Improvement in Class II Molar Relationship Among Orthodontic Patients Reminded Through Text Message and Phone Call as Compared to No Reminders for Wearing Class II Elastics -A Randomized Controlled Trial

NCT06746090 | Completed

• 1 other identifier: 2023-8830-26873
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the difference in improvement in class II molar relationship among orthodontic patients reminded daily through text message, weekly through phone call as compared to no reminders for wearing class II elastics.

Conditions

Compliance, Patient

Keywords

Class II elastics; reminders; molar relationship

Outcome Measures

Primary Outcomes (1)

• Improvement in class II molar relationship by using an overjet scale among orthodontic patients through reminders.

  Reminders will be given daily through text message, weekly through phone call as compared to no reminders for wearing class II elastics. An overjet scale consisting of markings in mm will be used to measure the distance from mesial of the band of lower first permanent mandibular molar to cusp tip of upper canine.

  6 months

Study Arms (3)

Reminders for wearing class II elastics through text message

EXPERIMENTAL

Reminders daily via whatsapp text message.

Behavioral: Reminders

Reminders for wearing class II elastics through phone call

EXPERIMENTAL

Reminders weekly via phone call.

Behavioral: Reminders

No reminders for wearing class II elastics

NO INTERVENTION

No reminder for wearing elastics.

Interventions

Reminders BEHAVIORAL

Group A(Intervention): Patients who will be reminded daily via whatsapp text message. Group B(Intervention): Patients who will be asked through a weekly phone call about elastic wear and then motivated.

Reminders for wearing class II elastics through phone call; Reminders for wearing class II elastics through text message

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 15 - 50 years with permanent dentition.
• Patients undergoing fixed orthodontic treatment and requires class II elastics for correcting molar relationship as a part of their treatment plan.
• All patients who will sign the informed consent form.
• Patients having access to smartphones.

You may not qualify if:

• Patients with uncontrolled periodontal disease or pulpitis.
• Presence of any dental/ craniofacial anomaly or syndrome like hemifacial microsomia, Downs syndrome, Treacher Collins syndrome, etc

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Afeefa Abul Barakaat

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rashna R Hoshang Sukhia, BDS, FCPS

  Aga Khan University Hospital, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be assigned to one of the three study groups using a computer generated randomization list. There will be no blinding in the study. The recruitment of the patients will be performed by the investigator who will explain the objective, the three arms of the study and the allocation to the participants. Allocation concealment will be carried out using opaque concealed envelopes which will be opened until the use of intervention is to be explained to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: December 24, 2024
• Study Start: January 3, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

PA (1)