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

Study Overview
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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.

Official Title
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Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.

Conditions
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Periodontal Inflammation, Dental Malocclusion

Intervention / Treatment
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* Other: Fixed orthodontic treatment with stainless steel brackets
* Other: Fixed orthodontic treatment with ceramic brackets


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group MET<br>Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets. | Other: Fixed orthodontic treatment with stainless steel brackets<br>* 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.<br>|
| Active Comparator: Group CER<br>Patients from this group will undergo orthodontic fixed treatment with ceramic brackets. | Other: Fixed orthodontic treatment with ceramic brackets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GI - Gingival Index (Loe and Silness, 1963) | Scoring criteria: 0 = normal gingiva 1 = mild inflammation, edema and swelling; no bleeding 2 = moderate inflammation with edema, swelling and bleeding on probing 3= severe inflammation with marked edema, redness, tissues, ulceration and spontaneous bleeding | 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 | Scoring criteria: 0 = no bleeding 1 = punctiform bleeding in the site of probing 2 = slightly extended bleeding in the site of probing 3 = bleeding in more than a half of gingival margin 4= gingival border fully covered by blood | 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) | Scoring criteria: 0 = no plaque 1 = thin plaque layer at the gingival margin, only detectable by scraping with a probe 2 = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye 3= abundant plaque along the gingival margin; interdental spaces filled with plaque | 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) | Scoring criteria: 0 = no ETW (erosive tooth wear) 1 = initial loss of surface texture 2 = distinct defect; hard tissue loss involving <50% of the surface area 3 = hard tissue loss involving ≥50% of the surface area | 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 Schiff Air Index - sensitivity score | Evaluation criteria with the visual analog scale (VAS). The patient indicates the pain level on the scale of 0-10 | 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 PPD - Probing Pocket Depth | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | 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 BOP - Bleeding on Probing (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe. Percentage of sites with bleeding on probing determines the BOP%. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental hygiene, orthodontic brackets, ceramic brackets, stainless steel brackets, orthodontic fixed treatment