Angle Class INCT05202496
Effect of Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
A study testing Calcitriol 0.25Mcg Cap and orthodontic treatment in people with Angle Class I, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study is to evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups with a sample size of 24 and having serum vitamin D level (30-40 ng/ml). Read more about this study
- Who is it for?
- Ages 19 to 25 years
- Conditions the study is for
- Angle Class I
- What is being tested?
- Calcitriol 0.25Mcg Cap and orthodontic treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 20 Nov 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient in the age group of 19-25 years .
- Good general health status.
- Healthy periodontium
- Absence of root resorption.
- Absence of any chronic disorders
- No history of orthodontic treatment.
Who cannot join
- Presence of any signs and symptoms of gingival and periodontal diseases.
- Any Systemic/Bone/metabolic/hormonal disease illness known to affect the outcome of orthodontic therapy or requiring administration of vitamin D
- Any kind of prolonged drug administration (chronic drug intake)
- Pregnant or lactating women.
- Smoking habit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
This study is to evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups with a sample size of 24 and having serum vitamin D level (30-40 ng/ml). All subjects undergo orthodontic levelling and alignment after premolar extractions followed by vitamin D supplementation in the experimental group. The rate of canine retraction will be measured in both the groups and CBCT taken in the interval of 6 months before and after intervention to measure root changes
Read the detailed description
Aims and Objectives: To evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups. Secondary objective: To compare root resorption in experimental and control group. Setting: Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.
Study Design: Prospective, double blind, randomized clinical study Time frame: Duration of study is one year Population/participant: Inclusion criteria:- Patients with age between 19-25 years with malocclusion requiring bilateral extraction of maxillary 1st premolars in good general health and healthy periodontium.
Exclusion Criteria:- Presence of any systemic/bone/metabolic/hormonal diseases, long-term drug history, pregnant or lactating women, smoking habit, root resorption orany chronic disorders Sample size: A sample size of 10 per group for the present study was calculated to detect a clinical difference of 0.89 with a pooled standard deviation of 0.53 (effect size 1.67) at 95% power and alpha significance level at 0.05.
To compensate for 20% dropouts the final sample size was calculated to be 11 per group (i.e) total sample size will be 24.
Method of study: Patients who fulfill the selection criteria will be selected for the study. After taking the pretreatment records and recording the pretreatment vitamin D levels the patients will be sent for extraction of 1st premolars. Treatment will be initiated by bonding 0.022"slot MBT straight wire appliance. Retraction will be done on 0.019"x 0.025" SS wires using closed coil NiTi springs. Patients of study group will be instructed to take adequate dose of vitamin D3 during phase of space closure. Serum vitamin D levels will be checked at 4th,8th, 12th and 16th weeks and rate of canine retraction will be measured at these time intervals. Root resorption will be measured from CBCT at the end of 6 months Outcome Measures: The outcome variables will be the rate of retraction measured in millimeters. Changes in root length will be measured and compared between the two groups Statistical Analysis: Data will be checked for normality. If it is in normal distribution, intra group comparison will be done by student's t-test between two time points and inter group comparison will be done by using Independent T test between two groups. If it is in non-normal distribution, intra group comparison will be done by Wilcoxon signed rank test and inter group comparison will be done by Mann-Whitney U test.
- Conditions
- Angle Class I
- Being tested
- Calcitriol 0.25Mcg Cap, orthodontic treatment
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitriol 0.25Mcg CapDrug
Also called Rocaltrol
After orthodontic levelling and alignment, experimental group subjects are administered one capsule of calcitriol 0.25 mcg on a daily basis during the study period. Also, serum vitamin D levels are monitored at monthly intervals and rate of canine retraction is measured at monthly intervals
orthodontic treatmentProcedure or surgery
experimental group subjects undergo orthodontic treatment after extraction of premolars
| Study group | Role | What they receive |
|---|---|---|
| Experimental: oral vitamin D supplementation during orthodontic treatment | Experimental | The biological methods include using various chemicals like parathyroid hormone, thyroid hormone, prostaglandins, corticosteroids, relaxin and vitamin D.
Due to its important role in bone remodeling, vitamin D is hypothesized to play an important role in accelerating orthodontic tooth movement.
experimental group subjects with serum vitamin D levels in the range of 30-40 ng/ml are enrolled Receives: Drug: Calcitriol 0.25Mcg Cap; Procedure: orthodontic treatment |
| control : Orthodontic treatment with no intervention | Active comparator | control group subjects with serum vitamin D levels in the range of (30-40 ng/ml) are enrolled Receives: Procedure: orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measured: 4th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measured: 8th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measured: 12th week
Measurement of rate of canine retraction
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measured: 16th week
Secondary outcomes (1)
Measurement of Root resorption
Root resorption is measured in relation to canine with the help of CBCT taken before and after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start20 Nov 2019
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class IStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rekha Sharma, MDS, Study chair, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202496
- Sponsor's protocol ID
- Dr Revathi M N
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Systemic Administration of Vitamin D on the Rate of Orthodontic Tooth Movement - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05202496
- Acronym / sponsor ID
- Dr Revathi M N
- Conditions
- Angle Class I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Jan 2022 (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 study is to evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups with a sample size of 24 and having serum vitamin D level (30-40 ng/ml). All subjects undergo orthodontic levelling and alignment after premolar extractions followed by vitamin D supplementation in the experimental group. The rate of canine retraction will be measured in both the groups and CBCT taken in the interval of 6 months before and after intervention to measure root changes
Detailed description
Aims and Objectives: To evaluate the effect of vitamin D on the rate of tooth movement by measuring and comparing the extraction space closure during retraction in experimental (vitamin D supplemented) and control groups. Secondary objective: To compare root resorption in experimental and control group. Setting: Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.
