| CTRI Number |
CTRI/2024/11/076557 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of two Laser energies used simultaneously in inhibiting pain and enhancing extraction wound healing in 6 to 25 year old individuals |
|
Scientific Title of Study
|
Effectiveness of Laser photobiomodulation using confluence of two wavelength photons in inhibiting pain and enhancing extraction wound healing compared to sham Laser in 6 to 25 year old individuals: A double blind randomized controlled 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 |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD, Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
SMBT Dental College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD, Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
SMBT Dental College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD, Department of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
SMBT Dental College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Dental Sciences, Krishna Vishwa Vidyapeeth, Deemed To Be University, Malkapur, Karad, District Satara, Maharashtra, India. PIN - 415539. |
|
|
Primary Sponsor
|
| Name |
School of Dental Sciences |
| Address |
School of Dental Sciences, Krishna Vishwa Vidyapeeth, Deemed To Be University, Malkapur, Karad, District Satara, Maharashtra, India. PIN - 415539 |
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SMBT Dental College and Hospital |
SMBT Dental College and Hospital, Ghulewadi, Sangamner, Maharashtra PIN-422608 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashikiran ND |
School of Dental Sciences |
Department of Pediatric and Preventive Dentistry
Satara
MAHARASHTRA |
9630070092
deansds@kvv.edu.in |
| Dr Vinaya Kumar Kulkarni |
SMBT Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, 102
Ahmadnagar
MAHARASHTRA |
8830483436
vinayakumar53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College, Sangamner |
Approved |
| Institutional Ethics Committee Krishna Vishwa Vidyapeeth Karad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser photobiomodulation using confluence of two wavelength photons (640nm and 810nm). |
Before administration of local anesthesia at the site of injection (Entry point of the needle), application of Laser PBM (100mW of 640nm + 100mW of 810nm) using continuous wave in contact mode for 60 seconds (The energy delivered will be 12J) applied only once on the oral mucosal surface. And
After extraction of tooth, application of Laser PBM (100mW of 640nm + 100mW of 810nm) using continuous wave in non-contact mode for 60 seconds (The energy delivered per point will be 12J) applied only once at 3 to 4 points on the extraction wound and surrounding oral mucosal surface. |
| Comparator Agent |
Sham Laser |
Before administration of local anesthesia at the site of injection (Entry point of the needle), application of Sham Laser (No energy is Delivered) in contact mode for 60 seconds applied only once on the oral mucosal surface. And
After extraction of tooth, application of Sham Laser (No energy is Delivered) in non-contact mode for 60 seconds only once at 3 to 4 points on the extraction wound and surrounding oral mucosal surface. |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children in the age group of 6-12 year, adolescents in 12-18 years and young adults in the age range of 18-25 years.
2. Children exhibiting cooperative behaviour (Frankl behavior rating 3 and 4)
3. Children requiring bilateral extraction of mandibular primary molars, adolescents requiring bilateral extraction of mandibular premolars for therapeutic purposes and adults requiring bilateral extraction of mandibular third molar teeth.
4. Participants/parents willing to provide the consent.
5. Children and adolescents willing to provide the assent. |
|
| ExclusionCriteria |
| Details |
1. Medically compromised individuals
2. Specially abled person
3. Individuals with known allergy to LA (Lignocaine Hydrochloride)
4. Individuals with Bleeding and Clotting Disorders
5. Individuals already under any medications which may alter the pain perception or wound healing
6. Individuals with craniofacial anomalies
7. Individuals with any oropharyngeal soft tissue lesions
8. Children with exfoliating teeth showing grade-3 mobility
|
|
|
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 Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laser photobiomodulation using confluence of 640nm and 810nm wavelength photons is expected to be effective in inhibiting post operative pain and enhancing the extraction wound healing in 6 to 25 year old individuals. |
At baseline, 3 days, 7 days and 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laser photobiomodulation using confluence of 640nm & 810nm wavelength photons is expected to be effective in inhibiting pain of injection during inferior alveolar nerve block anesthesia in 6 to 25 year old individuals. |
At baseline, during administration of inferior alveolar nerve block anesthesia. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinayakumar53@gmail.com].
- For how long will this data be available start date provided 24-10-2027 and end date provided 24-10-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Local anesthesia is pivotal in inhibiting pain during dental procedures, yet the pain induced by needle insertion often leads to non-compliance in the children, apprehension in the adolescents and young adults. Traditional approaches like topical local anesthetics, cryo-anesthesia, and acupressure may not adequately alleviate pain or promote optimal wound healing, necessitating the exploration of alternative strategies. Laser photobiomodulation (PBM) therapy is non-invasive and effective in enhancing the tissue regeneration and wound healing. It also decreases the pain and edema through anti-inflammatory effect. Harnessing the therapeutic potential of confluent use of red and near infrared spectrum laser PBM is least researched. Hence, this study is designed to evaluate the effectiveness of laser PBM using confluence of 640nm and 810nm wavelength photons in inhibiting pain and enhancing extraction wound healing in 6 to 25 year old individuals. It is a split mouth double blind randomized controlled trial. Thirty participants each, in the age groups of 6-12 years, 12-18 years and 18-25 years fulfilling the inclusion and exclusion criteria will be enrolled in to the study after parental consent and participant’s consent/assent. The allocation of the side and test or control sub-group will be done with lottery method, followed by allocation concealment for blinding purpose. The test side will receive confluent laser PMB of 640nm and 810nm (100mW 640nm + 100mW of 810nm) using continuous wave in contact mode for 60 seconds (The energy delivered will be 12J) at the injection site before inferior alveolar nerve block (IANB) anesthesia and the control side will receive sham laser. Similarly, the test side will receive confluent laser PBM after extraction of mandibular tooth at 3 to 4 points with same Laser parameters in non-contact mode and the control side will receive sham laser after tooth extraction. The pain of injection will be evaluated by Wong-Baker faces pain rating scale and Face, Legs, Activity, Cry, Consolability (FLACC) scale. The pulse rate will be evaluated before during and after the IANB anesthesia as biological indicator. The postoperative pain will be evaluated by Wong-Baker faces pain rating scale and healing of extraction wound by Healing index of Landry, Turnbull and Howley in the follow-up visits at 3, 7 and 15 days. The data will be complied and analyzed using appropriate statistical tests. The confluent laser PBM is expected to be effective in pain control and enhancing extraction wound healing. |