CTRI

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CTRI Number

CTRI/2018/02/011685 [Registered on: 05/02/2018] Trial Registered Retrospectively

Last Modified On:

05/02/2018

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Dentistry

Study Design

Randomized, Crossover Trial

Public Title of Study

Effect of adding Dexamethasone to Anaesthesia to improve pain control for fillings.

Scientific Title of Study

A Prospective Randomized Double Blind Clinical Trial to Assess the Efficacy of Twin Mix and Lidocaine on Inferior Alveolar Nerve Block.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Mamta Kaushik
Designation	Professor and Head
Affiliation	Army College of Dental Sciences
Address	Deparment of Conservative Dentistry and Endodontics Room no 9 Army College of Dental Sciences Jai Jawahar Nagar CRPF-Chennapur road Secunderabad Rangareddi ANDHRA PRADESH 500087 India
Phone
Fax
Email	mamkaushik@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Mamta Kaushik
Designation	Professor and Head
Affiliation	Army College of Dental Sciences
Address	Deparment of Conservative Dentistry and Endodontics Room no 9 Army College of Dental Sciences Jai Jawahar Nagar CRPF-Chennapur road Secunderabad Rangareddi ANDHRA PRADESH 500087 India
Phone
Fax
Email	mamkaushik@gmail.com

Details of Contact Person
Public Query

Name	Dr Mamta Kaushik
Designation	Professor and Head
Affiliation	Army College of Dental Sciences
Address	Deparment of Conservative Dentistry and Endodontics Room no 9 Army College of Dental Sciences Jai Jawahar Nagar CRPF-Chennapur road Secunderabad Rangareddi ANDHRA PRADESH 500087 India
Phone
Fax
Email	mamkaushik@gmail.com

Source of Monetary or Material Support

Army College of Dental Sciences Secunderabad 500087 Telangana, India

Primary Sponsor

Name	Dr Mamta Kaushik
Address	Department of Conservative Dentistry and Endodontics Army College of Dental Sciences Jai Jawahar Nagar Secunderabad
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
Dr Mamta Kaushik	Army College of Dental Sciences	Deparment of Conservative Dentistry and Endodontics Room no 9 Army College of Dental Sciences Jai Jawahar Nagar CRPF-Chennapur road Secunderabad Rangareddi ANDHRA PRADESH	9391010325 mamkaushik@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	having healthy teeth with no periodontal condition and having first molar, first premolar and lateral incisor present

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Lidocaine with epinephrine	1.8 ml of 2% Lidocaine with 1:200000 Epinephrine as an injection of Inferior Alveolar Nerve Block
Intervention	Twin mix	1ml of 4mg Dexamethasone in 2% Lidocaine with 1:200000 Epinephrine will be administered as an injection of Inferior Alveolar Nerve Block

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1. Age: 18-55 years 2. Currently not feeling pain 3. Good health 4. Not taking any medication that would alter the perception of pain determined by verbal questioning and written questionnaire. 5. Having the first molar, First Premolar and Lateral incisor present

ExclusionCriteria

Details

1. Having Pain or irreversible pulpitits
2. Existence of acute infection and/or swelling
3. Systemic disorders
4. History of complications associated with LA

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Twin mix may prove to be effective for pulpal anaesthesia in Inferior Alveolar nerve blocks in healthy teeth	15 minutes

Secondary Outcome

Outcome	TimePoints
twin mix may prove more effective than lidocaine in pulpal anaesthesia in mandibular teeth	15 minutes to 60 minutes

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30"

Phase of Trial

N/A

Date of First Enrollment (India)

01/08/2017

Date of Study Completion (India)

04/09/2017

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="1"
Days="4"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

none

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Achieving successful pulpal anaesthesia in healthy mandibular teeth is a challenge for the practitioner, with a success rate of 51-65% . There have been multiple suggestions to improve the anaesthesia:

1. Supplementary anaesthesia â€“

Intraligamentary

Intraosseous

Intrapulpal

2. buccal infiltrations of articaine, ketarol, dexamethasone

3. Premedication with analgesics and steroids ( Ibuprofen, Ketarol, Dexamethazone )

Use of steroid as oral, parental and submucosal routes has been extensively studied in third molar impaction surgeries.

One method of delivery suggested is mixing the steroid in the LA solution â€“ TWIN MIX

This mixture has been extensively studied and found to be very effective in third molar extractions.

The efficacy in teeth with pulpal anaesthesia has not been studied.

The aim of this study is to assess the anaesthetic efficacy of twin mix for achieving successful pulpal anaesthesia when used in IANB, and in healthy pulp.