| CTRI Number |
CTRI/2024/05/068109 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing laser therapy as topical anesthesia alternative in grade III mobile tooth extraction : An Observational Study |
|
Scientific Title of Study
|
Evaluation of the effectiveness of photobiomodulation therapy as an alternative to topical anesthesia for extraction of physiologically mobile teeth (grade III ) : An Observational 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 |
DR Sandra Maria Enchackal |
| Designation |
Postgraduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya dental college
First floor
Department of pediatric and preventive dentistry
Mangalore
Yenepoya dental college
First floor
Department of pediatric and preventive dentistry
Mangalore
Dakshina Kannada
KARNATAKA
575017
India |
| Phone |
9446628911 |
| Fax |
|
| Email |
98sandramariaenchackal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Suvarna |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of pediatric and preventive dentistry
Yenepoya Dental College
Deralakatte,Manglore
KARNATAKA
575017
India |
| Phone |
9844513258 |
| Fax |
|
| Email |
drreshmasuvarna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sandra Maria Enchackal |
| Designation |
Postgraduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya dental college
First floor
Department of pediatric and preventive dentistry
Mangalore
KARNATAKA
575017
India |
| Phone |
9446628911 |
| Fax |
|
| Email |
98sandramariaenchackal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry
Yenepoya Dental College
Deralakatte,Manglore
575017 |
|
|
Primary Sponsor
|
| Name |
Dr Sandra maria Enchackal |
| Address |
Enchackal(H),Thodupuzha East p.o
Vadakkummury,major Sandeep road,
PRA 47,IDUKKI,KERALA
PIN: 685585 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Sandra Maria Enchackal |
Yenepoya Dental College,Mangalore |
Department of pediatric and preventive dentistry
Dakshina Kannada
KARNATAKA |
9446628911
98sandramariaenchackal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
6to 12 years children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. 6-12 year-old children requiring extraction of primary physiologic mobile tooth (grade III mobile)
2. Co-operative children with Frankl behaviour scale of 3/4
3. Participants with informed consent of parents or assent (in older children) |
|
| ExclusionCriteria |
| Details |
Children with special needs and systemic diseases or bleeding disorder
2. Children with known allergic reactions to topical anesthesia
3. Children who had analgesics for a minimum of 24hrs prior to the treatment |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of photobiomodulation therapy in extraction of primary grade III physiologic mobile teeth |
2-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of photobiomodulation therapy and 2% lignocaine gel in extraction of primary grade III physiologic mobile teeth |
2-4 weeks |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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 in dental care, stemming from potential tissue harm, is a major concern, especially in pediatric dentistry where it can significantly impact treatment success. The fear of dental pain often leads to delayed treatments, adversely affecting oral health. Topical anesthesia, is commonly used for extracting mobile teeth in pediatric dentistry, has drawbacks such as disagreeable taste, child discomfort, and potential adverse reactions, prompting the search for alternative pain management methods. Photobiomodulation therapy (PBMT) has emerged as a promising solution, offering a non-invasive, non-destructive, and non-thermal approach. PBMT’s anti-inflammatory and analgesic properties, along with its ability to impede nerve impulse conduction, make it integral in dentistry. Near-infrared lasers, falling within the "optimal window," allow effective penetration, highlighting PBMT as a valuable tool for reducing pain and improving therapeutic interventions in dental procedures, especially for pediatric patients undergoing tooth extractions. The aim of this study is to evaluate the effectiveness of photobiomodulation for the extraction of primary mobile teeth, assessing factors such as pain reduction, patient comfort, and overall procedural outcomes. Participants who need the extraction of primary mobile teeth in the age group of 6 to 12 years will be recruited for the study. It will be a bilateral split mouth study. The study will be conducted to evaluate the efficacy of photobiomodulationand topical anesthesia for extraction of primary physiologic mobile teeth as photobiomodulation can induce analgesic effect by stimulating cellular activity through exposure to low level light. |