GingivitisNCT06291129
Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents
A study testing Periodontal therapy in people with Gingivitis and Periodontal Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontal Diseases, Diabetes
- What is being tested?
- Periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2022to 30 Oct 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- child or adolescent with the age between 8 and 18 years old
Who cannot join
- child or adolescent who had an active or inactive caries lesion, on the buccal surface, in the cervical region of the elements to be analyzed;
- participants with probing depth greater than or equal to 4 mm, which is characterized as periodontitis;
- the patient who is undergoing orthodontic treatment, with fixed appliance;
- smokers;
- pregnant women, nursing mothers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Nova Friburgo, Rio de Janeiro, 28625650
About this study
Official title: Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.
Read the detailed description
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children (age 8 to 18 years old), who were distributed into two groups: patients with type 1 diabetes (DM; n=18) and control patients without diabetes (NDM; n=18). Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion, its prevalence, severity and need of treatment were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.
- Conditions
- Gingivitis, Periodontal Diseases, Diabetes, Diabetes Mellitus, Type 1, Malocclusion, Malocclusion in Children
- Being tested
- Periodontal therapy
- Medical subject headings
- Gingivitis, Periodontal Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 1, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal therapyProcedure or surgery
Supragingival scaling sessions were performed with ultrasonic scalers (Dabi Atlante, Rio de Janeiro, RJ, Brazil) to remove all calculus and biofilms, in addition to oral hygiene guidelines, including brushing technique and interdental cleaning with dental floss.
| Study group | Role | What they receive |
|---|---|---|
| Hematological and Periodontal Parameters | Other | Hematological parameters were recorded - fasting blood glucose and glycosylated hemoglobin - to confirm the allocation of each participant between the groups: diabetic (DM) and control (NDM). The clinical periodontal parameters, including plaque index (PI) and bleeding on probing (GI) full mouth (Ainamo \& Bay 1975), and plaque index (PI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. For the periodontal parameters' examination, a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL) was used, excluding third molars and erupting teeth. The intraexaminer agreement of the categorical variables (CAL) using the kappa calculation was 7.64, at the tooth level. Receives: Procedure: Periodontal therapy |
| Orthodontic Parameters | No intervention | The clinical orthodontic parameters were recorded by the Angle's Classification, witch evaluated occlusion of right and left canines and molars, and the Dental Aesthetic Index (DAI) that evaluates the prevalence of malocclusions, its severity and the need for treatment. DAI aspects evaluated were: upper teeth loss, lower teeth loss, crowding, spacing, diastema, maxillary misalignment, mandibular misalignment, anterior maxillary overjet, anterior mandibular overjet, anterior open bite, molar relationship. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Bleeding levels on probing below 10% of the periodontal sites evaluated.
Measured: Twenty-one days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start30 Oct 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
- Investigators
- Gabriela C Cruz, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291129
- Sponsor's protocol ID
- CAAE: 61347422.4.0000.5626
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oral Hygiene, Gingival Health, and Malocclusion Among Type 1 Diabetic Children and Adolescents: an Original Article
- ClinicalTrials.gov ID
- NCT06291129
- Acronym / sponsor ID
- CAAE: 61347422.4.0000.5626
- Conditions
- Gingivitis, Periodontal Diseases, Diabetes, Diabetes Mellitus, Type 1, Malocclusion, Malocclusion in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 4 Mar 2024 (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.
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.
Detailed description
Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children (age 8 to 18 years old), who were distributed into two groups: patients with type 1 diabetes (DM; n=18) and control patients without diabetes (NDM; n=18). Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion, its prevalence, severity and need of treatment were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematological and Periodontal Parameters | Other | Procedure: Periodontal therapyHematological parameters were recorded - fasting blood glucose and glycosylated hemoglobin - to confirm the allocation of each participant between the groups: diabetic (DM) and control (NDM). The clinical periodontal parameters, including plaque index (PI) and bleeding on probing (GI) full mouth (Ainamo \& Bay 1975), and plaque index (PI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters were evaluated by three aspects: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. For the periodontal parameters' examination, a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL) was used, excluding third molars and erupting teeth. The intraexaminer agreement of the categorical variables (CAL) using the kappa calculation was 7.64, at the tooth level. |
| Orthodontic Parameters | No intervention | –The clinical orthodontic parameters were recorded by the Angle's Classification, witch evaluated occlusion of right and left canines and molars, and the Dental Aesthetic Index (DAI) that evaluates the prevalence of malocclusions, its severity and the need for treatment. DAI aspects evaluated were: upper teeth loss, lower teeth loss, crowding, spacing, diastema, maxillary misalignment, mandibular misalignment, anterior maxillary overjet, anterior mandibular overjet, anterior open bite, molar relationship. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- child or adolescent with the age between 8 and 18 years old
Key exclusion criteria (5 listed)
- child or adolescent who had an active or inactive caries lesion, on the buccal surface, in the cervical region of the elements to be analyzed;
- participants with probing depth greater than or equal to 4 mm, which is characterized as periodontitis;
- the patient who is undergoing orthodontic treatment, with fixed appliance;
- smokers;
- pregnant women, nursing mothers.
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 |
|---|---|---|
| Periodontal therapySupragingival scaling sessions were performed with ultrasonic scalers (Dabi Atlante, Rio de Janeiro, RJ, Brazil) to remove all calculus and biofilms, in addition to oral hygiene guidelines, including brushing technique and interdental cleaning with dental floss. | Procedure or surgery | Hematological and Periodontal Parameters |
Primary outcome
Bleeding on probing
Time frame: Twenty-one days
Bleeding levels on probing below 10% of the periodontal sites evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Gabriela C Cruz, PhD principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal therapy in people with Gingivitis and Periodontal Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. 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 Brazil. 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?
Results are not available in the source record.
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?
Bleeding on probing (time frame: Twenty-one days). 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 4 Mar 2024.