Malocclusion of Anterior TeethLLLTNCT07286474
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
A study testing Cholecalciferol (Vit D3), Low-Level Laser Therapy and Fixed Orthodontic Appliance in people with Malocclusion of Anterior Teeth, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
Trial summary
This clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) in conjunction with oral vitamin D3 supplementation in accelerating orthodontic tooth movement in adults with crowded mandibular anterior teeth undergoing orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion of Anterior Teeth
- What is being tested?
- Cholecalciferol (Vit D3), Low-Level Laser Therapy and Fixed Orthodontic Appliance
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants requiring orthodontic treatment for crowding in the range of 4 to 8 mm in the lower anterior segment.
- Age range: 18 to 40 years.
- Angles Class I, II or III malocclusion
- Fully erupted permanent dentition
- Good oral and general health
- Normal range of Vitamin D levels
Who cannot join
- Deficiency of Vitamin D levels below normal range. • Medically compromised patients with thyroid, parathyroid, or renal and liver diseases.
- Patients on medication, especially corticosteroid and anticonvulsant drugs • Poor oral hygiene
- Pregnancy
- Lactation
- History of craniofacial abnormalities or syndromes that may affect orthodontic tooth movements.
- Participants failing to complete the Vitamin D supplementation log sheets will be excluded to ensure accurate data collection.
- Inability to comply with the study protocol or unable to complete the study due to personal, medical, or logistical reasons (e.g., missed follow-up visits or failure to undergo assessments) will be excluded to maintain data integrity and minimize biases from incomplete participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Combined Low-Level Laser Therapy (LLLT) and Oral Vitamin D3 Supplements on Orthodontic Tooth Movements: A Randomized Controlled Trial.
This clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) in conjunction with oral vitamin D3 supplementation in accelerating orthodontic tooth movement in adults with crowded mandibular anterior teeth undergoing orthodontic treatment. Additionally, the study seeks to assess the safety profile and potential adverse effects, including pain and root resorption.
The primary research questions are as follows:
Read more
- Does vitamin D3 enhance the rate of orthodontic tooth movement?
- Does the combination of vitamin D3 and LLLT result in a greater acceleration of tooth movement compared to either intervention alone?
- Do vitamin D3 and LLLT influence the extent of root resorption?
- Do vitamin D3 and LLLT mitigate pain associated with orthodontic treatment?
- Do vitamin D3 and LLLT reduce the frequency of required clinical visits?
The study will compare the outcomes of orthodontic treatment with braces alone, braces with vitamin D3 supplementation, and braces with both vitamin D3 and LLLT, to determine their effects on the rate of tooth movement, pain reduction, and root resorption.
Participants will undergo the following procedures:
- A blood test to assess baseline vitamin D levels.
- Placement of orthodontic braces.
- Daily administration of vitamin D3 supplements for those assigned to the relevant groups, commencing with a loading dose one week prior to the initiation of orthodontic treatment.
- Application of LLLT to the gingival tissues for participants in the corresponding group, administered at the start and during follow-up visits.
- Regular clinic visits every four weeks for monitoring, pain assessment, and measurement of tooth movement until the completion of orthodontic alignment.
Read the detailed description
Orthodontic treatment is instrumental in aligning teeth and enhancing both aesthetic and functional aspects of smiles and bites. However, the duration of such treatment is typically protracted, averaging between 1.5 to 3 years. This extended timeframe can result in complications such as discomfort, root resorption, plaque accumulation, periodontal issues, and enamel demineralization. Both patients undergoing orthodontic treatment and their orthodontists seek methods to expedite the process without compromising safety. Orthodontic tooth movement is facilitated by the application of gentle forces through Standard Orthodontic treatment , which induce remodeling of the surrounding bone. This process involves bone resorption on one side and new bone formation on the other, mediated by osteoclasts and osteoblasts, as well as the involvement of blood vessels and nerves within the periodontal tissues. Over time, various strategies have been explored to accelerate tooth movement. Surgical interventions, such as corticotomy or piezocision, have demonstrated efficacy in hastening the process but are invasive and may cause apprehension among patients. Non-surgical approaches, including vibrational devices, magnetic fields, or hormonal injections, have been investigated, though some present adverse effects or limited efficacy. Low-level laser therapy (LLLT) emerges as a non-invasive alternative, utilizing low-energy light to enhance healing processes. LLLT has been shown to augment blood circulation, reduce inflammation, and enhance the function of bone cells. Empirical evidence suggests that LLLT may accelerate orthodontic tooth movement by modulating proteins and cellular activities involved in bone remodeling, such as increasing RANKL expression, which facilitates bone resorption, and alleviating orthodontic pain.