Study Design: Prospective, double blind, randomized clinical study Time frame: Duration of study is one year Population/participant: Inclusion criteria:- Patients with age between 19-25 years with malocclusion requiring bilateral extraction of maxillary 1st premolars in good general health and healthy periodontium.
Exclusion Criteria:- Presence of any systemic/bone/metabolic/hormonal diseases, long-term drug history, pregnant or lactating women, smoking habit, root resorption orany chronic disorders Sample size: A sample size of 10 per group for the present study was calculated to detect a clinical difference of 0.89 with a pooled standard deviation of 0.53 (effect size 1.67) at 95% power and alpha significance level at 0.05.
To compensate for 20% dropouts the final sample size was calculated to be 11 per group (i.e) total sample size will be 24.
Method of study: Patients who fulfill the selection criteria will be selected for the study. After taking the pretreatment records and recording the pretreatment vitamin D levels the patients will be sent for extraction of 1st premolars. Treatment will be initiated by bonding 0.022"slot MBT straight wire appliance. Retraction will be done on 0.019"x 0.025" SS wires using closed coil NiTi springs. Patients of study group will be instructed to take adequate dose of vitamin D3 during phase of space closure. Serum vitamin D levels will be checked at 4th,8th, 12th and 16th weeks and rate of canine retraction will be measured at these time intervals. Root resorption will be measured from CBCT at the end of 6 months Outcome Measures: The outcome variables will be the rate of retraction measured in millimeters. Changes in root length will be measured and compared between the two groups Statistical Analysis: Data will be checked for normality. If it is in normal distribution, intra group comparison will be done by student's t-test between two time points and inter group comparison will be done by using Independent T test between two groups. If it is in non-normal distribution, intra group comparison will be done by Wilcoxon signed rank test and inter group comparison will be done by Mann-Whitney U test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: oral vitamin D supplementation during orthodontic treatment | Experimental | Drug: Calcitriol 0.25Mcg Cap, Procedure: orthodontic treatmentThe biological methods include using various chemicals like parathyroid hormone, thyroid hormone, prostaglandins, corticosteroids, relaxin and vitamin D. Due to its important role in bone remodeling, vitamin D is hypothesized to play an important role in accelerating orthodontic tooth movement. experimental group subjects with serum vitamin D levels in the range of 30-40 ng/ml are enrolled |
| control : Orthodontic treatment with no intervention | Active comparator | Procedure: orthodontic treatmentcontrol group subjects with serum vitamin D levels in the range of (30-40 ng/ml) are enrolled |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient in the age group of 19-25 years .
- Good general health status.
- Healthy periodontium
- Absence of root resorption.
- Absence of any chronic disorders
Key exclusion criteria (5 listed)
- Presence of any signs and symptoms of gingival and periodontal diseases.
- Any Systemic/Bone/metabolic/hormonal disease illness known to affect the outcome of orthodontic therapy or requiring administration of vitamin D
- Any kind of prolonged drug administration (chronic drug intake)
- Pregnant or lactating women.
- Smoking habit.
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 |
|---|---|---|
| Calcitriol 0.25Mcg CapAlso: RocaltrolAfter orthodontic levelling and alignment, experimental group subjects are administered one capsule of calcitriol 0.25 mcg on a daily basis during the study period. Also, serum vitamin D levels are monitored at monthly intervals and rate of canine retraction is measured at monthly intervals | Drug | Experimental: oral vitamin D supplementation during orthodontic treatment |
| orthodontic treatmentexperimental group subjects undergo orthodontic treatment after extraction of premolars | Procedure or surgery | Experimental: oral vitamin D supplementation during orthodontic treatment, control : Orthodontic treatment with no intervention |
Primary outcome
Measurement of rate of canine retraction
Time frame: 4th week
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measurement of rate of canine retraction
Time frame: 8th week
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measurement of rate of canine retraction
Time frame: 12th week
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
Measurement of rate of canine retraction
Time frame: 16th week
Distal movement of maxillary canine is measured in mm with the help of electric digital caliper after beginning of maxillary canine retraction
1 secondary outcome
Measurement of Root resorption
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Rekha Sharma, MDS study chair
PGIDS,ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitriol 0.25Mcg Cap and orthodontic treatment in people with Angle Class I, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 5 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: finished, as of the sponsor's last update on 21 Jan 2022. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of rate of canine retraction (time frame: 4th week). The study lists 4 primary outcomes in all. 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 21 Jan 2022.