Treatment of gum disease in patients with diabetes mellitus
| ISRCTN | ISRCTN00559156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00559156 |
| Secondary identifying numbers | PE_DiaPD_001 |
- Submission date
- 04/09/2009
- Registration date
- 23/09/2009
- Last edited
- 10/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francesco D'Aiuto
Scientific
Scientific
Periodontology Unit
Division of Clinical Research
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom
Study information
| Study design | Non-randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2003 |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Cases = 44, controls = 49 (total = 93) |
| 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 |
Locations
Countries of recruitment
- England
- Italy
- United Kingdom
Study participating centre
Periodontology Unit
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Sponsor information
University of Perugia (Università degli Studi di Perugia) (Italy)
University/education
University/education
c/o Dr Calabrese Antonio
Dipartimento di Medicina Interna e Scienze Endocrine e Metaboliche
Peuriga
06100
Italy
| Website | http://www.unipg.it/ |
|---|---|
"ROR" |
https://ror.org/00x27da85 |
Funders
Funder type
Hospital/treatment centre
University of Perugia (Università degli Studi di Perugia) (Italy) - Department of Internal Medicine and Endocrinology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2011 | Yes | No |
