| CTRI Number |
CTRI/2023/04/051479 [Registered on: 11/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reversal of numbness after dental treatment using laser |
|
Scientific Title of Study
|
Effect of Diode Laser Photobiostimulation on Reversal of Oral Soft Tissue Local Anesthesia in Pediatric Patients – A Split-mouth Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MOHAMED ZIA UL HAQUE |
| Designation |
PG STUDENT- MDS PEDODONTICS AND PREVENTIVE DENTISTRY |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,
VISHNU DENTAL COLLEGE,
VISHNUPUR,
BHIMAVARAM.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9989398980 |
| Fax |
|
| Email |
dr.ziaulhaque@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AHALYA P |
| Designation |
READER |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,
VISHNU DENTAL COLLEGE,
VISHNUPUR,
BHIMAVARAM.
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,
VISHNU DENTAL COLLEGE,
VISHNUPUR,
BHIMAVARAM.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahaarticles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHAMED ZIA UL HAQUE |
| Designation |
PG STUDENT- MDS PEDODONTICS AND PREVENTIVE DENTISTRY |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,
VISHNU DENTAL COLLEGE,
VISHNUPUR,
BHIMAVARAM.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9989398980 |
| Fax |
|
| Email |
dr.ziaulhaque@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Vishnu Dental College |
| Address |
Vishnu Dental College, Bhimavaram |
| Type of Sponsor |
Other [private dental college] |
|
|
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 Zia ul Haque |
Vishnu Dental College |
NUMBER-5,
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,
West Godavari
ANDHRA PRADESH |
9989398980
haque.kik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VISHNU DENTAL COLLEGE, BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K045||Chronic apical periodontitis, (4) ICD-10 Condition: K046||Periapical abscess with sinus, (5) ICD-10 Condition: K047||Periapical abscess without sinus, (6) ICD-10 Condition: K001||Supernumerary teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser photoiostimulation |
810 nm diode laser photoiostimulation at 6 points with 0.2mW power for 20 seconds pre point |
| Comparator Agent |
placebo irradiation |
placebo irradiation |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with Frankel’s positive and definitely positive behavior are included.
2.Children aged 8 to 12 years with the ability to understand and respond to the sensation of soft tissue.
3. Patients who require infiltration anesthesia bilaterally in two different sessions (1ml to 1.5ml /session).
4. Non-allergic to local anesthesia and its components.
5. Patients who are not under any analgesic drugs at least 24 h before treatment
|
|
| ExclusionCriteria |
| Details |
1. Presence of any systemic conditions preventing dental treatment under local anesthesia.
2. Any errors in injection of anesthetic drug or insufficient anesthesia during treatment.
3. Failure of the child to appreciate the response to soft tissue anesthesia, during the training.
4. Children receiving more than one shot of local anesthetic drug.
5. Duration of treatment exceeding 30 minutes from time LA administration.
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of LA reversal
|
1 week intervel
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
heart rate
incidence of any adverse effects |
24 hours
1week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
22/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/01/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Local anesthesia (LA) is a major mode of pain control in pediatric dental practice, but it comes with the drawback of prolonged duration of action even after the completion of dental treatment procedure. This unwanted prolonged action of LA may cause lip and cheek bites in children. There are very few methods to reverse the LA effect, this present study is to explore the use of Laser photobiostimulation for this purpose. |