The effect of treatment for gum disease (periodontitis) on the type and amount of lipids (fats) in the blood and the function of the endothelium, the thin membrane that lines the heart and blood vessels, in patients with type 2 diabetes
| ISRCTN | ISRCTN69139365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69139365 |
- Submission date
- 18/07/2022
- Registration date
- 23/07/2022
- Last edited
- 16/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study is to investigate whether treating gum disease (generalized periodontitis) in patients diagnosed with type 2 diabetes is able to change the level and type of fats (lipid) in the blood, termed the lipid profile, and the function of the endothelium, the thin membrane that lines the heart and blood vessels.
Who can participate?
Patients diagnosed with type 2 diabetes with gum disease (generalized periodontitis)
What does the study involve?
What are the possible benefits and risks of participating?
The possible benefit of participating in the trial is the improvement of lipid profile and endothelial function. The are no risks associated with participation in the trial.
Where is the study run from?
Albanian University (Albania)
When is the study starting and how long is it expected to run for?
January 2018 to March 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Biagio Rapone (Albania)
biagio.rapone@uniba.it
Contact information
Principal Investigator
University of Bari Aldo Moro
Piazza Giulio Cesare 11
Bari
70124
Italy
| Phone | +3477619817 |
|---|---|
| biagio.rapone@uniba.it |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The impact of intensive periodontal treatment on lipid profile and endothelial function in patients with type 2 diabetes: A randomized clinical trial |
| Study objectives | Intensive periodontal therapy improves the serum lipid profile and the endothelial function in patients with type 2 diabetes |
| Ethics approval(s) | Approved 27/03/2018, Albanian University Committee (Albanian Universit, Rruga e Durresit, Tirane I 001, Albania; +355 686086880; e.qorri@albanianuniversity.edu.al), ref: Nr.114 |
| Health condition(s) or problem(s) studied | Improvement of endothelial function and serum lipid profile in patients with type 2 diabetes via periodontal treatment |
| Intervention | Before treatment, patients of both groups received oral hygiene instructions. All study participants underwent Intensive Periodontal Treatment (IPT) or Control Periodontal Treatment (CPT) within 1 month from the baseline visit. The protocol of IPT consisted of a single session of one-stage full-mouth disinfection (OSFM), which implicated, supra- and sub-gingival mechanical debridement scaling and manual root surface and calculus removal of all pockets, under local analgesia, within 24 hours in association with chlorhexidine application to all oropharyngeal niches (chairside and at home for 2 months after treatment). Additionally, periodontal surgery was executed for periodontal pockets >5 mm or residual periodontal pockets. The CPT included supra-gingival mechanical debridement. The root planning was delayed at 6 months, after the completion of the trial. At 3 months, supra- and sub-gingival mechanical debridement scaling was executed for both groups. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Serum lipid profile including levels of: 1. Serum total cholesterol measured by enzyme-linked immunosorbent assays (ELISA) at baseline, 3, and 6 months 2. Serum triglyceride measured by ELISA at baseline, 3, and 6 months 3. Low-density lipoprotein cholesterol measured by ELISA at baseline, 3, and 6 months 4. High-density lipoprotein cholesterol measured by ELISA at baseline, 3, and 6 months 5. Flow-mediated vasodilation (FMD) was assessed non-invasively, using the flow-mediated dilation (FMD) technique at baseline, 3, and 6 months - as an index of endothelium-dependent vasodilation |
| Secondary outcome measures | 1. High-sensitive C-reactive protein measured using a commercially available kit at baseline, 3, and 6 months 2. Periodontal pocket depth measured using the manual periodontal probe at baseline, 3, and 6 months 3. Clinical attachment level measured using the manual periodontal probe at baseline, 3, and 6 months |
| Overall study start date | 02/01/2018 |
| Completion date | 29/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 145 per group |
| Total final enrolment | 290 |
| Key inclusion criteria | 1. Patients diagnosed with type 2 diabetes 2. Generalized periodontitis |
| Key exclusion criteria | 1. Provision of informed consent prior to initiation of any study procedures 2. Declined cognitive function and unable to make informed consent 3. Periodontal treatment within the last 12 months 4. Systemic antibiotic therapy within the last 6 months 5. Pregnancy or breastfeeding 6. Uncontrolled hypertension 7. History of heart disease or stroke which might interfere with systemic antioxidative status 8. Active smokers (>10 cigarettes/daily) were excluded |
| Date of first enrolment | 28/03/2018 |
| Date of final enrolment | 23/05/2018 |
Locations
Countries of recruitment
- Albania
Study participating centre
Tirane
1001
Albania
Sponsor information
University/education
Rruga e Durresit
Tirana
001
Albania
| Phone | +355 686086880 |
|---|---|
| informacioni@albanianuniversity.edu.al | |
| Website | https://albanianuniversity.edu.al |
"ROR" |
https://ror.org/02f8a6404 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/10/2022 | 16/01/2023 | Yes | No |
Editorial Notes
16/01/2023: Publication reference and total final enrollment number added.
22/07/2022: Trial's existence confirmed by Albanian University Committee.
