Mild to Moderate Anterior Mandibular Segment CrowdindPhase 2/3NCT05560919
Acceleration of Orthodontic Tooth Movement
A Phase 2/3 study testing Dihydroxycholecalciferols, dimethyl sulfoxide and serum in people with Mild to Moderate Anterior Mandibular Segment Crowdind, run by Latakia University at 1 site in Syria.
Trial summary
EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Mild to Moderate Anterior Mandibular Segment Crowdind
- What is being tested?
- Dihydroxycholecalciferols, dimethyl sulfoxide and serum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSyria
- Study dates
- 20 Sep 2021to 25 Jun 2022
- Phase
- Phase 2/3
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
- Healthy patient
- No previous orthodontic treatment
- Vital teeth with periodental tissue without root absorption,
Who cannot join
- Previous history of orthodontic or orthopedic treatment.
- Presence of craniofacial anomalies.
- Presence of any signs and symptoms of gingival and periodontal diseases.
- Presence of significant medical history (including drug allergy).
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Efficacy of Locally Injected Vitamin D3 (Calcitriol or 1,25 Dihidroxicolecalciferol) in Accelerating Orthodontic Tooth Movement (A Randomized Controlled Trial)
EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.
Read the detailed description
The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.
There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.
- Being tested
- Dihydroxycholecalciferols, dimethyl sulfoxide, serum
- Keywords
- Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydroxycholecalciferolsDrug
Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.
dimethyl sulfoxideOther
Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.
serumOther
Injection of serum in the periodontal ligament for lower anterior segment teeth.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale Receives: Drug: Dihydroxycholecalciferols |
| Group 2 | Experimental | Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale. Receives: Other: dimethyl sulfoxide |
| Group 3 | Experimental | Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale. Receives: Other: serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch
To calculate outcome measures, a mandible alginate impression was taken to make study casts at three time points:
before insertion of the first archwire (T0), after 1 month of treatment commencement (T1), and at the end of the leveling and alignment stage (T2), represented by final archwire insertion.
LII was used to measure the change in tooth alignment on the casts. It involved measuring the horizontal linear distance among adjacent contact points of the six anterior teeth. The sum of these five measurements gave the value of the index. LII was measured using a digital caliper to the nearest 0.01 mm by the corresponding author.
OLAT was calculated by the number of days between T0 and T2.
Measured: 6 months
Secondary outcomes (2)
Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.
OLAT was calculated by the number of days between T0 and T2. LAIP was calculated by dividing the amount of change in the LII value at a specific time point (T1, T2 ; calculated by subtracting the LII value at T1, T2 from the LII value at T0) by Lll value at T0. OLAT was calculated by the number of days between T0 and T2.
LAIP was calculated by dividing the amount of change in the LII value at a specific time point (T1, T2 ; calculated by subtracting the LII value at T1, T2 from the LII value at T0) by Lll value at T0.
Measured: 6 months
VAS scale
to measure patient pain or discomfort
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start20 Sep 2021
- Primary completion30 Apr 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Anterior Mandibular Segment CrowdindStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560919
- Sponsor's protocol ID
- Tishreen U _Orthodontics
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Informed Consent Form
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy of Locally Injected Vitamin D3 (Calcitriol or 1,25 Dihidroxicolecalciferol) in Accelerating Orthodontic Tooth Movement (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05560919
- Acronym / sponsor ID
- Tishreen U _Orthodontics
- Keywords
- Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 30 Sep 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.
EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.
Detailed description
The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.
There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: DihydroxycholecalciferolsSix participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale |
| Group 2 | Experimental | Other: dimethyl sulfoxideSix participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale. |
| Group 3 | Experimental | Other: serumSix participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
- Healthy patient
- No previous orthodontic treatment
- Vital teeth with periodental tissue without root absorption,
Key exclusion criteria (5 listed)
- Previous history of orthodontic or orthopedic treatment.
- Presence of craniofacial anomalies.
- Presence of any signs and symptoms of gingival and periodontal diseases.
- Presence of significant medical history (including drug allergy).
- Pregnant and lactating women.
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 |
|---|---|---|
| DihydroxycholecalciferolsInjection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth. | Drug | Group 1 |
| dimethyl sulfoxideInjection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth. | Other | Group 2 |
| serumInjection of serum in the periodontal ligament for lower anterior segment teeth. | Other | Group 3 |
Primary outcome
Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch
Time frame: 6 months
To calculate outcome measures, a mandible alginate impression was taken to make study casts at three time points: before insertion of the first archwire (T0), after 1 month of treatment commencement (T1), and at the end of the leveling and alignment stage (T2), represented by final archwire insertion. LII was used to measure the change in tooth alignment on the casts. It involved measuring the horizontal linear distance among adjacent contact points of the six anterior teeth. The sum of these five measurements gave the value of the index. LII was measured using a digital caliper to the nearest 0.01 mm by the corresponding author. OLAT was calculated by the number of days between T0 and T2.
2 secondary outcomes
Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.
Time frame: 6 months
VAS scale
Time frame: 3 weeks
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 30 Sep 2022.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent Form
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dihydroxycholecalciferols, dimethyl sulfoxide and serum in people with Mild to Moderate Anterior Mandibular Segment Crowdind, run by Latakia University at 1 site in Syria.
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 4 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 30 Sep 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 Syria. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch (time frame: 6 months). 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 30 Sep 2022.