| CTRI Number |
CTRI/2024/10/075265 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of different combinations of Calcium Hydroxide as intra canal medicament on pain after the treatment in patients with symptomatic apical periodontitis. |
|
Scientific Title of Study
|
Effect of Various Calcium Hydroxide Combinations as Intracanal medicament for Managing Post-Operative Pain in Symptomatic Apical Periodontitis Cases: A Double Blinded 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 |
Dr. ANNEYSHA BHATTACHARRYA |
| Designation |
MDS (Postgraduate student) |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge park 3
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
7338102112 |
| Fax |
|
| Email |
anneyshabhattacharyya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, Greater Noida |
| Address |
Room no.7, Department of Conservative Dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge park 3
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, Greater Noida |
| Address |
Room no.7, Department of Conservative Dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge park 3
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge park 3, Greater Noida - 201308, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
I.T.S. Dental College Hospital and Research Centre |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANNEYSHA BHATTACHARYYA |
I.T.S DENTAL COLLEGE, Greater Noida |
Room no.7, Department of Conservative Dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge park 3
Gautam Buddha Nagar
UTTAR PRADESH |
7338102112
anneyshabhattacharyya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental college hospital and research centre institutional ethics committee |
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 |
calcium hydroxide mixed with dexamethasone as vehicle |
Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be established 1mm from radiographic apex and will be confirmed with peri-apical radiographs. The apical portion of canal will be enlarged using K-files to size 3-4 files larger than the initial apical file, and the rest of the canal will be prepared using the crown down technique of canal preparation. Calcium hydroxide will be mixed with Dexamethasone Phosphate 4mg/1ml
(0.12 g powder plus 0.14 mL liquid). It will be placed in the canal with lentulo spiral for one week, and the tooth will be temporised with cavit.The endodontic treatment will be completed after a week. |
| Intervention |
calcium hydroxide mixed with lidocaine as vehicle |
Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be established 1mm from radiographic apex and will be confirmed with peri-apical radiographs. The apical portion of canal will be enlarged using K-files to size 3-4 files larger than the initial apical file, and the rest of the canal will be prepared using the crown down technique of canal preparation. Calcium hydroxide will be mixed with 20 mg/ml Lidocaine with 0.0125 mg/ml epinephrine ( 0.12 g powder plus 0.14 mL liquid). It will be placed in the canal with lentulo spiral for one week, and the tooth will be temporised with cavit.The endodontic treatment will be completed after a week. |
| Comparator Agent |
calcium hydroxide mixed with saline as vehicle |
Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be established 1mm from radiographic apex and will be confirmed with peri-apical radiographs. The apical portion of canal will be enlarged using K-files to size 3-4 files larger than the initial apical file, and the rest of the canal will be prepared using the crown down technique of canal preparation. Calcium hydroxide will be mixed with Saline (0.9 % NaCl)
(0.12 mg powder plus 0.14 mL liquid). It will be placed in the canal with lentulo spiral for one week, and the tooth will be temporised with cavit.The endodontic treatment will be completed after a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular molar teeth with symptomatic apical periodontitis with either irreversible pulpitis or necrotic pulp.Patients with preoperative pain on percussion with 50 mm or above on a visual analogue scale (VAS) scale
Age 18-65 years.
Teeth with PAI scores 1 and 2 described by Orstavik et al. |
|
| ExclusionCriteria |
| Details |
Patients on preoperative analgesics and antibiotics within past month.
Presence of periodontal pockets more than 3 mm, sinus tract or swelling in the associated tooth
Severely damaged teeth; teeth with root resorption; root fracture or ankylosis, bruxism.
Root canal treated tooth
Immunocompromised patients, pregnant and lactating mothers
Patients who are older than 65 years old |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is to compare and evaluate pain reduction in patients with apical periodontitis using different combinations of calcium hydroxide with saline, lidocaine and dexamethasone. |
after every 24 hours for one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find any difference in pain reduction on using different vehicles with calcium hydroxide as intra canal medicaments. |
at 2 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A total number of 45 patients reporting to the O.P.D. will be selected according to inclusion and exclusion criteria.Root canal treatment will be initiated under local anesthesia and rubber dam isolation. Working length will be established 1mm from radiographic apex and will be confirmed with peri-apical radiographs. The apical portion of canal will be enlarged using K-files to size 3-4 files larger than the initial apical file, and the rest of the canal will be prepared using the crown down technique of canal preparation. The patients will be randomly categorized into three groups The dentist and the patient will be blinded during allocation of patients to various groups. GROUP A (n=15) Calcium hydroxide + Saline (0.9 % NaCl) 0.12 mg powder plus 0.14 mL liquid GROUP B (n=15) Calcium hydroxide + 20 mg/ml Lidocaine with 0.0125 mg/ml epinephrine 0.12 g powder plus 0.14 mL liquid GROUP C (n=15) Calcium hydroxide + Dexamethasone Phosphate 4mg/1ml 0.12 g powder plus 0.14 mL liquid It will be placed in the canal with lentulo spiral for one week, and the tooth will be temporised with cavit.The endodontic treatment will be completed after a week. The patient will be advised to mark at the VAS scale after every 24 hours for 7 days. If patient complains of pain they will be prescribed a combination drug of Acelofenac (100mg), paracetamol (325mg), and Serratiopeptidase (15mg) as an escape drug They will be asked to keep a record of analgesics taken each day. Patients will be recalled after 1 week for completion of the treatment
|