| CTRI Number |
CTRI/2024/11/076836 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study of poat operative pain using laser and N acetyle cystiene after endodontic therapy |
|
Scientific Title of Study
|
Comparative evaluation of the effect of 970 nm diode laser with or without N acetyl cysteine on post operative pain after endodontic treatment in teeth with symptomatic apical periodontitis: a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JOE PAUL UMMBAVU |
| Designation |
PG student |
| Affiliation |
Bapuji Dental College and hospital |
| Address |
department no 6 , conservative dentistry and endodontics , bapuji dental college and hospital ,MCC B block , Davangere
Davanagere KARNATAKA 577004 India |
| Phone |
9483210494 |
| Fax |
|
| Email |
joepaul82@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr RASHMI N C |
| Designation |
professor |
| Affiliation |
Bapuji Dental College and hospital |
| Address |
department 6, department of conservative dentistry and endodontics, Bapuji Dental College and Hospital , MCC B block , Davangere
Davanagere KARNATAKA 577004 India |
| Phone |
7347228077 |
| Fax |
|
| Email |
ncrashmi@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
JOE PAUL UMMBAVU |
| Designation |
PG student |
| Affiliation |
Bapuji Dental College and hospital |
| Address |
Department 6 department of conservative dentistry and endodontics ,Bapuji Dental College and hospital , MCC B block , Davangere , 577004 , Karnataka
Davanagere KARNATAKA 577004 India |
| Phone |
9483210494 |
| Fax |
|
| Email |
joepaul82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and hospital ,MCC B block , Davangere , Karnataka , India , 577004 |
|
|
Primary Sponsor
|
| Name |
Joe Paul Umbavu |
| Address |
DENTAL COLLEGE BOYS HOSTEL , BOYS HOSTEL ROAD , MCC B BLLOCK ,DAVANGERE , KARANTAKA , 577004 |
| 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 |
| JOE PAUL UMBAVU |
Bapuji dental college and hospital |
Department 6 , Department of Conservative Dentistry and Endodontics Davanagere KARNATAKA |
9483210494
joepaul82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD , BAPUJI DENTAL COLLEGE AND HOSPITAL , DAVANGERE |
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 |
| Comparator Agent |
970NM diode LASER |
LASER Irradiation carried out after drying the root canal after endodontic therapy, assessment of post operative pain at 8 hr , 24 hr , 48 hr and 72 hr and 7 days |
| Intervention |
970NM diode LASER and N acetyl cystein |
970NM diode LSER irradiation carried out followed by N acetyl cystein intracanal medicament placed ,assesment of post operative pain at 8 hr , 24 hr , 48 hr , 72 hr and 7 days |
| Intervention |
N acetyl cysteine |
N acetyl cysteine used as intracanal medicament ,after drying the root canal after endodontic therapy, assessment of post operative pain at 8 hr , 24 hr , 48 hr and 72 hr and 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with mandibular molar with symptomatic apical periodontitis
2. Periapical index up to 3 or 4.
3. Patient older than 18 to 60 years
4. Spontaneous pain <3mm
5. Percussion pain <3mm
|
|
| ExclusionCriteria |
| Details |
• Periodontal probing greater than 3mm
• Previous root canal treatment
• Swelling / sinus tract
• Sever periodontal disease
• Antibiotic use within last 5 days
• Systemic disorders
• Pregnancy and lactation
• Traumatic occlusion
• Severe crown destruction preventing rubber dam isolation
• Presence of other teeth requiring RCT
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain assessment after root canal treatment |
pre operative pain assessment
post operative pain assessment at 8 hr after root canal treatment
post operative pain assessment at24 hr after root canal treatment
post operative pain assessment at48 hr after root canal treatment
post operative pain assessment at72 hr after root canal treatment
post operative pain assessment at 7DAY after root canal treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain comparison among individuals of different age & gender |
preoperative pain , post operative pain 8hr , post operative pain 24hr , post operative pain 48 hr , post operative pain 72 hr
post operative pain after 7 days after root canal treatment |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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="0" Months="1" Days="5" |
|
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
|
METHODOLOGY
Mandibular
block anesthesia performed using local anesthetics solution 1.8ml 2%
lidocaine with 1:80000 epinephrine. The procedure started after lip numbness was
achieved. Occlusal reduction will be done followed by straight-line access cavity and the procedure was completed under rubber
dam isolation. The working length was determined using an electronic apex
locator (J morita), and Endomotor (Canalpro cl2i ,Coltene ,India) , Protaper
gold (Dentsply Maillefer, Ballaigues,
Switzerland) was used according to the
manufacturer’s instructions for cleaning and shaping .