Vitamin D3, commonly referred to as the "sunshine vitamin," is essential for maintaining bone health. It is synthesized in the body through skin exposure to sunlight or obtained from dietary sources such as fish, eggs, or supplements. Vitamin D3 plays a crucial role in regulating calcium and phosphorus levels, which are vital for strong bones. In the field of orthodontics, vitamin D3 may facilitate bone remodeling during tooth movement. Animal studies have indicated that local injections of vitamin D3 near teeth can enhance movement; however, human studies have yielded mixed results, with some demonstrating accelerated movement with local vitamin D3 application, while others do not. Oral supplementation is considered safer and more convenient, yet there is a paucity of research examining its effects on orthodontic treatment. To date, no studies have investigated the combined use of low-level laser therapy (LLLT) and oral vitamin D3. It is hypothesized that these interventions may have a synergistic effect: vitamin D3 enhances bone metabolism, while LLLT reduces inflammation and promotes healing. This study aims to address this gap by evaluating whether the combination of LLLT and oral vitamin D3 accelerates the alignment of crowded lower anterior teeth more effectively than either treatment alone, while also monitoring potential side effects such as pain or root resorption.
This study is a randomized controlled trial comprising three groups to facilitate an equitable comparison of treatments. The participants are adults aged 18 to 40 years, exhibiting moderate dental crowding (4-8 mm) in the mandibular anterior region, necessitating orthodontic intervention. Eligibility criteria include normal vitamin D levels, overall good health, and a complete set of permanent teeth. Exclusion criteria encompass individuals with deficient vitamin D levels, specific medical conditions (such as thyroid or renal disorders), pregnancy, or inadequate oral hygiene. The target sample size is approximately 39 participants, distributed equally among the groups: Group A will receive orthodontic Standard Orthodontic treatment in conjunction with daily vitamin D3 supplementation, beginning with a high dose followed by maintenance dosing; Group B will receive Standard Orthodontic treatment , vitamin D3 supplementation, and low-level laser therapy (LLLT); the Control Group will receive Standard Orthodontic treatment only. Randomization is conducted using software to mitigate bias. The study adheres to ethical standards and the CONSORT guidelines to ensure transparent reporting.Procedures Initially, all participants undergo blood tests to assess vitamin D levels. Individuals with deficient levels are referred for treatment and are excluded from participation. Eligible participants provide informed consent and undergo standard orthodontic documentation, including photographs, X-rays, and study models. The orthodontic treatment commences with the application of 0.022" MBT-type Standard Orthodontic treatment on both the upper and lower dentition. The orthodontic wires are incrementally thickened to facilitate dental alignment, beginning with 0.014" flexible nickel-titanium, followed by 0.016", 0.016x0.022", and ultimately 0.017x0.025" steel wires. For the vitamin D3 cohort, a 50,000 IU dose is administered one week prior to the initiation of orthodontic treatment, followed by a daily intake of 1,000 IU until dental alignment is achieved. In the Low-Level Laser Therapy (LLLT) group, a diode laser (940 nm, 2.5 W power) equipped with a whitening handpiece is employed. The laser light is applied directly to the gingival tissue above the lower anterior teeth for 30 seconds at the commencement of treatment, on day 14, day 30, and subsequently every four weeks. Protective eyewear is mandatory during these sessions. Progress evaluations occur at four-week intervals, utilizing Little's Irregularity Index on study models to quantify dental crowding by summing the interproximal contact point discrepancies of the lower anterior teeth. Treatment concludes when the index reaches 0 mm, indicating complete alignment. Root resorption is assessed through comparative pre- and post-treatment X-rays of the lower anterior teeth, graded on a scale from 0 (no change) to 4 (severe resorption). Pain levels are documented daily for seven days following each wire adjustment or laser session, using a 10-cm visual analog scale (0 indicating no pain, 10 indicating the most severe pain). Participants also record any analgesic consumption. Data analysis involves statistical tests to compare the groups regarding treatment duration, root resorption, and pain levels. The findings have the potential to inform the development of more efficient and less painful orthodontic treatment protocols.
