Back to resultsEnamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients (PERIOEMD-4)
Primary Purpose
Periodontal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Root Instrumentation
Enamel Matrix Derivative application
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
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.
Sites / Locations
- University Hospital of PisaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Secondary Outcome Measures
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Number of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: N
Percentage of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: %
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Changes, measured orally through clinical examination. Unit of measure: %
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.
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.
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
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.
High sensitivity C-Reactive Protein (hsCRP)
analyzed through blood sampling. Unit of measure: mg/L
Glycated Hemoglobin (HbA1c)
analyzed through blood sampling. Unit of measure: mmol/mol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04237662
Brief Title
Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients
Acronym
PERIOEMD-4
Official Title
The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Opaque envelopes
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Root Instrumentation
Intervention Description
Instrumentation of the root surface in order to achieve debridement
Intervention Type
Device
Intervention Name(s)
Enamel Matrix Derivative application
Intervention Description
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
Primary Outcome Measure Information:
Title
Pocket probing depth (PPD)
Description
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Secondary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Title
Recession of the gingival margin (REC)
Description
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Title
Number of sites with Pocket probing depth deeper than 5mm
Description
Changes, measured orally through clinical examination. Unit of measure: N
Time Frame
Measured at Baseline and 3 months after treatment
Title
Percentage of sites with Pocket probing depth deeper than 5mm
Description
Changes, measured orally through clinical examination. Unit of measure: %
Time Frame
Measured at Baseline and 3 months after treatment
Title
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Description
Changes, measured orally through clinical examination. Unit of measure: %
Time Frame
Measured at Baseline and 3 months after treatment
Title
Full-mouth plaque score (FMPS)
Description
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.
Time Frame
Measured at Baseline and 3 months after treatment
Title
Full-mouth bleeding score (FMBS)
Description
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
Title
Oral Health Index Profile-14 (OHIP-14)
Description
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
Title
Oxford Happiness Questionnaire (OHQ)
Description
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
Title
High sensitivity C-Reactive Protein (hsCRP)
Description
analyzed through blood sampling. Unit of measure: mg/L
Time Frame
Measured at Baseline and 3 months after treatment
Title
Glycated Hemoglobin (HbA1c)
Description
analyzed through blood sampling. Unit of measure: mmol/mol
Time Frame
Measured at Baseline and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Graziani, DDS, PhD
Phone
0039050992939
Email
filippo.graziani@med.unipi.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30663788
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.
Results Reference
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Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients
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