A size 10 K-file
was used to maintain apical patency, 2 mL 2.5% sodium hypochlorite was used
between in-and-out pecking motions, and After instrumentation, The needle was advanced to a depth of 2–3 mm short
of WL and the
canal will be irrigated with 3 mL of
2.5% NaOCl. Final irrigation will be done with 5 mL of 17% EDTA for 1 min followed by a final rinse
with 5ml of saline.
Randomization
After that, patients were randomly assigned to one
of the three groups based on the post operative therapy
ROOT CANAL INSTRUMENTATION
The patients will
be randomly divided
into 3 groups containing teeth in
each group
namely:
§ GROUP I(n=20): N acetyl cysteine
§ GROUP II(n=20) : 970 nm diode laser
§ Group II(n=20): 970 nm diode laser + N acetyl cysteine
Group I :
After the canals
are dried with paper point N acetyl cysteine
paste was applied as intra-canal medicament , and the access cavity
was sealed using a temporary restorative material
GROUP II:
The final
irrigation was performed , after the canals were dried with paper-points.
During the laser treatment, both the operator and patient wore protective
eyewear. Laser irradiation was applied using a 970-nm diode laser (Sirolaser
blue , Dentsply Maillefer, Ballaigues, Switzerland) coupled with a 200-μm
optical fibre. The settings were as follows: output power of 1.5 W in the
pulsed mode irradiation for 10 s, followed by a 10-s pause, which comprised
one cycle. This cycle was applied four times to each root canal. The power used was 1.5 W with a low frequency of 15 Hz. The optical
fibre tip (length of 25 mm) was inserted at the working length. The root
canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to
coronal using a continuous circling movement touching the dentinal walls in
one cycle for each power. and the access cavity was sealed using a temporary
restorative material.
GROUP III:
The final
irrigation was performed as in the control group, and the canals were dried
with paper points. During the laser treatment, both the operator and patient
wore protective eyewear. Laser irradiation was applied using a 970-nm diode
laser (sirolaser blue Dentsply Maillefer, Ballaigues, Switzerland ) coupled
with a 200-μm optical fibre .The settings were as follows: power of 1.5 W and
in the pulsed mode , irradiation for 10 s, followed by a 10-s pause, which
comprised one cycle. This cycle was applied four times to each root canal.
The power used was 1.5 W with a low frequency of 15 Hz. The optical fibre tip
(length of 25 mm) was inserted at the working length. The root canals were
then slowly (at a speed of 2 mm/s) irradiated from the apical to coronal
using a continuous circling movement touching the dentinal walls in one cycle
for each power.
Following the
irradiation procedure, N acetyl cysteine paste was applied as intra-canal medicament ,
and the access cavity was sealed using a temporary restorative material, as
in the control group
Subsequently, a
temporary restorative material (Cavit-G; 3 M ESPE, St Paul, MN) was used to
seal the access cavity.
At the time of
the first visit, all the patients were given a VAS to rate their PP. A second
appointment was scheduled for 7 d later. All patients who met the final inclusion criteria
were given a pain chart to be
completed to record the incidence of pain (yes/no), level of posttreatment
pain and duration of pain (days). They were asked to submit the forms after 1
week. Patients have been prescribed an optional medication of ibuprofen (400
mg, 8–12 h). Patients were asked to record the information if they took the
medication. A modified visual analogue scale (VAS) was employed for assessment
and statistical comparison of pain scores: score 0, absolutely nothing;
scores 1–3 (mild), very weak discomfort or mild pain but requiring no
intervention and not influencing ordinary activities of daily life; does not
require analgesics; scores 4–6 (moderate), moderate pain which is distracting
for the patient and occasionally negatively influences the patient from
performing his normal daily activities; the pain is relieved with analgesics;
scores 7–10 (severe), this score range covered very severe and extremely
severe/ unbearable pain that forces the patient to give up his/her daily
activities and needs rest; this pain is not relieved by analgesics. (11)
The patients were
instructed to use 400 mg ibuprofen (Brufen; Abbott, Latina, Italy) if the
pain was unbearable and asked to record analgesic intake. The patients
recorded their pain experience on a customized form, which was also used to
record any analgesic intake.
The following
variables were recorded:
1. Age
2. Sex
3. Tooth number
4. Number of canals
6. Preoperative
pain on the VAS
7. Preoperative
and postoperative percussion pain levels (on the 7th day) on the
VAS
8. Pain level on
the 8 hr ,24 hr, 48hr , 72hr & 7 day
11. Analgesic
intake after the procedure
|
At the second appointment, the ICM was removed from
the root canals with final irrigation and using an F3/F2 file. The root canals
were then obturated using the cold lateral condensation method with
gutta-percha cones and AH Plus sealer (Dentsply Maillefer, Ballaigues,
Switzerland). The coronal restoration was finished using a resin composite
(Filtek Z250, 3 M ESPE, St. Paul, MN |