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

Phase 3

Completed

• Conditions: Healthy patients undergoing Orthodontictreatment

• Registration Number: CTRI/2025/02/079934
• Lead Sponsor: Sanjai J

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-01-02
• Study Completion: 2025-05-15
• Study Start: 2025-12-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
The implant migration and pain perception will be evaluated as secondary outcome	Implant migration data will be collected from the lateral cephalogram

Trial Locations

Locations (1)

Sri Venkaterwara Dental College and Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Sri Venkaterwara Dental College and Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Sanjai J

Principal investigator

9445533302

sjsanesh@gmail.com