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Changes in the positions of lower front teeth and pain experience with two types of wires used in fixed braces for the treatment of irregular teeth.

Evaluation of the lower incisor inclination control and perceived pain during alignment and levelling with round and braided-rectangular Nickel-Titanium initial archwire in mild to moderate crowding cases. A Randomized Controlled Trial. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084552
Enrollment
38
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: 0.017 x 0.025-inch braided NiTi archwire: All the patients will be bonded with 0.18 Slot MBT prescription brackets and tubes using the standard bonding protocol. The 0.017 x 0.025-inch

Sponsors

DrTamal Das Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Littles irregularity index of 3 to 6 mm in lower anteriors with no more than 2 mm for any contact 2. Curve of Spee of 3-5 mm

Exclusion criteria

Exclusion criteria: 1. Known Nickel allergy 2. Systemic diseases or medications influencing tooth movement or bone metabolism 3. Attached gingiva in any anterior tooth less than 1.5 mm 4. Clinical attachment loss of more than 1 mm in any tooth 5. History of previous orthodontic treatment

Design outcomes

Primary

MeasureTime frame
I. Incisor position change This will be assessed using lateral cephalograms and estimated with the following variables Linear variables (in mm) 1. L1i to NB 2. L1i to SN perpendicular at S 3. L1a to SN perpendicular at S 4. L1 Incisal tip movement or L1 apex movement 5. L1i to Go-Me 6. L1i to SN Angular variables (in degrees) 1. L1 to NB 2. IMPA II. Perceived pain as reported by the participant on a 100 mm long Visual Analogue Scale. The number of 500 mg Paracetamol tablets consumed by the patient during the assessment period will also be estimated and used as a second marker of perceived pain Timepoint: Incisor position changes will be assessed using lateral cephalogram at Baseline and after eight weeks Perceived pain will be recorded at 3 hours, 8 hours, and 1, 3, 5, 7, 15 and 30th day after insertion of archwire.

Secondary

MeasureTime frame
1. Alignment efficiency, estimated as the calculated as the change in Littles irregularity index (in mm) divided by the duration of assessment (in months) 2. Leveling Efficiency, estimated as the change in Curve of Spee (in mm) divided by the duration of assessment (in months) 3. Bond failures, recorded as the total number of bond failures during the entire study period.Timepoint: T0- At Baseline T1- After eight weeks

Countries

India

Contacts

Public ContactBalasubramanian Madhan

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

JD1128@jipmer.ac.in9498066130

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026