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

Sponsor
University of Pavia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05144555
Collaborator
(none)
20
1
2
21.2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fixed orthodontic treatment with stainless steel brackets
  • Other: Fixed orthodontic treatment with ceramic brackets
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.
Actual Study Start Date :
Dec 18, 2021
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Sep 24, 2023

Arms and Interventions

Arm Intervention/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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Pavia Lombardy Italy 27100

Sponsors and Collaborators

  • University of Pavia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Scribante, Research Resident, Principal Investigator, University of Pavia
ClinicalTrials.gov Identifier:
NCT05144555
Other Study ID Numbers:
  • 2021-METCERIGIENE
First Posted:
Dec 3, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Scribante, Research Resident, Principal Investigator, University of Pavia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022