- Conditions
- Malocclusion of Anterior Teeth
- Being tested
- Cholecalciferol (Vit D3), Low-Level Laser Therapy, Fixed Orthodontic Appliance
- Keywords
- LLLT, vitamin D3 supplements, randomized controlled trial, mandibular crowding, root resorption, pain perception, acceleration of orthodontics
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (Vit D3)Dietary supplement
Oral cholecalciferol supplementation: initial loading dose of 50,000 IU one week before orthodontic treatment initiation, followed by daily maintenance dose of 1,000 IU until alignment completion. Administered to participants with baseline sufficient Vitamin D levels.
Low-Level Laser TherapyRadiation
Diode laser (Biolase 10W 940±10nm, InGaAlAs) with tooth whitening handpiece (spot size 2.8 cm²), wavelength 940 nm, power output 2.5 W, energy density 25.7 J/cm², continuous wave mode. Applied labially in direct contact at mucogingival junction for 30 seconds. Initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion. Eye protection worn by operator and participant.
Fixed Orthodontic ApplianceDevice
Pre-adjusted edgewise conventional brackets with 0.022" MBT (McLaughlin Bennett Trevisi) prescription (3M Unitek), bondable 0.022" single slot molar tubes, bonded using Transbond XT light cure material on upper and lower arches. Wire sequencing: initial 0.014" super elastic nickel-titanium (SE-NiTi), followed by 0.016" SE-NiTi, 0.016 x 0.022" SE-NiTi, and finally 0.017 x 0.025" stainless steel wire until alignment completion. Adjustments every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 Only Group | Experimental | Participants receive standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). Additionally, oral Vitamin D3 supplementation: single loading dose of 50,000 IU one week before treatment, followed by 1,000 IU daily maintenance until alignment completion. No LLLT. Receives: Dietary Supplement: Cholecalciferol (Vit D3); Device: Fixed Orthodontic Appliance |
| Vitamin D3 + LLLT Group | Experimental | Participants receive standard orthodontic treatment as above. Plus oral Vitamin D3 supplementation (50,000 IU loading one week before, 1,000 IU daily). Plus LLLT using InGaAlAs diode laser (940 nm, 2.5 W, 25.7 J/cm², 30 seconds labially at muco-gingival junction) initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion. Receives: Dietary Supplement: Cholecalciferol (Vit D3); Radiation: Low-Level Laser Therapy |
| Control Group | Active comparator | Participants receive only standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). No Vitamin D3 supplementation or LLLT. Receives: Device: Fixed Orthodontic Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Orthodontic Tooth Movement
The rate of reduction in mandibular anterior crowding, measured in mm/month using Little's Irregularity Index (sum of linear displacements between contact points of the six mandibular anterior teeth from canine to canine, assessed via dental models). Compared across groups to evaluate acceleration effects.
Measured: From baseline (initiation of alignment) to complete alignment (Little's Irregularity Index reaches 0 mm), assessed every 4 weeks (estimated duration 6-10 months per participant)
Secondary outcomes (3)
Root Resorption
Degree of apical root resorption in mandibular anterior teeth, assessed using periapical radiographs and graded on a 0-4 scale (0 = no resorption, 4 = severe resorption >4 mm). Compared between baseline and post-alignment images.
Measured: Baseline and at completion of alignment (estimated 6-10 months)
Pain Perception
Orthodontic pain intensity measured using a 10-cm Visual Analogue Scale (VAS; 0 = no pain, 10 = worst pain imaginable). Participants record daily scores for 7 days following each archwire activation or LLLT session.
Measured: Daily for 7 days after each monthly visit, throughout the alignment phase (up to 10 months)
Duration of Orthodontic Alignment
Total time required to achieve complete resolution of mandibular anterior crowding (from initiation of fixed appliance treatment to Little's Irregularity Index of 0 mm).
