Periodontal Inflammation Clinical Trial
Official title:
Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.
Verified date | February 2024 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Pavia |
Italy,
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 |
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