| CTRI Number |
CTRI/2025/10/095883 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Warm, Buffered Articaine and Buffered Articaine for buccal infiltration of Primary tooth for Pulp therapy procedures: A split mouth design clinical trial. |
|
Scientific Title of Study
|
Comparative evaluation of warm, buffered articaine vs buffered articaine for buccal infiltration of primary tooth for pulp therapy procedures: a split mouth design 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 |
Devadhakshayani V |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka missions sankarachariyar dental college |
| Address |
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road,Ariyanoor
Salem TAMIL NADU 636308 India |
| Phone |
9791997480 |
| Fax |
|
| Email |
devadhakshayani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrVeena Arali |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor
Salem TAMIL NADU 636308 India |
| Phone |
8355803238 |
| Fax |
|
| Email |
empendurkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrVeena Arali |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental College |
| Address |
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor
Salem TAMIL NADU 636308 India |
| Phone |
8355803238 |
| Fax |
|
| Email |
empendurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor |
|
|
Primary Sponsor
|
| Name |
Devadhakshayani V |
| Address |
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road,Ariyanoor |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Devadhakshayani V |
Vinyaka Missions Sankarachariyar Dental College |
Department Number: 6 Department Of Pediatric and Preventive Dentistry Vinayaka missions Sankarachariyar Dental College NH 47 Sankari Main Road, Ariyanoor Salem TAMIL NADU |
9791997480
devadhakshayani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of VMS Dental College Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DENTAL TREATMENT |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buffered articaine |
1.8 ml 0f Articaine will be taken 0.18 ml will be taken out and 0.18 ml of sodium bicarbonate will be added and will be given as buccal infiltration for one time for 1minute |
| Intervention |
warm buffered articaine |
1.8 ml 0f Articaine will be taken 0.18 ml will be taken out and 0.18 ml of sodium bicarbonate will be added and the buffered articaine will be warmed using baby bottle warmer and will be given as buccal infiltration for one time for 1minute |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children exhibiting Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive)
Children with bilateral deep caries with pulpal exposure
Class I and class II relying on ASA classification
|
|
| ExclusionCriteria |
| Details |
Considerable behavior problems
Children with systemic conditions
Parents who refuse to participate in the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identify which method of Local Anesthetic administration is less painful using Wong bakers pain scale at baseline |
Before Administration Of LA
during Administration of LA
At baseline after administration of LA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
24/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pain management is an
extremely important step in behaviour management of children in pediatric dental practice. Local anesthesia (LA) is the transient loss of sensation
in a specific area of the body caused by the depression of nerve ending
excitation or inhibition of conduction in the peripheral nerves. Although local
anesthetic injections cause pain and anxiety in children, they are an integral
part of dental treatment for comfortable, cooperative, and pain-free dental
treatment. The site and speed of injection and the pH of the anesthetic
solution have all been linked to pain during LA administration. Various techniques
have been suggested to alleviate pain during injection. Warming the local
anaesthetic solution to a body temperature found to be effectively reducing
pain during dental procedures.
Another
technique to reduce pain is neutralization of the pH of a LA solution by
buffering with sodium bicarbonate immediately before injection which also
shortens the onset time and improve the clinical efficacy of LAs. While
lidocaine has been the gold standard local analgesia for past many years there
are other effective agents like articaine has become increasingly popular in
dentistry. Articaine hydrochloride is an amide type of local analgesia. It acts
in similar way to other amide analgesia but its unique chemical structure
offers advantages over traditional amide analgesia’s. Articaine is the only
amide analgesia’s to contain an ester group and this allows it to be rapidly
broken down to its inactive state thus decreasing systemic toxicity. Articaine
is more lipid soluble and more potent thereby enabling it to diffuse more
readily through both hard and soft tissues, making it 1.5times more potent than
lidocaine.
Articaine 4%
1:100,000 is reported to be well tolerated, safe and effective local analgesia
for use in children. A literature search found that no studies have been conducted on
the comparison of buffered and warmed articaine with buffered articaine.
The aim of
this study is to evaluate and compare the efficacy of warm and buffered
articaine with buffered articaine in the pulp therapy of a primary teeth.
AIM To determine the anesthetic effect of warm and
buffered articaine with buffered articaine in pulp therapy of a primary
teeth
OBJECTIVES To evaluate the anesthetic effect of buffered and warmed
articaine in pulp therapy of a primary teeth
To
evaluate the anesthetic effect of buffered articaine in pulp therapy of a
primary teeth
To
compare the anesthetic effect of buffered and warmed articaine versus buffered
articaine in pulp therapy of a primary teeth.
METHOD
Study design: Clinical
comparative study
Hypothesis: There is no
difference between the anesthetic
effect of warm and buffered articaine and buffered
articaine in pulp therapy of a primary teeth.
Sample size: 34 Children
Source of study: Children
coming to the Department of Pediatric and Preventive Dentistry, VMSDC, Salem.
Duration: 6 months (after ethical
committee clearance)
Study population: A total of 34 children between 6-10
years will be included in this study.
Inclusion criteria
Children aged 6-10 years
Children exhibiting
Frankel’s behavior rating of grade 3 and 4 (Positive and Definitely Positive)
Children with bilateral
deep caries with pulpal exposure
Class I and class II
relying on ASA classification
Exclusion Criteria
Considerable behavior
problems
Children with systemic
conditions
Parents who refuse to
participate in the study. Randomization
An informed consent from the parent visiting the Department of
Pediatric and Preventive Dentistry, VMSDC, Salem will be obtained. The study
participants will be allocated by simple randomization.
Methodology
Participants requiring bilateral
pulpotomy and pulpectomy procedures will be selected. On the first visit the
children will be subjected to a thorough dental checkup, and radiographs of the
offending teeth will be taken. Children with primary teeth on both right and
left sides affected with deep dentinal caries, requiring pulp therapy will be
selected for the study.
Wong Bakers Faces Pain Scale will be shown to the children and make them
familiarized with it.
In the first appointment one side of the mouth will be administered with
a buccal infiltration of warm and buffered articaine and the pain will be
assessed by using Wong Bakers Faces Pain Scale. The physiological parameters
such as pulse and heart rate will be recorded using a pulse oximeter.
In the second appointment after a week the other side of the mouth will
be administered with a buccal infiltration of buffered articaine and the pain
will be assessed by using Wong Bakers Faces Pain Scale.
In order to make a buffered solution 1.7 ml cartridge of 4% articaine
with 1:100000 adrenaline will be used, from which 0.2 ml of anaesthetic
solution will be taken out and it will be replaced with 0.2ml of 8.4% sodium
bicarbonate. The ratio between the dental local anaesthetic and 8.4% sodium
bicarbonate will be 9:1.
Warming of the local anaesthetic solution will be done by thermostatic
heat bath or baby bottle warmer.
Buccal infiltration of articaine will be given
|