Clinical trial NCT05144555: Periodontal Parameters in Orthodontic Patients With Stainless Steel and Ceramic Brackets.
Official title: Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Dental Malocclusion
Keywords: orthodontic brackets
ceramic brackets
stainless steel brackets
orthodontic fixed treatment
dental hygiene
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Change in GI - Gingival Index (Loe and Silness, 1963)
timeFrame: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches
measure: Change in BS - Bleeding Score
timeFrame: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches
measure: Change in PI - Plaque Index (Silness and Löe, 1964)
timeFrame: 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
measure: Change in BEWE index (Basic Erosive Wear Examination)
timeFrame: 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
measure: Change in Schiff Air Index - sensitivity score
timeFrame: 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
measure: Change in PPD - Probing Pocket Depth
timeFrame: 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
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: