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

Not Applicable

Completed

• Conditions: Dental Malocclusion; Periodontal Inflammation
• Interventions: Other: Fixed orthodontic treatment with ceramic brackets; Other: Fixed orthodontic treatment with stainless steel brackets

• Registration Number: NCT05144555
• Lead Sponsor: University of Pavia

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-11-20
• Study First Posted: 2021-12-03
• Study Start: 2021-12-18
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CER	Fixed orthodontic treatment with ceramic brackets	Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.
Group MET	Fixed orthodontic treatment with stainless steel brackets	Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.

Primary Outcome Measures

Name	Time	Method
Change in GI - Gingival Index (Loe and Silness, 1963)	Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches	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
Change in BS - Bleeding Score	Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches	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
Change in PI - Plaque Index (Silness and Löe, 1964)	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	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
Change in PPD - Probing Pocket Depth	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	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.
Change in BEWE index (Basic Erosive Wear Examination)	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	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
Change in Schiff Air Index - sensitivity score	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	Evaluation criteria with the visual analog scale (VAS). The patient indicates the pain level on the scale of 0-10
Change in BOP - Bleeding on Probing (percentage)	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	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%.

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy