Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients

Not Applicable

• Conditions: Periodontal Diseases
• Interventions: Procedure: Root Instrumentation; Device: Enamel Matrix Derivative application

• Registration Number: NCT04237662
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04
• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Enamel Matrix Derivative application	Root Instrumentation + Enamel Matrix Derivative Application Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
Test Group	Root Instrumentation	Root Instrumentation + Enamel Matrix Derivative Application Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
Control Group	Root Instrumentation	Root Instrumentation Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
Glycated Hemoglobin (HbA1c)	Measured at Baseline and 3 months after treatment	analyzed through blood sampling. Unit of measure: mmol/mol
Clinical attachment level (CAL)	Measured at Baseline and 3 months after treatment	Changes in CAL, measured orally through clinical examination. Unit of measure: mm
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: %
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
High sensitivity C-Reactive Protein (hsCRP)	Measured at Baseline and 3 months after treatment	analyzed through blood sampling. Unit of measure: mg/L
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
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: %
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.

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy