Clinical trial NCT04237662: Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients
Official title: The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pocket probing depth (PPD)
timeFrame: Measured at Baseline and 3 months after treatment
Secondary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Recession of the gingival margin (REC)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Number of sites with Pocket probing depth deeper than 5mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Percentage of sites with Pocket probing depth deeper than 5mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
timeFrame: Measured at Baseline and 3 months after treatment
measure: Full-mouth plaque score (FMPS)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Full-mouth bleeding score (FMBS)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Oral Health Index Profile-14 (OHIP-14)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Oxford Happiness Questionnaire (OHQ)
timeFrame: Measured at Baseline and 3 months after treatment
measure: High sensitivity C-Reactive Protein (hsCRP)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Glycated Hemoglobin (HbA1c)
timeFrame: Measured at Baseline and 3 months after treatment
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
References:
citation: Graziani F, Gennai S, Petrini M, Bettini L, Tonetti M. Enamel matrix derivative stabilizes blood clot and improves clinical healing in deep pockets after flapless periodontal therapy: A Randomized Clinical Trial. J Clin Periodontol. 2019 Feb;46(2):231-240. doi: 10.1111/jcpe.13074.