A clinical trial comparing two different Orthodontic arch wires.

Phase 2/3

Not yet recruiting

Conditions: irregular teeth
Disorder of tooth development, unspecified,

Registration Number: CTRI/2020/03/024175

Lead Sponsor: Shubhangi jain

Brief Summary: The aim of the study is to clinically evaluate and compare two different initial aligning arch wires: conventional Ni-Ti and superelastic Ni-Ti in relation to the alignment efficiency, root resorption and pain intensity. The null hypothesis will be that there is no significant difference in the rate of alignment, pain intensity and root resorption during aligning phase using two different initial aligning archwires. The present study will be conducted in the Department of Orthodontics and Dentofacial orthopedics, I.T.S - Centre for Dental studies and research, Muradnagar, Uttar Pradesh, India. Twenty patients requiring fixed orthodontic treatment will be selected to participate in the study according to the following criteria:

**Inclusion criteria**

Patients aged 15-25 yrs of age.

Patients requiring fixed orthodontic treatment with extraction of 1st premolars.

Patients with crowding in lower anterior segment having a mandibular irregularity index 5-8.

Patients with no relevant medical history.

no recent history of intake of drugs such as non steroidal anti inflammatory drugs.

**Exclusion criteria**

Subjects with systemic diseases.

Patients with active periodontal disease

Patients who have undergone previous active orthodontic treatment.

Patients with spacing in the lower anterior region.

Patients with a blocked-out tooth that do not allow for placement of the bracket at the initial bonding appointment.

**Methodology:**The study will be conducted on 20 patients using two different initial aligning archwires i.e. conventional Ni-Ti (test group A) and superelastic Ni-Ti wire (test group B) for the alignment of the mandibular arches. All the patients selected for the study will receive MBT prescription with 0.022x0.028 inch slot size.

The rate of alignment will be assessed in the mandibular arch. Good quality alginate impressions will be taken at the pre-alignment phase. After the placement of bonded attachments and bands, the aligning archwire will be placed using elastomeric ligatures. The patient will be recalled every month and a good quality alginate impression will be taken. This procedure will be conducted till archwire does not show any deflection at any site anteriorly regardless of remaining buccal irregularities.

After the placement of initial aligning archwires, the patient will be asked to record the pain and discomfort after 24 hours and 1 week after the placement of the archwire on a visual analogue scale.

In this study pre treatment CBCT radiographs of the patients will be taken to determine the root length of mandibular anterior teeth. After the completion of the aligning phase of the treatment, a post-alignment CBCT will be done to assess the root resorption during the aligning phase.

The data will be tabulated and sent for statistical analysis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients requiring fixed orthodontic treatment with extraction of 1st premolars.
Patients with crowding in lower anterior segment having a mandibular irregularity index 5-8.
Patients with no relevant medical history.
no recent history of intake of drugs such as non-steroidal anti-inflammatory drugs.

Exclusion Criteria

Patients with systemic diseases, active periodontal disease, spacing in lower anterior region and those who had undergone previously orthodontic treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the aligning efficiency of 0.016 in superplastic Niti and 0.016 Heat activated niti	every 3 weeks till end of completely aligned.

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the pain due to 0.016 in superplastic Niti and 0.016 Heat activated niti in aligning phase	24 hrs and 1 week after placement of wire
To evaluate and compare the root resorption due to 0.016 in superplastic Niti and 0.016 Heat activated niti	before wire placement and post alignment

Trial Locations

Locations (1): I.T.S Dental college and research centre
🇮🇳
Ghaziabad, UTTAR PRADESH, India
I.T.S Dental college and research centre
🇮🇳Ghaziabad, UTTAR PRADESH, India
Shubhangi Jain
Principal investigator
9811344831
shubhangi.jain.92@gmail.com