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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05144555
Other study ID # 2021-METCERIGIENE
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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