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

NCT ID: NCT05144555

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-18

Study Completion Date

2024-09-10

Brief Summary

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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.

Detailed Description

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This clinical trial aims to investigate if there are significant differences in periodontal conditions between patients undergoing fixed orthodontic treatment with stainless steel or ceramic brackets. Patients recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients. A professional supragingival and subgingival oral hygiene will be performed before the bonding of the orthodontic brackets; a piezoelectric instrument and Gracey curettes will be used. After that, patients will be divided into two groups:

* Group MET: stainless steel brackets will be bonded on the vestibular surfaces of teeth.
* Group CER: ceramic brackets will be bonded on the vestibular surfaces of teeth. Before the bonding on maxillary dental arch, a periodontal evaluation will be conducted 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. Only teeth with brackets bonded will be considered.

Conditions

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Periodontal Inflammation Dental Malocclusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group MET

Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.

Group Type EXPERIMENTAL

Fixed orthodontic treatment with stainless steel brackets

Intervention Type OTHER

Stainless steel brackets (Queen Series Low Profile Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth to perform orthodontic treatment.

Group CER

Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.

Group Type ACTIVE_COMPARATOR

Fixed orthodontic treatment with ceramic brackets

Intervention Type OTHER

Ceramic brackets (Super Clear Series Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth to perform orthodontic treatment.

Interventions

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Fixed orthodontic treatment with stainless steel brackets

Stainless steel brackets (Queen Series Low Profile Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth to perform orthodontic treatment.

Intervention Type OTHER

Fixed orthodontic treatment with ceramic brackets

Ceramic brackets (Super Clear Series Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth to perform orthodontic treatment.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2021-METCERIGIENE

Identifier Type: -

Identifier Source: org_study_id

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