| CTRI Number |
CTRI/2025/01/079023 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Compare the Efficacy Of Preoperative Use Of Enzyme & Anti-Oxidant Based Painkiller Over A Plain Painkiller On The Nerve Block And Postoperative Pain Control In Root Canal Treatment Of Infected Molars. |
|
Scientific Title of Study
|
Comparative Efficacy Of Pre-Emptive Use Of Enzyme & Anti-Oxidant Based NSAID Over Plain NSAID On Inferior Alveolar Nerve Blockade And Postoperative Pain Control In Endodontic Treatment Of Molars With Symptomatic Pulpitis: A Randomized Controlled Clinical 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 S Srija Mili |
| Designation |
PG Student |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Hyderabad TELANGANA 500055 India |
| Phone |
08897300388 |
| Fax |
|
| Email |
ssmili401@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Swathi |
| Designation |
HOD, Proffesor |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Hyderabad TELANGANA 500055 India |
| Phone |
09866021672 |
| Fax |
|
| Email |
drswathi.endo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Srija Mili |
| Designation |
PG Student |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. Hyderabad TELANGANA 500055 India |
| Phone |
08897300388 |
| Fax |
|
| Email |
ssmili401@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055, INDIA. |
|
|
Primary Sponsor
|
| Name |
Malla Reddy Dental College for Women |
| Address |
Malla Reddy Dental College for Women,Venkatarama Colony, Suraram, Hyderabad, Telangana 500055 |
| 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 S Srija Mili |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama Colony, Suraram, Hyderabad, Telangana 500055. Hyderabad TELANGANA |
08897300388
ssmili401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MALLA REDDY DENTAL COLLEGE FOR WOMEN INSTITUITIONAL 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, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac sodium. |
Diclofenac sodium 50mg to be given orally 60 minutes before the endodontic treatment. |
| Intervention |
Enzyme and Antioxidant based NSAID. |
Composed of Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg to be given orally 60min before the endodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Mandibular molars diagnosed with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
2. Had not taken any type of analgesic medication within the previous 12 h.
3. The absence of periapical radiolucency on radiographs, except for a widened periodontal ligament.
|
|
| ExclusionCriteria |
| Details |
1. Patients allergic to diclofenac, bromelain, rutoside, trypsin, lidocaine or any other medication/ material used in study.
2. Diabetic, Hypertensive, Smoking, Pregnant or lactating women.
3. Any endocrine or infectious disease or had any systemic disease that contraindicate endodontic therapy.
4. Teeth with periodontal disease, necrotic tooth.
5. Radiographic images suggestive of internal or external resorptions.
6. Endodontic treatments not completed in a single session.
7. Failed to achieve adequate anesthesia (IANB).
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID as preoperative medication on the success of Inferior Alveolar Nerve Block.
|
NRS pain scale scored from 0 to 10, taken 15 minutes after the Inferior Alveolar Nerve Block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the influence of the Enzyme and Antioxidant based NSAID as preoperative medication on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. at 6, 12, 24 and 48 hours.
|
NRS pain scale scored from 0 to 10 at 4 intervals i.e. at 6, 12, 24 and 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="87" Sample Size from India="87"
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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
|
Pain management during and after endodontic treatment is essential for both clinicians and patients. Thus, effective anesthesia and minimal postoperative pain is always considered to be of utmost importance during an endodontic treatment. Inferior alveolar nerve block (IANB) is preferred anesthetic technique for endodontic treatment of mandibular molars. However, success rate of IANB is quite low in patients with symptomatic irreversible pulpitis (SIP) in mandibular molars, ranging from 58% to 79%. Anesthetizing tooth with irreversible pulpitis poses a challenge as the voltage-gated sodium channels are resistant to local anesthetic relatively. Anatomical variations, pulpal inflammation, failure of anesthetic technique and even anxiety caused by preoperative pain can explain anesthetic difficulty. In postoperative period following an endodontic procedure, approximately 47% of patients report moderate to severe pain, with a higher incidence between 6 and 24 h. The inflammatory process of the pulp involves pro-inflammatory chemical mediators, mainly prostaglandins, which have been shown to cause hyper-algesic effects in addition to inflammatory process. Although periapical inflammation has a significant influence on occurrence of postoperative pain, the presence of excruciating symptoms in preoperative period is one of the factors that can contribute to an increase in pain score. This study is an attempt to check whether additional factors like Bromelain, Trypsin (ENZYMES) and Rutoside trihydrate (ANTIOXIDANT) provide a synergistic action to the NSAID in pain control which indirectly provides its efficacy over nerve blockade. In the literature we have many studies proving the potency of various NSAIDs over the IANB success and postoperative pain, but there is a paucity of studies investigating an enzyme and antioxidant based NSAID’s efficacy over IANB success and pain control in endodontically treated molars, which forms the basis of this study research. The aim of the study is to compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID (Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg) and plain NSAID (Diclofenac sodium 50mg) as preoperative medication which is given 60 min before initiating the endodontic treatment and to assess its effect on the success of Inferior Alveolar Nerve Block, and to evaluate the influence of these drugs on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. 6, 12, 24 and 48 hours. |