Treatment of gum disease in patients with diabetes mellitus

ISRCTN	ISRCTN00559156
DOI	https://doi.org/10.1186/ISRCTN00559156
Protocol serial number	PE_DiaPD_001
Sponsor	University of Perugia (Università degli Studi di Perugia) (Italy)
Funder	University of Perugia (Università degli Studi di Perugia) (Italy) - Department of Internal Medicine and Endocrinology

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Francesco D'Aiuto
Scientific

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

Primary study design	Interventional
Study design	Non-randomised controlled clinical trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Treatment of periodontitis and metabolic control of patients with diabetes mellitus: a controlled clinical trial
Study acronym	TeDiPe
Study objectives	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(s)	University of Medicine of Perugia Academic Board approved on the 26th November 2002 (ref: 1211)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Changes in HbA1c after 8 months of therapy between cases and controls.
Key secondary outcome measure(s)	Changes in periodontal parameters after therapy between cases and controls, recorded at baseline, 4 and 8 months after periodontal therapy.
Completion date	01/09/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	74
Key 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)
Key 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
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2005

Periodontology Unit

London
WC1X 8LD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes