Periodontal InflammationNCT05144555
Periodontal Parameters in Orthodontic Patients With Stainless Steel and Ceramic Brackets.
A study testing Fixed orthodontic treatment with stainless steel brackets and Fixed orthodontic treatment with ceramic brackets in people with Periodontal Inflammation and Dental Malocclusion, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation, Dental Malocclusion
- What is being tested?
- Fixed orthodontic treatment with stainless steel brackets and Fixed orthodontic treatment with ceramic brackets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2021to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
- full permanent dentition;
- all teeth from central incisors to second premolars.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.
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.
Read the 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.
- Conditions
- Periodontal Inflammation, Dental Malocclusion
- Being tested
- Fixed orthodontic treatment with stainless steel brackets, Fixed orthodontic treatment with ceramic brackets
- Keywords
- orthodontic brackets, ceramic brackets, stainless steel brackets, orthodontic fixed treatment, dental hygiene
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed orthodontic treatment with stainless steel bracketsOther
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 bracketsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group MET | Experimental | Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets. Receives: Other: Fixed orthodontic treatment with stainless steel brackets |
| Group CER | Active comparator | Patients from this group will undergo orthodontic fixed treatment with ceramic brackets. Receives: Other: Fixed orthodontic treatment with ceramic brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches
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
Measured: Before the bonding procedure; after 1, 3 and 6 months after the bonding both in maxillary and in mandibular dental arches
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: 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
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%.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start18 Dec 2021
- Primary completion9 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144555
- Sponsor's protocol ID
- 2021-METCERIGIENE
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Evaluation in Patients Undergoing Fixed Orthodontic Treatment With Stainless Steel or Ceramic Brackets: a Clinical Trial.
- ClinicalTrials.gov ID
- NCT05144555
- Acronym / sponsor ID
- 2021-METCERIGIENE
- Conditions
- Periodontal Inflammation, Dental Malocclusion
- Keywords
- orthodontic brackets, ceramic brackets, stainless steel brackets, orthodontic fixed treatment, dental hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MET | Experimental | Other: Fixed orthodontic treatment with stainless steel bracketsPatients from this group will undergo orthodontic fixed treatment with stainless steel brackets. |
| Group CER | Active comparator | Other: Fixed orthodontic treatment with ceramic bracketsPatients from this group will undergo orthodontic fixed treatment with ceramic brackets. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
- full permanent dentition;
- all teeth from central incisors to second premolars.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed orthodontic treatment with stainless steel bracketsStainless 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. | Other | Group MET |
| Fixed orthodontic treatment with ceramic bracketsCeramic 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. | Other | Group CER |
Primary outcome
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 BEWE index (Basic Erosive Wear Examination)
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 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
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
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
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
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)
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
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator.
Related trials for Periodontal Inflammation
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
RecruitingObservational study
Association of Periodontal Inflammation on Immune Response in Wound Healing
Inflammation of Mouth
Not yet recruiting
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
Autism Disorder, Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed orthodontic treatment with stainless steel brackets and Fixed orthodontic treatment with ceramic brackets in people with Periodontal Inflammation and Dental Malocclusion, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.