Clinical Trials/NCT05144555

NCT05144555

Completed

Not Applicable

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

University of Pavia1 site in 1 country20 target enrollmentDecember 18, 2021

ConditionsPeriodontal Inflammation Dental Malocclusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Periodontal Inflammation
Sponsor: University of Pavia
Enrollment: 20
Locations: 1
Primary Endpoint: Change in GI - Gingival Index (Loe and Silness, 1963)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

December 18, 2021

End Date

September 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pavia

Responsible Party

Principal Investigator

Andrea Scribante

Research Resident, Principal Investigator

University of Pavia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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

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.

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

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

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%.