CompletedNot Applicable

To Compare the Effects of Lip Bumper Appliance in Rate of Lower Incisor Alignment After First Premolar Extractions

Pakistan44 participantsStarted 2025-03-01

Plain-language summary

The goal of this clinical trial is to check the effects of lip bumper appliance contribution to driftodontics after designated tooth extractions that are already part of orthodontic treatment plan. The main questions it aims to answer are: * Is there a significant difference in rate of incisor alignment in lip bumper group? * Does the lip bumper have any adverse effects on oral hygiene? Researchers will compare the effects of appliance vs no appliance. Participants will have: * Appliance cemented in mouth after extractions in interventional group and no appliance in control group * Three monthly follow up for checkup and impressions

Who can participate

Age range

13 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A treatment plan involving bilateral extractions of maxillary and mandibular first premolars * Patients with class 1 and upto quarter cusp class 2 molar relationship * Moderate to severe incisor irregularity of 4-9 mm as assessed by little's irregularity index * Presence of all first molars Exclusion Criteria: * Developmental, medical or genetic problems * Patients using bisphosponates * Spacing in dentition * Carious lesion in lower first molars which cannot be restored * Patient with active periodontal disease * Previous orthodontic treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To compare the rate of lower incisor alignment in orthodontic patients undergoing lip bumper treatment and control group after all first premolar extractions

Timeframe: 3 months

Trial details

NCT IDNCT06929754

SponsorBahria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-16

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