Measured: From baseline to complete alignment, monitored every 4 weeks (estimated 6-10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion of Anterior TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The three study arms in this randomized controlled trial are as follows: * Group 1A (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (initial 50,000 IU dose one week before treatment, followed by 1,000 IU daily maintenance). * Group 1B (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (as above) combined with Low-Level Laser Therapy (LLLT) applied to the gums at specified intervals. * Control Group: Standard orthodontic treatment (braces) only, with no Vitamin D3 supplements or LLLT.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Abid Altaf Bukhari, Universiti Sains Malaysia
- Investigators
- Rozita Hassan, BDS, MS, MOrtho RCSEd, Study director, Universiti Sains Malayisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286474
- Sponsor's protocol ID
- USM/JEPeM/KK/24040356
- Acronym
- LLLT
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Low-Level Laser Therapy (LLLT) and Oral Vitamin D3 Supplements on Orthodontic Tooth Movements: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07286474
- Acronym / sponsor ID
- LLLT / USM/JEPeM/KK/24040356
- Conditions
- Malocclusion of Anterior Teeth
- Keywords
- LLLT, vitamin D3 supplements, randomized controlled trial, mandibular crowding, root resorption, pain perception, acceleration of orthodontics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) in conjunction with oral vitamin D3 supplementation in accelerating orthodontic tooth movement in adults with crowded mandibular anterior teeth undergoing orthodontic treatment. Additionally, the study seeks to assess the safety profile and potential adverse effects, including pain and root resorption.
The primary research questions are as follows:
- Does vitamin D3 enhance the rate of orthodontic tooth movement?
- Does the combination of vitamin D3 and LLLT result in a greater acceleration of tooth movement compared to either intervention alone?
- Do vitamin D3 and LLLT influence the extent of root resorption?
- Do vitamin D3 and LLLT mitigate pain associated with orthodontic treatment?
- Do vitamin D3 and LLLT reduce the frequency of required clinical visits?
The study will compare the outcomes of orthodontic treatment with braces alone, braces with vitamin D3 supplementation, and braces with both vitamin D3 and LLLT, to determine their effects on the rate of tooth movement, pain reduction, and root resorption.
Participants will undergo the following procedures:
- A blood test to assess baseline vitamin D levels.
- Placement of orthodontic braces.
- Daily administration of vitamin D3 supplements for those assigned to the relevant groups, commencing with a loading dose one week prior to the initiation of orthodontic treatment.
- Application of LLLT to the gingival tissues for participants in the corresponding group, administered at the start and during follow-up visits.
- Regular clinic visits every four weeks for monitoring, pain assessment, and measurement of tooth movement until the completion of orthodontic alignment.
Detailed description
Orthodontic treatment is instrumental in aligning teeth and enhancing both aesthetic and functional aspects of smiles and bites. However, the duration of such treatment is typically protracted, averaging between 1.5 to 3 years. This extended timeframe can result in complications such as discomfort, root resorption, plaque accumulation, periodontal issues, and enamel demineralization. Both patients undergoing orthodontic treatment and their orthodontists seek methods to expedite the process without compromising safety. Orthodontic tooth movement is facilitated by the application of gentle forces through Standard Orthodontic treatment , which induce remodeling of the surrounding bone. This process involves bone resorption on one side and new bone formation on the other, mediated by osteoclasts and osteoblasts, as well as the involvement of blood vessels and nerves within the periodontal tissues. Over time, various strategies have been explored to accelerate tooth movement. Surgical interventions, such as corticotomy or piezocision, have demonstrated efficacy in hastening the process but are invasive and may cause apprehension among patients. Non-surgical approaches, including vibrational devices, magnetic fields, or hormonal injections, have been investigated, though some present adverse effects or limited efficacy. Low-level laser therapy (LLLT) emerges as a non-invasive alternative, utilizing low-energy light to enhance healing processes. LLLT has been shown to augment blood circulation, reduce inflammation, and enhance the function of bone cells. Empirical evidence suggests that LLLT may accelerate orthodontic tooth movement by modulating proteins and cellular activities involved in bone remodeling, such as increasing RANKL expression, which facilitates bone resorption, and alleviating orthodontic pain.
