Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients

Periodontal Diseases Clinical Trial

— PERIOEMD-4  

Official title:

The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237662
• Other study ID #: 3649-2019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2020
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• Root Instrumentation
Instrumentation of the root surface in order to achieve debridement

Device:
• Enamel Matrix Derivative application
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket probing depth (PPD)	Changes in PPD, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Secondary	Clinical attachment level (CAL)	Changes in CAL, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Secondary	Recession of the gingival margin (REC)	Changes in REC, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Secondary	Number of sites with Pocket probing depth deeper than 5mm	Changes, measured orally through clinical examination. Unit of measure: N	Measured at Baseline and 3 months after treatment
Secondary	Percentage of sites with Pocket probing depth deeper than 5mm	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
Secondary	Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
Secondary	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.	Measured at Baseline and 3 months after treatment
Secondary	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.	Measured at Baseline and 3 months after treatment
Secondary	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	Measured at Baseline and 3 months after treatment
Secondary	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.	Measured at Baseline and 3 months after treatment
Secondary	High sensitivity C-Reactive Protein (hsCRP)	analyzed through blood sampling. Unit of measure: mg/L	Measured at Baseline and 3 months after treatment
Secondary	Glycated Hemoglobin (HbA1c)	analyzed through blood sampling. Unit of measure: mmol/mol	Measured at Baseline and 3 months after treatment