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Periodontal treatment for improving glycaemic control in diabetic patients

Periodontal treatment for improving glycaemic control in diabetic patients: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15334496
Enrollment
150
Registered
2009-04-30
Start date
2009-05-01
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Diabetes mellitus, periodontal disease Nutritional, Metabolic, Endocrine Unspecified diabetes mellitus

Interventions

Periodontal treatment will include non-surgical scaling and root planing, systemic antibiotherapy, oral health instructions and antiseptic prescription. It will be performed within 10 days after inclu

Sponsors

University Hospital of Toulouse (CHU de Toulouse) (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female, aged >= 18 year old 2. Diabetes mellitus (type I or II), diagnosed since at least one year 3. HbA1c levels comprised between 7.0 and 9.5% 4. No change in diabetic medication 3 months before inclusion 5. Periodontal disease (at least one site on at least 4 teeth with Probing Pocket Depth >= 4 mm AND Clinical Attachment Loss >= 3 mm) 6. At least 6 remaining teeth 7. Subject able to understand and willing to provide written informed consent in French 8. Subject affiliated to the security system

Exclusion criteria

Exclusion criteria: 1. Receiving antibiotherapy or chronic steroid therapy 2. Presence of significant renal disease, as indicated by creatinine clearance less than 60 ml/min 3. Have another medical condition likely to cause hospitalisation within 4 months 4. Presence of serious or unstable infectious disease, hepatic disease, phenylcetonuria 5. Subject at risk of endocarditis 6. Pacemaker 7. Antithrombotic treatment 8. History of allergy to amoxicillin and clindamycin 9. Pregnant, lactating, or plans to become pregnant during the study 10. Participation in another study with an investigational compound

Design outcomes

Primary

MeasureTime frame
Difference between 3-month and baseline HbA1c levels.

Secondary

MeasureTime frame
Difference between 3-month and baseline values of the following: 1. Fructosamin levels 2. Quality of life (SF-36® Health Survey) 3. Adverse clinical outcome event 4. Periodontal Inflamed Surface Area (PISA)

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026