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

NCT05144555 | Completed

• 1 other identifier: 2021-METCERIGIENE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Inflammation; Dental Malocclusion

Keywords

orthodontic brackets; ceramic brackets; stainless steel brackets; orthodontic fixed treatment; dental hygiene

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Group MET

EXPERIMENTAL

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

Other: Fixed orthodontic treatment with stainless steel brackets

Group CER

ACTIVE COMPARATOR

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

Other: Fixed orthodontic treatment with ceramic brackets

Interventions

Fixed orthodontic treatment with stainless steel brackets 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 MET

Fixed orthodontic treatment with ceramic brackets 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.

Group CER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
• full permanent dentition;
• all teeth from central incisors to second premolars.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 3, 2021
• Study Start: December 18, 2021
• Primary Completion: September 9, 2024
• Study Completion: September 10, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)