| CTRI Number |
CTRI/2024/12/078494 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Low level laser therapy and its effect on gcf biomarkers and pain after orthodontic treatment |
|
Scientific Title of Study
|
To compare the impact of Low-Level Laser Therapy on Gingival Crevicular Fluid Alkaline Phosphatase and Aspartate Aminotransferase following placement of Elastomeric and Kesling separators with pain perception in an adult population: A Split-Mouth Randomized Control Trial 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 Sejul Jaiswal |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Second floor,201,Department of Orthodontics and Dentofacial Orthopaedics,Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8087252177 |
| Fax |
|
| Email |
thesej888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varunjeet Chaudhary |
| Designation |
Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Second Floor, 201, Department of Orthodontics and Dentofacial Orthopaedics, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7000037701 |
| Fax |
|
| Email |
drvarunjeetchaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sejul Jaiswal |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur |
| Address |
Second floor, 201, Department of Orthodontics and Dentofacial Orthopaedics, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8087252177 |
| Fax |
|
| Email |
thesej888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur - 441110, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Sejul Jaiswal |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur |
| 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 Sejul Jaiswal |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Second
Floor,201,Swargiya
Dadasaheb Kalmegh
Smruti Dental College
and Hospital , Hingna,
Nagpur
Nagpur
MAHARASHTRA |
8087252177
thesej888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alkaline Phosphatase |
Studies suggest that increased GCF ALP levels correlate with the degree of orthodontic tooth movement and may also relate to pain perception. As teeth are moved, the remodeling process and associated cellular activity can cause discomfort. Monitoring GCF ALP levels can provide insights into the biological response to orthodontic forces and help manage and understand the pain experienced by patients during treatment. |
| Comparator Agent |
Aspartate Aminotransferase |
Studies have shown that increased GCF AST levels are associated with the initial stages of orthodontic treatment, where patients typically experience the most discomfort. The enzymes presence reflects the inflammatory response and cellular turnover in the periodontal ligament as it adapts to the applied forces. Monitoring GCF AST levels can help in assessing the extent of tissue response and inflammation, thereby providing a better understanding of pain perception and helping to manage discomfort during orthodontic treatment. |
| Comparator Agent |
Elastomeric Separators |
Elastomeric separators are small rubber or plastic rings used in orthodontics to create space between teeth before fitting orthodontic bands or appliances. They are typically placed for 7 days or so in advance and may cause slight discomfort. Patients should avoid sticky foods and maintain gentle oral hygiene around the separators. |
| Comparator Agent |
Kesling Separators |
Kesling separators are small, metallic devices used in orthodontics to create space between teeth. They are typically wedge-shaped and can be easily placed and removed without causing much discomfort to the patient.They are also placed for 7 days |
| Intervention |
Low Level Laser Therapy |
Low-Level Laser Therapy (LLLT) is used in orthodontics for pain management by reducing inflammation and promoting tissue healing. it will be administered for 20 seconds. It involves the application of low-intensity laser light to the affected area, which helps in alleviating pain caused by orthodontic treatments such as braces adjustments. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 18-27 years.
2.Systemically healthy patients.
3.Patients with healthy periodontium with generalized probing depth of 3 mm and no radiographic bone loss.
4.Bilaterally symmetric arch (Presence of teeth on both sides of the arch)
|
|
| ExclusionCriteria |
| Details |
1. Patients on NSAIDs or opioids within a month before the study.
2. Patients on antibiotics during last 6 months
3. Removal or loss of the separator during the experiment.
4. Patients with poor oral hygienes and periodontal diseases.
5. Patients with systemic illnesses, oral lesions or pathologies.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association of the effect of Low-Level Laser Therapy on GCF biomarkers after placement of Kesling and Elastomeric separators along with pain perception. |
The study will be conducted in 4 visits and the level of Gingival Crevicular Fluid markers will be assessed at baseline, 24 hours, 48 hours and 72 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the association of the effect of Low-Level Laser Therapy on GCF biomarkers after placement of Kesling & Elastomeric separators along with pain perception. |
The study will be conducted in 4 visits.
First visit
Each patient’s oral cavity will be divided in four quadrants.
Will be assesed at baseline, 24 hours, 48 hours & 72 hours |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
30/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction - Posterior teeth endure higher masticatory forces than anterior teeth, making bands preferable to bonding in the posterior region. The average periodontal ligament (PDL) spacing is 0.25 mm. A 0.16 mm thick metal band without sufficient tooth separation can cause alveolar bone contraction, PDL hyalinization, and discomfort. Proper separation minimizes discomfort, protects tooth structure and soft tissue, and reduces patient strain. Effective separators should be radiopaque, easy to clean and install, and secure. Elastomeric separators, which are small and elastic, create space between adjacent teeth by placing rings of various thicknesses around the interproximal contact point. They come in two types: rounded and angular, and the separation process takes about seven days using pliers. Patients find elastic ring separators most comfortable. Kesling metallic ring separator springs, made from 0.016-inch Australian wire, consist of gingival, occlusal, and retentive arms, and a coil/helix. They create space for bands in about two days and come in four sizes based on arm length. Kesling separators are patient-friendly and faster than other types. Studies show discomfort peaks 24 hours after placement. Periodontal pain arises from pressure, ischemia, inflammation, and edema. Gingival crevicular fluid (GCF) is useful for identifying biomarkers, containing materials from oral bacteria, periodontium cells, host inflammatory cells, and serum. It is a non-invasive method for studying periodontal tissue issues. Low-Level Laser Therapy (LLLT), or photobiomodulation, reduces pain, chemical mediators, cytokines, and inflammation while promoting early wound healing. A randomized controlled trial aims to provide evidence on LLLT’s effectiveness in reducing inflammation and pain from separator placement, guiding its use as a non-invasive, cost-effective method for managing orthodontic pain. Objective - To evaluate the effect on GCF biomarkers with and without the use of Low-Level Laser Therapy after placement of Kesling and elastomeric separators. Methodology - This study will include 10 patients aged 18-27 requiring orthodontic treatment with separators. - Each patient will have a study and control site (left and right quadrants) for low-level laser therapy. - Informed consent will be obtained, with a thorough explanation and the option to drop out. - GCF samples will be collected before separator placement to find baseline biomarker values. - Kesling separators will be placed on the mesial and distal sides of the 1st molar in the maxillary arch, and elastomeric separators in the mandibular arch. - Low-level laser therapy will be applied to the test side, while the control side remains untreated. - The diode laser (GaAlAs) will operate at 810 nm, with 2 J/cm² energy density, and 200 mW power output for 20 seconds. - GCF will be collected from both sides at four time points: before separator placement, and 24, 48, and 72 hours after placement. - GCF samples will be collected from the mesial side of all four 1st molars, buccally and palatally, using a micropipette. - Samples will be transported in an airtight sterile container on ice to the biochemistry lab. - GCF will be biochemically assessed for Alkaline Phosphatase and AST. Evaluation - The study will be conducted over 4 visits. First Visit: - Divide each patient’s oral cavity into four quadrants. - Place Kesling separators on the upper arch and elastomeric separators on the lower arch. - Administer LLLT to one side of the oral cavity. - Collect GCF samples from all four quadrants. Subsequent Visits: - Repeat the same procedure at each visit. |