Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/09/2009
Date assigned
23/09/2009
Last edited
10/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco D'Aiuto

ORCID ID

Contact details

Periodontology Unit
Division of Clinical Research
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom

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

http://www.unipg.it/

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

  1. 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.

Additional files

Editorial Notes