Introduction

Orthodontic treatment duration can lead to patient dissatisfaction and increased risks. Micro-osteoperforations (MOPs) and Low-Level Laser Therapy (LLLT) are techniques aimed at accelerating orthodontic tooth movement. MOPs are minimally invasive and stimulate bone remodeling through cortical perforations. LLLT, or photobiomodulation, is a non-invasive technique that enhances tissue healing and cellular activity. This study aims to evaluate whether combining LLLT with MOPs improves alignment rate and pain perception compared to MOPs alone. The purpose of this randomized controlled trial is to find out whether micro-osteoperforations along with low level laser therapy accelerates tooth movement or not as compared to micro-osteoperforations alone.

 

3.1 Primary Research Question

What is the difference in the rate of orthodontic alignment of mandibular anterior teeth when combining LLLT with mini-screw-assisted MOPs compared to MOPs alone?

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3.2 Secondary Research Question

What is the difference in pain perception during mandibular anterior alignment when LLLT is combined with MOPs compared to MOPs alone?

 

4.1 Primary Hypothesis

There is some difference in the rate of mandibular anterior alignment between patients receiving MOPs with LLLT and those receiving MOPs alone.

 

4.2 Null Hypothesis

There is no significant difference in the alignment rate between the two groups.

 

4.3 Alternative Hypothesis

There is a significant difference in the alignment rate between the two groups.

 

05) Review of Literature

Previous studies show that MOPs enhance tooth movement and reduce treatment time by stimulating the Regional Acceleratory Phenomenon (RAP). LLLT has also been shown to accelerate tooth movement, reduce inflammation, and promote bone remodeling. Multiple randomized controlled trials and systematic reviews confirm the effectiveness and safety of both MOPs and LLLT in orthodontics, though some variation exists in outcomes based on application parameters and individual patient responses.

 

6.1 Primary Objectives

To evaluate the difference in the rate of mandibular anterior alignment between MOPs with LLLT and MOPs alone.

 

6.2 Other Objectives

To assess the difference in pain perception during alignment between the two intervention groups.

 

7) Methodology

• Study Design: Prospective, parallel-arm randomized controlled clinical trial.
• Setting: Department of Orthodontics and Dentofacial Orthopaedics, affiliated with MUHS, Nashik.
• Population: Orthodontic patients with moderate mandibular anterior crowding.
• Sample Size: 40 participants (20 per group, stratified by gender).
• Inclusion Criteria: Age 18–35, extraction cases with 4–6 mm crowding, fully erupted mandibular anteriors, informed consent.
• Exclusion Criteria: Severe malocclusion, prior orthodontic treatment/surgery, periodontal disease, pregnancy, systemic conditions affecting bone metabolism, smokers, medication affecting bone healing.

 

Materials: Mini-screws (1.5mm x 8mm), low-level laser (980 nm GaAlAs diode), MBT brackets, orthodontic wires, bonding materials, digital caliper.

 

Procedure:
Participants are randomized into two groups:

• Group 1 (MOPs + LLLT): Micro-osteoperforations on Day 0 with follow-up LLLT on Days 7, 28, and 56.
• Group 2 (MOPs only): Micro-osteoperforations on Day 0 only.

Fixed appliances are bonded on Day 0. Alignment is initiated using 0.014-inch NiTi wire, replaced at each visit. Alginate impressions and cast models are made at T0, T1, T2, and T3. Pain is assessed via VAS at 12, 24, and 48 hours post-intervention.

 

Micro-Osteoperforation Protocol:
Performed under local anesthesia using mini-screws for perforations (8 total sites, 4 mm deep, 1.5 mm diameter), avoiding the midline to prevent frenum trauma.

LLLT Protocol:
Class IV laser (980 nm, 10 W, 25.7 J/cm²), applied labially using a whitening handpiece (2.8 cm² area) for 30 seconds per session.

 

Follow-Up:
Orthodontic assessments and wire changes occur at T1 (Day 28), T2 (Day 56), and T3 (Day 84). Pain assessments are electronically collected using VAS.

 

Outcome Measures

Primary Outcome: Degree of mandibular anterior alignment using Little’s Irregularity Index, measured on study casts at four time points.

Secondary Outcome: Pain perception measured using VAS at 12, 24, and 48 hours post-procedure.

 

Statistical Analysis

Data analyzed using SPSS v21.0 at 95% CI and 80% power. Normality tests (Shapiro-Wilk, Kolmogorov-Smirnov), variance tests (Levene’s), Repeated Measures ANOVA (with Bonferroni correction), and non-parametric equivalents (Friedman’s, Mann-Whitney U) will be applied as appropriate. Significance set at p < 0.05.