The oral health of children with diabetes mellitus type I compared to healthy controls

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030709

Enrollment

200

Registered

2022-11-11

Start date

2022-06-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 K02.9

Interventions

Group 1: Diabetes type 1 patients, aged 6-18 years (for parameters collected: see primary and secondary endpoint). Group 2: Healthy children of the same age as in arm 1 (for parameters collected: see

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: - Age between 6 and 18 years - Diagnosed diabetes mellitus type I - Fulfillment of ASA I-III classification

Exclusion criteria

Exclusion criteria: no further

Design outcomes

Primary

Measure	Time frame
- Dental findings: All existing and missing teeth should be taken into account and restorations (fillings/crowns) and carious defects visually and tactilely with a dental probe. On the basis of these results, the DMF-T Index will be calculated. The DMF-T index is used internationally to measure caries incidence and prevalence. The teeth that are decayed, extracted (missing) or filled (filled) are counted. The value can assume a maximum value of 28 in the permanent dentition. - Proximal plaque index (API) according to Lange et al. as an indication of the current plaque infestation and short-term oral hygiene. - Papilla bleeding index (PBI) according to Saxer and Mühlemann as an indication of gingival inflammation and thus medium-term oral hygiene. - Periodontal findings: The deepest probing depth per tooth is documented for each tooth present. The periodontal screening index is then also determined from this. - Collection of saliva and plaque samples for subsequent microbiome examinations: The collection of saliva is performedwithin 3 minutes by "spitting" into a sterile container. The collection of plaque is performed from the tooth surface into a sterile container using a sterile dental probe. - Salivary flow rate and salivary buffer capacity testing: Salivary flow rate and salivary buffer capacity are measured using a commercially available kit (KariesScreenTest+P, AUROSAN GmbH, Essen, Germany).	—

Measure

Time frame

- Dental findings: All existing and missing teeth should be taken into account and restorations (fillings/crowns) and carious defects visually and tactilely with a dental probe. On the basis of these results, the DMF-T Index will be calculated. The DMF-T index is used internationally to measure caries incidence and prevalence. The teeth that are decayed, extracted (missing) or filled (filled) are counted. The value can assume a maximum value of 28 in the permanent dentition. - Proximal plaque index (API) according to Lange et al. as an indication of the current plaque infestation and short-term oral hygiene. - Papilla bleeding index (PBI) according to Saxer and Mühlemann as an indication of gingival inflammation and thus medium-term oral hygiene. - Periodontal findings: The deepest probing depth per tooth is documented for each tooth present. The periodontal screening index is then also determined from this. - Collection of saliva and plaque samples for subsequent microbiome examinations: The collection of saliva is performedwithin 3 minutes by "spitting" into a sterile container. The collection of plaque is performed from the tooth surface into a sterile container using a sterile dental probe. - Salivary flow rate and salivary buffer capacity testing: Salivary flow rate and salivary buffer capacity are measured using a commercially available kit (KariesScreenTest+P, AUROSAN GmbH, Essen, Germany).

—

Secondary

Measure	Time frame
Retrospective data: - Age, height and weight - abdominal and hip circumference - HbA1c values over the last 12 months - If glucose pump available: Glucose profile for the last 30 days - Number of nocturnal hypoglycemias in the last 7 days - Time in range in the last 7 days - Type of treatment of nocturnal hypoglycemias - Number of times sugary drinks were taken between 8 p.m. and 8 a.m. - Number of snacks in the last 7 days - Number of dental visits in the last 12 months - Did the dentist provide any special education due to diabetes mellitus?	—

Measure

Time frame

Retrospective data: - Age, height and weight - abdominal and hip circumference - HbA1c values over the last 12 months - If glucose pump available: Glucose profile for the last 30 days - Number of nocturnal hypoglycemias in the last 7 days - Time in range in the last 7 days - Type of treatment of nocturnal hypoglycemias - Number of times sugary drinks were taken between 8 p.m. and 8 a.m. - Number of snacks in the last 7 days - Number of dental visits in the last 12 months - Did the dentist provide any special education due to diabetes mellitus?

—

Countries

Germany

Contacts

Public ContactKonstantin Johannes Scholz

Poliklinik für Zahnerhaltung und Parodontologie, Universitätsklinikum Regensburg

Konstantin.Scholz@ukr.de09419446024

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026