Vitamin D3, commonly referred to as the "sunshine vitamin," is essential for maintaining bone health. It is synthesized in the body through skin exposure to sunlight or obtained from dietary sources such as fish, eggs, or supplements. Vitamin D3 plays a crucial role in regulating calcium and phosphorus levels, which are vital for strong bones. In the field of orthodontics, vitamin D3 may facilitate bone remodeling during tooth movement. Animal studies have indicated that local injections of vitamin D3 near teeth can enhance movement; however, human studies have yielded mixed results, with some demonstrating accelerated movement with local vitamin D3 application, while others do not. Oral supplementation is considered safer and more convenient, yet there is a paucity of research examining its effects on orthodontic treatment. To date, no studies have investigated the combined use of low-level laser therapy (LLLT) and oral vitamin D3. It is hypothesized that these interventions may have a synergistic effect: vitamin D3 enhances bone metabolism, while LLLT reduces inflammation and promotes healing. This study aims to address this gap by evaluating whether the combination of LLLT and oral vitamin D3 accelerates the alignment of crowded lower anterior teeth more effectively than either treatment alone, while also monitoring potential side effects such as pain or root resorption.
This study is a randomized controlled trial comprising three groups to facilitate an equitable comparison of treatments. The participants are adults aged 18 to 40 years, exhibiting moderate dental crowding (4-8 mm) in the mandibular anterior region, necessitating orthodontic intervention. Eligibility criteria include normal vitamin D levels, overall good health, and a complete set of permanent teeth. Exclusion criteria encompass individuals with deficient vitamin D levels, specific medical conditions (such as thyroid or renal disorders), pregnancy, or inadequate oral hygiene. The target sample size is approximately 39 participants, distributed equally among the groups: Group A will receive orthodontic Standard Orthodontic treatment in conjunction with daily vitamin D3 supplementation, beginning with a high dose followed by maintenance dosing; Group B will receive Standard Orthodontic treatment , vitamin D3 supplementation, and low-level laser therapy (LLLT); the Control Group will receive Standard Orthodontic treatment only. Randomization is conducted using software to mitigate bias. The study adheres to ethical standards and the CONSORT guidelines to ensure transparent reporting.Procedures Initially, all participants undergo blood tests to assess vitamin D levels. Individuals with deficient levels are referred for treatment and are excluded from participation. Eligible participants provide informed consent and undergo standard orthodontic documentation, including photographs, X-rays, and study models. The orthodontic treatment commences with the application of 0.022" MBT-type Standard Orthodontic treatment on both the upper and lower dentition. The orthodontic wires are incrementally thickened to facilitate dental alignment, beginning with 0.014" flexible nickel-titanium, followed by 0.016", 0.016x0.022", and ultimately 0.017x0.025" steel wires. For the vitamin D3 cohort, a 50,000 IU dose is administered one week prior to the initiation of orthodontic treatment, followed by a daily intake of 1,000 IU until dental alignment is achieved. In the Low-Level Laser Therapy (LLLT) group, a diode laser (940 nm, 2.5 W power) equipped with a whitening handpiece is employed. The laser light is applied directly to the gingival tissue above the lower anterior teeth for 30 seconds at the commencement of treatment, on day 14, day 30, and subsequently every four weeks. Protective eyewear is mandatory during these sessions. Progress evaluations occur at four-week intervals, utilizing Little's Irregularity Index on study models to quantify dental crowding by summing the interproximal contact point discrepancies of the lower anterior teeth. Treatment concludes when the index reaches 0 mm, indicating complete alignment. Root resorption is assessed through comparative pre- and post-treatment X-rays of the lower anterior teeth, graded on a scale from 0 (no change) to 4 (severe resorption). Pain levels are documented daily for seven days following each wire adjustment or laser session, using a 10-cm visual analog scale (0 indicating no pain, 10 indicating the most severe pain). Participants also record any analgesic consumption. Data analysis involves statistical tests to compare the groups regarding treatment duration, root resorption, and pain levels. The findings have the potential to inform the development of more efficient and less painful orthodontic treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The three study arms in this randomized controlled trial are as follows: * Group 1A (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (initial 50,000 IU dose one week before treatment, followed by 1,000 IU daily maintenance). * Group 1B (Experimental): Standard orthodontic treatment (braces) plus oral Vitamin D3 supplements (as above) combined with Low-Level Laser Therapy (LLLT) applied to the gums at specified intervals. * Control Group: Standard orthodontic treatment (braces) only, with no Vitamin D3 supplements or LLLT.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 Only Group | Experimental | Dietary Supplement: Cholecalciferol (Vit D3), Device: Fixed Orthodontic ApplianceParticipants receive standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). Additionally, oral Vitamin D3 supplementation: single loading dose of 50,000 IU one week before treatment, followed by 1,000 IU daily maintenance until alignment completion. No LLLT. |
| Vitamin D3 + LLLT Group | Experimental | Dietary Supplement: Cholecalciferol (Vit D3), Radiation: Low-Level Laser TherapyParticipants receive standard orthodontic treatment as above. Plus oral Vitamin D3 supplementation (50,000 IU loading one week before, 1,000 IU daily). Plus LLLT using InGaAlAs diode laser (940 nm, 2.5 W, 25.7 J/cm², 30 seconds labially at muco-gingival junction) initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion. |
| Control Group | Active comparator | Device: Fixed Orthodontic ApplianceParticipants receive only standard orthodontic treatment with pre-adjusted edgewise brackets (0.022" MBT prescription) and wire sequencing (0.014" NiTi initial, progressing to 0.017x0.025" SS). No Vitamin D3 supplementation or LLLT. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants requiring orthodontic treatment for crowding in the range of 4 to 8 mm in the lower anterior segment.
