Mild to Moderate Anterior Mandibular Segment Crowdind
Conditions
Keywords
Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
Brief 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.
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.
Interventions
DRUGDihydroxycholecalciferols
Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.
OTHERdimethyl sulfoxide
Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.
OTHERserum
Injection of serum in the periodontal ligament for lower anterior segment teeth.
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
Intervention model description
Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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,
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage. | 6 months | 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. |
| VAS scale | 3 weeks | to measure patient pain or discomfort |
Countries
Syria
Outcome results
None listed