CompletedNot Applicable

Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion

Syria38 participantsStarted 2015-02-15

Plain-language summary

The aim of this study is to evaluate the levels of pain, discomfort and acceptance between two treatment modalities of Class III correction of growing patients in the late mixed dentition period.

Who can participate

Age range

9 Years – 12 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

. Class III malocclusion according to Angle
. Presence of anterior cross bite on two teeth or more
. Class III Skeletal relationship confirmed radiographically (-4\<ANB\<+1)
. The lower incisors have normal inclination (Incisor-Mandibular-Plane angle not exceeding 100° and not less than 85°)
. Late mixed dentition or the beginning of the permanent dentition
. Eruption of The lower canines and first premolars on both sides
. Absence of craniofacial syndromes or cleft lip and/or palate abnormalities
. no supernumerary teeth or missing teeth except for the third molars

Exclusion criteria

. Pure maxillary deficiency
. Pure mandibular prognathism
. Diseases that prevent the application of mini-implants (e.g. Osteoporosis- cortisone and its derivatives treatment - radiation)

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

Change in the sensation of tension or pressure

Timeframe: Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)

Change in the perception of pain

Change in the perception of speech

Change in swallowing ability

Change in mandibular restriction

Trial details

NCT IDNCT03976635

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10-01

View on ClinicalTrials.gov More Class III Malocclusion trials