- Age range: 18 to 40 years.
- Angles Class I, II or III malocclusion
- Fully erupted permanent dentition
- Good oral and general health
Key exclusion criteria (7 listed)
- Deficiency of Vitamin D levels below normal range. • Medically compromised patients with thyroid, parathyroid, or renal and liver diseases.
- Patients on medication, especially corticosteroid and anticonvulsant drugs • Poor oral hygiene
- Pregnancy
- Lactation
- History of craniofacial abnormalities or syndromes that may affect orthodontic tooth movements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol (Vit D3)Oral cholecalciferol supplementation: initial loading dose of 50,000 IU one week before orthodontic treatment initiation, followed by daily maintenance dose of 1,000 IU until alignment completion. Administered to participants with baseline sufficient Vitamin D levels. | Dietary supplement | Vitamin D3 + LLLT Group, Vitamin D3 Only Group |
| Low-Level Laser TherapyDiode laser (Biolase 10W 940±10nm, InGaAlAs) with tooth whitening handpiece (spot size 2.8 cm²), wavelength 940 nm, power output 2.5 W, energy density 25.7 J/cm², continuous wave mode. Applied labially in direct contact at mucogingival junction for 30 seconds. Initiated at alignment start, repeated on days 14 and 30, then every 4 weeks until completion. Eye protection worn by operator and participant. | Radiation | Vitamin D3 + LLLT Group |
| Fixed Orthodontic AppliancePre-adjusted edgewise conventional brackets with 0.022" MBT (McLaughlin Bennett Trevisi) prescription (3M Unitek), bondable 0.022" single slot molar tubes, bonded using Transbond XT light cure material on upper and lower arches. Wire sequencing: initial 0.014" super elastic nickel-titanium (SE-NiTi), followed by 0.016" SE-NiTi, 0.016 x 0.022" SE-NiTi, and finally 0.017 x 0.025" stainless steel wire until alignment completion. Adjustments every 4 weeks. | Device | Control Group, Vitamin D3 Only Group |
Primary outcome
Rate of Orthodontic Tooth Movement
Time frame: From baseline (initiation of alignment) to complete alignment (Little's Irregularity Index reaches 0 mm), assessed every 4 weeks (estimated duration 6-10 months per participant)
The rate of reduction in mandibular anterior crowding, measured in mm/month using Little's Irregularity Index (sum of linear displacements between contact points of the six mandibular anterior teeth from canine to canine, assessed via dental models). Compared across groups to evaluate acceleration effects.
3 secondary outcomes
Root Resorption
Time frame: Baseline and at completion of alignment (estimated 6-10 months)
Pain Perception
Time frame: Daily for 7 days after each monthly visit, throughout the alignment phase (up to 10 months)
Duration of Orthodontic Alignment
Time frame: From baseline to complete alignment, monitored every 4 weeks (estimated 6-10 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Malocclusion of Anterior Teeth
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozita Hassan, BDS, MS, MOrtho RCSEd study director
Universiti Sains Malayisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (Vit D3), Low-Level Laser Therapy and Fixed Orthodontic Appliance in people with Malocclusion of Anterior Teeth, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Orthodontic Tooth Movement (time frame: From baseline (initiation of alignment) to complete alignment (Little's Irregularity Index reaches 0 mm), assessed every 4 weeks (estimated duration 6-10 months per participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.