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

Periodontal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05144555
• Other study ID #: 2021-METCERIGIENE
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: July 10, 2024

Study information

• Verified date: February 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 10, 2024
• Est. primary completion date: July 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Malocclusion
• Inflammation
• Malocclusion
• Periodontal Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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