Health Condition 1: M263- Anomalies of tooth position of fully erupted tooth or teeth
Conditions
Interventions
Intervention1: 4-week: Patients will be recalled every 4 weeks for their follow-up.
Control Intervention1: 6-week: Patients will be recalled every 6 weeks for their follow-up.
Control Intervention2: 8
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: permanent dentition, Angles Class I, II or III malocclusion requiring comprehensive orthodontic treatment, exhibit crowding of either arch with at least 4 mm in Littles Irregularity Index, good general health, adequate oral hygiene or capacity to improve following instructions, willing to or able to attend recall visits within or before 3 days of scheduled appointment date
Exclusion criteria
Exclusion criteria: systemic disease known to affect bone metabolism, medication intake which can significantly influence bone turnover, syndromic or congenital craniofacial abnormality, severely resorbed roots, compromised tooth vitality, severe skeletal discrepancy with planned orthognathic surgery, unilateral or atypical extraction plan, impacted tooth requiring surgical exposure and orthodontic extrusion and individuals enrolled in other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the time required to complete the leveling and aligning phase, defined as the number of days from bracket bonding to the first visit at which the phase completion criteria of LII equaling 0mm and passive engagement of 0.019x0.025 Stainless Steel archwire are simulataneously satisfiedTimepoint: patients will be recalled every 4-, 6-, 8- or 10- weeks for their appointments according to their allotted group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Alignment progression rate in millimetres per month, calculated from serial LII measurements at each appointment visitTimepoint: baseline & Phase completion;2. Incisor positional changes assessed on lateral cephalometric radiographs taken at baseline & phase completion, including incisor inclination, sagittal position relative to skeletal landmarks, & vertical position changesTimepoint: Baseline & Phase completion;3. Patient reported outcomes, including - pain & discomfort assessment using 10-point scale, OHIP-14 measurement, treatment satisfactionTimepoint: For pain, at baseline, after 1 week of initial appointment, & at every scheduled appointment, for OHIP - baseline, 1 month, 3 months & phase completion, & for treatment satisfaction after 3 months & phase completion;4. Periodontal health indicators including the Gingival Health Index on a severity scale of 0 - 3Timepoint: recorded at baseline, at every scheduled appointment & at phase completion;5. Iatrogenic effects, comprising of: Root resorption, WSL, Bracket or attachment failuresTimepoint: Root resorption recorded at baseline & at phase completion. White spot lesion - at baseline, at each scheduled appointment & at phase completion. Bracket or attachment failures recorded at each appointment | — |
Countries
India
Contacts
Public ContactPavithranand Ammayappan
Indira Gandhi Institute of Dental Sciences
Outcome results
None listed