CompletedNot Applicable

Periodontal Parameters in Orthodontic Patients With Stainless Steel and Ceramic Brackets.

Italy20 participantsStarted 2021-12-18

Plain-language summary

The aim of this study is to assess if there are significant differences in periodontal conditions between patients undergoing fixed orthodontic treatment with stainless steel or ceramic brackets. For this study, patients will be enrolled and divided into two groups, according to the type of brackets (stainless steel or ceramic) used for orthodontic treatment. A professional supragingival and subgingival oral hygiene will be performed before the bonding of the orthodontic brackets together with a periodontal evaluation will be recording the following periodontal indices: PPD, BoP, BS, GI, PI, BEWE and Schiff Air Index. Indices will be recorded after 1, 3 and 6 months after the bonding, separately for both in maxillary and in mandibular dental arches and only for teeth with brackets bonded.

Who can participate

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: * patients willing to begin fixed multibracket therapy with metallic or ceramic brackets; * full permanent dentition; * all teeth from central incisors to second premolars. Exclusion Criteria: * patients suffering from systemic diseases; * patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.); * patients with low compliance; * patients unable to give informed consent; * presence of congenital enamel defects; * extractions for orthodontic reasons; * oral/orthognathic surgery; * presence of dental implants on teeth from central incisors to second premolars.

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 GI - Gingival Index (Loe and Silness, 1963)

Timeframe: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Change in BS - Bleeding Score

Timeframe: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Change in PI - Plaque Index (Silness and Löe, 1964)

Timeframe: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental archesBefore the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Change in BEWE index (Basic Erosive Wear Examination)

Change in Schiff Air Index - sensitivity score

Trial details

NCT IDNCT05144555

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-09

View on ClinicalTrials.gov More Periodontal Inflammation trials

Plain-language summary

Who can participate

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.

What they're measuring

Change in GI - Gingival Index (Loe and Silness, 1963)

Timeframe: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Change in BS - Bleeding Score

Timeframe: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Change in PI - Plaque Index (Silness and Löe, 1964)

Change in BEWE index (Basic Erosive Wear Examination)

Change in Schiff Air Index - sensitivity score