| CTRI Number |
CTRI/2025/02/079934 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring the Effects of Melatonin on Orthodontic Mini-Implant Stability: A Clinical Study |
|
Scientific Title of Study
|
Assessing the Effect of Exogenous Melatonin on The Stability of Orthodontic Mini-Implants: A Randomized Controlled Clinical 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 |
Sanjai J |
| Designation |
postgraduate student (MDS) |
| Affiliation |
Sri Venkaterwara Dental College and Hospital |
| Address |
room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri Venkateswara Dental College and Hospital, off Old Mahabalipuram Road,thalambur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
601204
India |
| Phone |
9445533302 |
| Fax |
|
| Email |
sjsanesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Umarevathi gopalakrishnan |
| Designation |
Professor |
| Affiliation |
Sri Venkaterwara Dental College and Hospital |
| Address |
room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri Venkateswara Dental College and Hospital, off Old Mahabalipuram Road,thalambur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9841289794 |
| Fax |
|
| Email |
umarevathigopalakrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Umarevathi gopalakrishnan |
| Designation |
Professor |
| Affiliation |
Sri Venkaterwara Dental College and Hospital |
| Address |
room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri Venkateswara Dental College and Hospital, off Old Mahabalipuram Road,thalambur, Chennai, Tamil Nadu 600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9841289794 |
| Fax |
|
| Email |
umarevathigopalakrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkaterwara Dental College and Hospital,
off, old mahabalipuram road,thalambur, chennai, tamilnadu 600130 |
|
|
Primary Sponsor
|
| Name |
Sanjai J |
| Address |
Sri Venkaterwara Dental College and Hospital,
off, old mahabalipuram road,thalambur, chennai, tamilnadu 600130 |
| 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 Sanjai J |
Sri Venkaterwara Dental College and Hospital |
room no 6,
department of orthodontics and dentofacial orthopedics,
Sri Venkaterwara Dental College and Hospital,
off old mahabalipuram road,thalambur, chennai, tamilnadu 600130
Kancheepuram
TAMIL NADU |
9445533302
sjsanesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri venkateswara dental college - member secretary ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients undergoing Orthodontic
treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo administration over the implants |
mini implants placed between the first and second premolar |
| Intervention |
Topical melatonin administration over the implants |
mini implants placed between the first and second premolar |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring orthodontic treatment involving the placement of mini implants for anchorage support.
Patients with average growth patterns, class I bimaxillary cases with upper first premolar extraction, and space closure will be selected to standardize the cases.
Young adults aged 15-25 years old will be selected |
|
| ExclusionCriteria |
| Details |
Patients with known sleep cycle disturbances, metabolic bone disorders to melatonin will be excluded.
Pregnant or lactating individuals, as melatonin administration may affect pregnancy outcomes or breast milk composition.
Patients who have used melatonin supplements 3 months before the study
Patients with active ongoing orthodontic treatment with Poor oral hygiene will be excluded which will lead to implant failure.
Patients unable or unwilling to attend scheduled follow-up visits will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability will be evaluated using insertion torque and resonance frequency analysis as primary outcome |
insertion torque value measured at the time of insertion and Resonance Frequency Analysis (RFA) measurements will be taken
At the time of mini-implant placement(T1),
One month after mini-implant placement as (T2),
Two months after mini-implant placement (T3),
Three months after mini-implant placement (T4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The implant migration and pain perception will be evaluated as secondary outcome |
Implant migration data will be collected from the lateral cephalogram
T1 at the time of placement and T4 i.e. After 3 months.
Pain perception will be assessed at T1, T2, T3, T4. Using pain scale chart.
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/02/2025 |
| Date of Study Completion (India) |
15/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 [sjsanesh@gmail.com].
- For how long will this data be available start date provided 24-02-2024 and end date provided 28-02-2026?
Response (Others) - Begining 6 months and ending 24 months
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
AIM: The study aims to evaluate the effect of topical administration of melatonin on the stability of orthodontic mini-implants through a Randomized controlled clinical trial.
Research question: Does the topical administration of melatonin have any effect on the stability of orthodontic mini-implants?
Hypothesis: The topical administration of melatonin has a significant effect on the stability of orthodontic mini-implants. The topical administration of melatonin significantly reduces implant migration in orthodontic mini-implants. The topical administration of melatonin has a significant impact on reducing pain perception during treatment with orthodontic mini-implants.
Null Hypothesis: The topical administration of melatonin does not have a significant effect on the stability of orthodontic mini-implants. The topical administration of melatonin does not significantly reduce implant migration in orthodontic mini-implants. The topical administration of melatonin does not have a significant impact on reducing pain perception during treatment with orthodontic mini-implants. P: Patients with average growth patterns, class I bimaxillary cases with upper first premolar extraction. I: Topical melatonin application over the mini implant. C: Placebo application over the mini implant. O: Implant stability, Implant migration, and pain perception. S: The sample size is 20 Experimental Group: Topical melatonin administration + mini-implant Control Group: Placebo (matching appearance) + mini-implant
Based on the inclusion and exclusion criteria the Orthodontic patients requiring mini-implants for anchorage support will be selected in this study. The primary objective is to evaluate implant stability through insertion torque and resonance frequency analysis. The secondary outcomes include assessing implant migration and pain perception among participants. Throughout the treatment period, patients will undergo orthodontic procedures, including bracket placement and wire adjustments. TADs will be inserted and data collected at specific intervals. Data collected will be tabulated and statistically analyzed. This study holds a non-invasive adjunctive approach to optimize mini-implant stability and treatment outcomes. If proven effective, exogenous melatonin could become a valuable addition to the orthodontic armamentarium, by enhancing anchorage support.
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