Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PE_DiaPD_001
Study information
Scientific title
Treatment of periodontitis and metabolic control of patients with diabetes mellitus: a controlled clinical trial
Acronym
TeDiPe
Study hypothesis
To ascertain the impact of periodontal therapy on basic measures of glycaemic control in a population of type 1 and 2 diabetes suffering from mild to moderate periodontitis.
Ethics approval
University of Medicine of Perugia Academic Board approved on the 26th November 2002 (ref: 1211)
Study design
Non-randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus (DM), periodontitis (PD)
Intervention
Intervention group:
1. Oral hygiene instructions and general explanations about PD
2. Intensive periodontal therapy, consisting of:
2.1. Extraction of compromised teeth
2.2. Scaling and root planning of all diseased sites within 24 hours using both ultrasonic and hand instruments
3. Four re-call appointments (at 1, 2, 4 and 8 months respectively)
Control group individuals received a course of standard scaling and polishing.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Changes in HbA1c after 8 months of therapy between cases and controls.
Secondary outcome measures
Changes in periodontal parameters after therapy between cases and controls, recorded at baseline, 4 and 8 months after periodontal therapy.
Overall trial start date
01/09/2003
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 35 to 70 years, either sex
2. Type 1 and 2 diabetes at the department of Endocrinology of Perugia Hospital
3. Presenting with mild to moderate periodontitis (defined as at least six sites in the mouth exhibited probing depths equal or greater than 4 mm; in each patient, bone loss was confirmed by an radiographic assessment)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Cases = 44, controls = 49 (total = 93)
Participant exclusion criteria
1. Presenting with signs of acute infections
2. Uncontrolled diabetes complications
3. Infectious diseases such as hepatitis or human immunodeficiency virus (HIV) infection
4. Patients requiring antibiotic prophylaxis before dental procedures
5. Patients who received a course of systemic antibiotic or periodontal therapy within the preceding 3 months
Recruitment start date
01/09/2003
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Periodontology Unit
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
University of Perugia (Università degli Studi di Perugia) (Italy)
Sponsor details
c/o Dr Calabrese Antonio
Dipartimento di Medicina Interna e Scienze Endocrine e Metaboliche
Peuriga
06100
Italy
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University of Perugia (Università degli Studi di Perugia) (Italy) - Department of Internal Medicine and Endocrinology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21757386
Publication citations
-
Results
Calabrese N, D'Aiuto F, Calabrese A, Patel K, Calabrese G, Massi-Benedetti M, Effects of periodontal therapy on glucose management in people with diabetes mellitus., Diabetes Metab., 2011, 37, 5, 456-459, doi: 10.1016/j.diabet.2011.05.004.