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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
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
University Hospital of Pisa
Pisa, Italy
RECRUITINGPocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Time frame: Measured at Baseline and 3 months after treatment
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Time frame: Measured at Baseline and 3 months after treatment
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Time frame: Measured at Baseline and 3 months after treatment
Number of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: N
Time frame: Measured at Baseline and 3 months after treatment
Percentage of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: %
Time frame: Measured at Baseline and 3 months after treatment
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Changes, measured orally through clinical examination. Unit of measure: %
Time frame: Measured at Baseline and 3 months after treatment
Full-mouth plaque score (FMPS)
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.
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Time frame: Measured at Baseline and 3 months after treatment
Full-mouth bleeding score (FMBS)
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.
Time frame: Measured at Baseline and 3 months after treatment
Oral Health Index Profile-14 (OHIP-14)
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
Time frame: Measured at Baseline and 3 months after treatment
Oxford Happiness Questionnaire (OHQ)
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.
Time frame: Measured at Baseline and 3 months after treatment
High sensitivity C-Reactive Protein (hsCRP)
analyzed through blood sampling. Unit of measure: mg/L
Time frame: Measured at Baseline and 3 months after treatment
Glycated Hemoglobin (HbA1c)
analyzed through blood sampling. Unit of measure: mmol/mol
Time frame: Measured at Baseline and 3 months after treatment