| CTRI Number |
CTRI/2025/01/079650 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effective Pain Management for Infected Lower Molars Using a Modified Injection Technique. |
|
Scientific Title of Study
|
Modified Akinosi Technique: Increasing the success of pulpal anaesthesia for mandibular molars. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Modified Akinosi Technique for Pulpal anesthesia |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarti A Bohora |
| Designation |
Professor |
| Affiliation |
SMBT IDSR DHAMANGAON NASIK |
| Address |
Department of Conservative Dentistry & Endodontics, Room no 201, SMBT Institute of Dental Sciences and Reserach, Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
7020054267 |
| Fax |
00 |
| Email |
draab.endo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti A Bohora |
| Designation |
Professor |
| Affiliation |
SMBT IDSR DHAMANGAON NASIK |
| Address |
Department of Conservative Dentistry and Endodontics, Room No. 201, SMBT Institute of Dental Sciences and Research, Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
7020054267 |
| Fax |
00 |
| Email |
draab.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti A Bohora |
| Designation |
Professor |
| Affiliation |
SMBT IDSR DHAMANGAON NASIK |
| Address |
Department of Conservative Dentistry and Endodontics, Room No. 201, SMBT Institute of Dental Sciences and Research, Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
7020054267 |
| Fax |
00 |
| Email |
draab.endo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Room No. 201, SMBT Institute of Dental Sciences and Research, Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik - 422403, Maharashtra |
|
|
Primary Sponsor
|
| Name |
SMBT Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics, Room No. 201, SMBT Institute of Dental Sciences and Research, Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik - 422403, Maharashtra |
| 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 AARTI BOHORA |
SMBT IDSR |
Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
Nashik
MAHARASHTRA |
07020054267
draab.endo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SMBT IDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human subjects reporting to the department with irreversible pulpitis in mandibular molar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified akinosi technique comapred to inferior alveolar nerve block |
The study will involve 80 clinically healthy patients diagnosed with symptomatic irreversible pulpitis of mandibular first and second molars, with endodontic treatments performed in a single visit. Written informed consent was obtained from each subject. The patients will be randomly allocated into two groups, namely, group A for standard Inferior alveolar nerve block and group B for Modified Akinosi Technique, by coin flip method. For group B (40 patients), anesthesia will be achieved with the Modified Akinosi Technique. Pain levels will be recorded with visual analog scale at the conclusion of each phase of the endodontic treatment. The three phases of endodontic treatment will be as follows, Phase 1: access cavity preparation; Phase 2: working length determination; and Phase 3: root canal preparation. The Modified Akinosi Technique will be deemed successful when all the root canal treatments will be completed without any supplemental anesthesia. |
| Comparator Agent |
Standard Inferior Alveolar Nerve Block as control group |
The study will involve 80 clinically healthy patients diagnosed with symptomatic irreversible pulpitis of mandibular first and second molars, with endodontic treatments performed in a single visit. Written informed consent was obtained from each subject. The patients will be randomly allocated into two groups, namely, group A for standard Inferior alveolar nerve block and group B for Modified Akinosi Technique, by coin flip method.
For group A, containing 40 patients, local anesthesia will be achieved with standard inferior nerve block technique. Pain levels will be recorded with visual analog scale at the conclusion of each phase of the endodontic treatment. The three phases of endodontic treatment will be as follows, Phase 1: access cavity preparation; Phase 2: working length determination; and Phase 3: root canal preparation. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
80 patients will be selected from among the patients reporting to the Department of Conservative Dentistry and Endodontics, in a randomized clinical trial study design.
The study will include patients aged between 16 and 65 years of both genders. patients diagnosed with symptomatic irreversible pulpitis in their mandibular first and second molars indicated for single-visit endodontic treatment will be included.
|
|
| ExclusionCriteria |
| Details |
Patients with active infections, swelling, or abscesses. Cases involving open apices, calcified canals, or retreatment will be excluded. Additionally, patients with systemic diseases where the administration of local anesthesia is contraindicated, and immunocompromised, and those who failed to provide consent will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attainment of adequate anesthesia that allowed root canal therapy to be completed without any additional need of anesthesia |
Pain levels will be recorded with visual analog scale at the conclusion of each phase of the endodontic treatment: Phase 1: access cavity preparation; Phase 2: working length determination; and Phase 3: root canal preparation. Pain outcomes will be assessed at baseline. The Modified Akinosi technique will be deemed successful when all root canals could be completed without any supplemental anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The MAT is underutilized but can offer effective anesthesia with several advantages, including reduced patient apprehension, minimal pain, fewer complications, ease of performance. |
The pain levels will be recorded at baseline as Pain levels will be recorded with visual analog scale at the conclusion of each phase of the endodontic treatment: Phase 1: access cavity preparation; Phase 2: working length determination; & Phase 3: root canal preparation. The Modified Akinosi technique will be deemed successful when all root canals could be completed without any supplemental anesthesia. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
17/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draab.endo@gmail.com].
- For how long will this data be available start date provided 10-12-2024 and end date provided 03-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A total of 80 clinically healthy patients of both genders, between 16 and 65 years, diagnosed with symptomatic irreversible pulpitis in mandibular first and second molars will be included in the study. The subjects will be divided into two groups. Group A will receive nerve block and pulpal anesthesia through Inferior Alveolar Nerve Block technique, while Group B receive nerve block through Modified Akinosi technique with 2% lignocaine containing 1:200,000 adrenaline. All endodontic treatments will be performed in a single visit. We will evaluate the presence of pain during various phases of endodontic treatment with Visual Analog Scale. The pain level will be registered at the end of the following phases of the endodontic treatment: 1. During access cavity preparation; 2. While determining working length for all the root canals; 3. During cleaning and shaping of root canals. |