Exploring the Effects of Melatonin on Orthodontic Mini-Implant Stability: A Clinical Study

Assessing the Effect of Exogenous Melatonin on The Stability of Orthodontic Mini-Implants: A Randomized Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/079934

Enrollment

Registered

2025-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Topical melatonin administration over the implants: mini implants placed between the first and second premolar Control Intervention1: Placebo administration over the implants: mini impl

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Implant stability will be evaluated using insertion torque and resonance frequency analysis as primary outcomeTimepoint: 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	—

Measure

Time frame

Implant stability will be evaluated using insertion torque and resonance frequency analysis as primary outcomeTimepoint: 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

Measure	Time frame
The implant migration and pain perception will be evaluated as secondary outcomeTimepoint: 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.	—

Countries

India

Contacts

Public ContactDR Umarevathi gopalakrishnan

Sri Venkaterwara Dental College and Hospital

umarevathigopalakrishnan@gmail.com9841289794

Outcome results