Periodontal Diseases
Conditions
Brief summary
The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of periodontal healing in diabetic patients.
Detailed description
Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm. Metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.
Interventions
PROCEDURERoot Instrumentation
Instrumentation of the root surface in order to achieve debridement
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Opaque envelopes
Intervention model description
Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with diabetes mellitus type II and currently under treatment; * No previous periodontal treatment in the last 6 months; * Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth); * Ability to understand the study procedures and comply with them through the length of the study.
Exclusion criteria
* Pregnancy and breast feeding; * Need for antibiotic treatment during periodontal therapy; * Chronic infections; * Systemic diseases; * Patients who report current smoking over 20 cigarettes per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket probing depth (PPD) | Measured at Baseline and 3 months after treatment | Changes in PPD, measured orally through clinical examination. Unit of measure: mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recession of the gingival margin (REC) | Measured at Baseline and 3 months after treatment | Changes in REC, measured orally through clinical examination. Unit of measure: mm |
| Number of sites with Pocket probing depth deeper than 5mm | Measured at Baseline and 3 months after treatment | Changes, measured orally through clinical examination. Unit of measure: N |
| Percentage of sites with Pocket probing depth deeper than 5mm | Measured at Baseline and 3 months after treatment | Changes, measured orally through clinical examination. Unit of measure: % |
| Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline | Measured at Baseline and 3 months after treatment | Changes, measured orally through clinical examination. Unit of measure: % |
| Full-mouth plaque score (FMPS) | Measured at Baseline and 3 months after treatment | Changes in Full-mouth plaque score, measuring the amount of dental plaque on the teeth orally through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i.e. plaque absent) to 100% (maximum value: all areas are occupied by plaque). 0% would the ideal value. No sub-scales are included. |
| Clinical attachment level (CAL) | Measured at Baseline and 3 months after treatment | Changes in CAL, measured orally through clinical examination. Unit of measure: mm |
| Oral Health Index Profile-14 (OHIP-14) | Measured at Baseline and 3 months after treatment | Changes in Oral Health Index Profile-14 measured through administration of specific questionnaire . Responses for the questionnaire are made on a Likert-type five-point scale, coded 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), and 4 (very often); with scores ranging from 0-56 and higher scores indicating worse |
| Oxford Happiness Questionnaire (OHQ) | Measured at Baseline and 3 months after treatment | Responses for the questionnaire are made on a Likert scale, coded from strongly disagree = 1 to strongly agree = 6, with the higher scores corresponding to higher levels of happiness. For the 12 negatively worded items, the reverse coding is necessary before calculating the total score, which is a sum of individual item scores. Score range is from 1 as a minimum and 6 as a maximum score. |
| High sensitivity C-Reactive Protein (hsCRP) | Measured at Baseline and 3 months after treatment | analyzed through blood sampling. Unit of measure: mg/L |
| Glycated Hemoglobin (HbA1c) | Measured at Baseline and 3 months after treatment | analyzed through blood sampling. Unit of measure: mmol/mol |
| Full-mouth bleeding score (FMBS) | Measured at Baseline and 3 months after treatment | Changes of Full-mouth bleeding score, measuring the number of gingival areas that bleed after gingival probe passage. It is measured oral through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i. e. gingival inflammation is absent) to 100% (maximum value: all gingival areas are inflamed). 0% would be the ideal value. No sub-scales are included. |
Countries
Italy
Outcome results
None listed