain will be evaluated after 24 hrs and healing after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
- Patients included in this study will be in the age range of 18 - 40 years
- Will be having single-rooted permanent tooth with closed apex.
- The selected patients will be without known allergic reactions to any of the antibiotics used or systemic disease.
|
|
| ExclusionCriteria |
| Details |
- Patients with Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases & Cancer.
- Patients on Long term Corticosteroid therapy.
- Patients with immunocompromised status.
- Pregnant and Lactating females.
- Patients with generalized chronic periodontitis.
- Patients having non-restorable teeth.
- Teeth with previous root canal treatment.
- Teeth with developmental anomalies.
- Teeth with external and internal resorption.
- Teeth with calcified canals
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Root canal irradiation with a diode laser reduce Post operative Pain after RCT in single-rooted teeth |
14 samples of intervention group and 14 samples of comparator group will be compared and evaluated for postoperative pain. Assessment will be done at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
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
|
In root canal therapy, the infected pulp is removed, and the root cavity is disinfected and filled with sealing material. However, if micro-organisms remain, they can cause a periapical lesion. Postoperative endodontic pain (PEP), occurring in 3%-58% of cases, results from elevated inflammatory mediators in periapical tissue, leading to peripheral hyperalgesia. The primary cause of PEP is the extrusion of microorganisms and their byproducts during treatment. Low Level Laser Therapy (LLLT) has been shown to have anti-inflammatory and pain-relieving effects through photo-biomodulation, which modifies pain thresholds, reduces bradykinin and histamine release, enhances endogenous endorphin production, and alters prostaglandin synthesis. LLLT operates at wavelengths between 600 and 1000 nm, with a power range of 0.005 to 0.5 Watt and a power density below 670mW/cm2. Oxidative potential water (OPW), known for its safety and bactericidal effectiveness, contains reactive oxygen species and has a neutral pH. It destabilizes bacterial cell walls without harming host tissues. While sodium hypochlorite followed by EDTA has been the gold standard for irrigation, its caustic effects and collagen degradation pose challenges. OPW, in combination with LLLT, could offer a safer and more effective irrigation protocol, potentially reducing postoperative pain and improving root canal treatment outcomes |