| CTRI Number |
CTRI/2024/06/068367 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To reduce the pain while giving injection in mouth by comparing two techniques. |
|
Scientific Title of Study
|
Acupressure vs topical gel as preanesthetic technique in children A split mouth 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 |
NIDHI CHAUHAN |
| Designation |
PG Student |
| Affiliation |
SGT University, Budhera, Gurugram,Haryana. |
| Address |
Room No.- 202, Pediatric And Preventive Dentistry, Faculty Of Dental Science, SGT University, Budhera, Gurugram, Haryana.
Gurgaon HARYANA 122505 India |
| Phone |
7297046891 |
| Fax |
|
| Email |
chauhan.nidhi0202@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Anil Gupta |
| Designation |
Head Of Department |
| Affiliation |
SGT University, Gurugram, Haryana. |
| Address |
Room No.- 202, Pediatric And Preventive Dentistry, Faculty Of Dental Science, SGT University, Budhera, Gurugram, Haryana.
Gurgaon HARYANA 122505 India |
| Phone |
9899039805 |
| Fax |
|
| Email |
anil.gupta@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Nidhi Chauhan |
| Designation |
PG student |
| Affiliation |
SGT University, Gurugram, Haryana. |
| Address |
Room No.- 202, Pediatric And Preventive Dentistry, Faculty Of Dental Science, SGT University, Budhera, Gurugram, Haryana.
Gurgaon HARYANA 122505 India |
| Phone |
7297046891 |
| Fax |
|
| Email |
chauhan.nidhi0202@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Nidhi Chauhan
SGT University, Department Of Pediatric And Preventive Dentistry, Faculty Of Dental Sciences, Budhera, Gurugram, Haryana. |
|
|
Primary Sponsor
|
| Name |
Dr Nidhi Chauhan |
| Address |
Room No.- 202, Pediatric And Preventive Dentistry, Faculty Of Dental Science, SGT University, Budhera, Gurugram, Haryana. |
| 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 |
| Dr Nidhi Chauhan |
SGT University Department Of Pediatric And Preventive Dentistry. |
Room No.- 202, Pediatric And Preventive Dentistry, Faculty Of Dental Science, SGT University, Budhera, Gurugram, Haryana. Gurgaon HARYANA |
07297046891
chauhan.nidhi0202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Sgt Dental College, Hospital and REsearch Institute(IEC-SGTDHCRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aculief Acupressure Device. |
Aculief acupressure device attached to LI4 point to reduce pain in needle insertion during local anesthesia to be used in all the 80 cases over a period of 1 year. |
| Comparator Agent |
Topical gel |
Topical gel applied to oral mucosa to reduce needle insertion pain during local anesthesia to be applied in all the 80 cases over a period of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. children who require any pediatric procedure to be done under local anesthesia.
2. Children with no prior experience with local anesthesia.
3. Children with Frankl behavior rating scale grade 3 and 4.
|
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs.
2. Patients with blisters, rashes, open wounds and swelling in and around LI 4 acupressure point.
3. Patients with history of hypersensitivity reactions to anesthetic agents.
4. Recent trauma to oral tissues. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of the study is to evaluate the effect of the aculief acupressure device on
the reduction of during local anesthesia in children and compare it with the topical anesthetic gel. |
After a period of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of the Aculief acupressure device on the reduction of pain during LA in
children using SEM scale & Wong-Bakers FACES Pain Rating scale.
2. To evaluate the effectiveness of topical anesthetic gel on needle insertion pain during
administration of LA using SEM scale & Wong-Bakers FACES Pain Rating scale.
3. To compare & evaluate the effect of the Aculief acupressure device with topical gel during LA
administration. |
Over a period of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
05/06/2025 |
| 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 Yet Recruiting |
| 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
|
Local anesthetic injections are one of the most painful and disturbing dental procedures to be performed during pediatric dental treatment. Administration of local anesthesia (LA) is the first and foremost prerequisite for most invasive procedures in pediatric dentistry. Local anesthesia needs to be deposited as close to the nerve as possible so that optimal diffusion of the drug may occur, providing profound anesthesia and a pain-free dental experience for the kids. The importance of this is demonstrated by the fact that when pediatric patients’ parents were asked to list the most important factors used when selecting an exodontist, the two most important are: a pedodontist who does not hurt and a painless injection. Cooperation of children, using proper pain control method during dental procedures, remains elusive in pediatric dentistry. Effective pain control in children during regional dental injections is important to achieve comfort, cooperation, and compliance with dental care. For a comfortable treatment, it is important to have a pain-free method of administering local anesthesia for a dental patient. Topical anesthetics are an advantage to dentists in their attempts for pain-free injections. Topical anesthetics control pain perception and they have the ability to cross the oral mucosal membrane and produce analgesia. They block the conduction of signals from the terminal fibers of the sensory nerves, thereby producing surface anesthesia for a depth of 2–3 mm. Topical anesthetic gel/ointment is easily available and is not technique sensitive. Hence, topical anesthetic gel/ointment has become the “holy grail†of painless technique of local anesthesia in pediatric dentistry. There are various topical anesthetic agents available ranging from gels to sprays. Benzocaine is most widely used by dentists, and it is rapidly absorbed on the mucosal membrane. It is less soluble in water and is long acting with less toxicity. Topical benzocaine is commercially marketed in 10% and 20% concentrations. So, in today’s era where several methods are available for pain management, acupuncture is also said to be one of the safe and effective method. Acupuncture uses acupressure to relieve blockage in “Qi†pronounced as “chee†and promotes the natural circulation of energy throughout the body. Stimulation of acupressure point LI4, also known as Hegu point, has been seen to provide an analgesic and antianxiety effect in the orofacial region, according to studies, thus decreasing pain in the region. It has been used as a substitute therapeutic procedure to control pain in dentistry, including facial pain, migraine, tension headaches, and dental pain. Aculief is a wearable acupressure device which is available in the market as Aculief wearable acupressure. It is a manual acupressure device that is designed in the form of a clip to cause pressure on the LI4 point. It is easy to use, and there are no related side effects. Aculief has been in use as an acupressure device to relieve headaches and migraines in studies. So, taking into consideration the advantages of topical gel and acupressure device, we plan to evaluate the effect of acupressure device vs. topical gel as pre-anesthetic technique in children. |