CompletedNot Applicable

Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

Syria34 participantsStarted 2018-02-15

Plain-language summary

This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy. Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.

Who can participate

Age range

18 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

. Age range between 18 and 30 years.
. Class II division 1 malocclusion requiring extraction of upper first premolars.
. Mild to moderate skeletal class II malocclusion.
. Normal or excessive anterior facial height.
. No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
. Overjet \>5 mm and \<10 mm.
. Completion permanent dentition (regardless of third molars).
. No 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

Change in the levels of pain perception

Timeframe: Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

Change in the levels of discomfort perception

Timeframe: Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention

Trial details

NCT IDNCT05040945

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-31

View on ClinicalTrials.gov More Class II Division 1 Malocclusion trials

Plain-language summary

Who can participate

Age range

18 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

. Age range between 18 and 30 years.
. Class II division 1 malocclusion requiring extraction of upper first premolars.
. Mild to moderate skeletal class II malocclusion.
. Normal or excessive anterior facial height.
. No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
. Overjet \>5 mm and \<10 mm.
. Completion permanent dentition (regardless of third molars).
. No previous orthodontic treatment.

What they're measuring

Change in the levels of pain perception

Change in the levels of discomfort perception

Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria