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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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