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Completed

NCT Number: NCT05144555

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

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.

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Key information

Conditions

Periodontal Inflammation Dental Malocclusion Malocclusion Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in GI - Gingival Index (Loe and Silness, 1963)

    Time frame: 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

  2. Change in BS - Bleeding Score

    Time frame: 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

  3. Change in PI - Plaque Index (Silness and Löe, 1964)

    Time frame: 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

  4. Change in BEWE index (Basic Erosive Wear Examination)

    Time frame: 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

  5. Change in Schiff Air Index - sensitivity score

    Time frame: 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

  6. Change in PPD - Probing Pocket Depth

    Time frame: 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.

  7. Change in BOP - Bleeding on Probing (percentage)

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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