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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Malocclusion; Periodontal Inflammation
• Intervention / Treatment: Other: Fixed orthodontic treatment with stainless steel brackets; Other: Fixed orthodontic treatment with ceramic brackets

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group CER; Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.	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.
Experimental: Group MET; Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Estimated): July 9, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: November 20, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ceramic brackets; dental hygiene; orthodontic brackets; stainless steel brackets; orthodontic fixed treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Inflammation; Malocclusion
• Other Study ID Numbers: 2021-METCERIGIENE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No