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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Fixed orthodontic treatment with stainless steel brackets

Fixed orthodontic treatment with ceramic brackets

About this trial

This is an interventional diagnostic trial for Periodontal Inflammation focused on measuring orthodontic brackets, ceramic brackets, stainless steel brackets, orthodontic fixed treatment, dental hygiene

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group MET

Group CER

Arm Description

Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.

Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.

Outcomes

Primary Outcome Measures

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

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

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

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 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 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%.

Secondary Outcome Measures

Full Information

NCT ID

NCT05144555

First Posted

November 20, 2021

Last Updated

October 4, 2023

Sponsor

University of Pavia

1. Study Identification

Unique Protocol Identification Number

NCT05144555

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 18, 2021 (Actual)

Primary Completion Date

December 9, 2023 (Anticipated)

Study Completion Date

December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Inflammation, Dental Malocclusion

Keywords

orthodontic brackets, ceramic brackets, stainless steel brackets, orthodontic fixed treatment, dental hygiene

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group MET

Arm Type

Experimental

Arm Description

Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets.

Arm Title

Group CER

Arm Type

Active Comparator

Arm Description

Patients from this group will undergo orthodontic fixed treatment with ceramic brackets.

Intervention Type

Other

Intervention Name(s)

Fixed orthodontic treatment with stainless steel brackets

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Fixed orthodontic treatment with ceramic brackets

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in GI - Gingival Index (Loe and Silness, 1963)

Description

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

Time Frame

Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Title

Change in BS - Bleeding Score

Description

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

Time Frame

Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches

Title

Change in PI - Plaque Index (Silness and Löe, 1964)

Description

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

Time Frame