Periodontal DiseasesPERIOEMD-4NCT04237662
Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients
A study testing Root Instrumentation and Enamel Matrix Derivative application in people with Periodontal Diseases, run by University of Pisa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Root Instrumentation and Enamel Matrix Derivative application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Pisa
Pisa, 56121
Filippo Graziani, DDS, PhD, 0039050992939, filippo.graziani@med.unipi.it
About this study
Official title: The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- Root Instrumentation, Enamel Matrix Derivative application
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root InstrumentationProcedure or surgery
Instrumentation of the root surface in order to achieve debridement
Enamel Matrix Derivative applicationDevice
Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | 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. Receives: Procedure: Root Instrumentation; Device: Enamel Matrix Derivative application |
| Control Group | Active comparator | 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. Receives: Procedure: Root Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and 3 months after treatment
Secondary outcomes (11)
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Measured: 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
Measured: 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
Measured: 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: %
Measured: 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: %
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Measured at Baseline and 3 months after treatment
High sensitivity C-Reactive Protein (hsCRP)
analyzed through blood sampling. Unit of measure: mg/L
Measured: Measured at Baseline and 3 months after treatment
Glycated Hemoglobin (HbA1c)
analyzed through blood sampling. Unit of measure: mmol/mol
Measured: Measured at Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237662
- Sponsor's protocol ID
- 3649-2019
- Acronym
- PERIOEMD-4
- Status last verified
- Nov 2020
- First submitted
- 17 Jan 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30663788
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT04237662
- Acronym / sponsor ID
- PERIOEMD-4 / 3649-2019
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Root Instrumentation, Device: Enamel Matrix Derivative applicationRoot 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 | Active comparator | Procedure: Root InstrumentationRoot 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root InstrumentationInstrumentation of the root surface in order to achieve debridement | Procedure or surgery | Control Group, Test Group |
| Enamel Matrix Derivative applicationEnamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths | Device | Test Group |
Primary outcome
Pocket probing depth (PPD)
Time frame: Measured at Baseline and 3 months after treatment
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
11 secondary outcomes
Clinical attachment level (CAL)
Time frame: Measured at Baseline and 3 months after treatment
Recession of the gingival margin (REC)
Time frame: Measured at Baseline and 3 months after treatment
Number of sites with Pocket probing depth deeper than 5mm
Time frame: Measured at Baseline and 3 months after treatment
Percentage of sites with Pocket probing depth deeper than 5mm
Time frame: Measured at Baseline and 3 months after treatment
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Time frame: Measured at Baseline and 3 months after treatment
Full-mouth plaque score (FMPS)
Time frame: Measured at Baseline and 3 months after treatment
Full-mouth bleeding score (FMBS)
Time frame: Measured at Baseline and 3 months after treatment
Oral Health Index Profile-14 (OHIP-14)
Time frame: Measured at Baseline and 3 months after treatment
Oxford Happiness Questionnaire (OHQ)
Time frame: Measured at Baseline and 3 months after treatment
High sensitivity C-Reactive Protein (hsCRP)
Time frame: Measured at Baseline and 3 months after treatment
Glycated Hemoglobin (HbA1c)
Time frame: Measured at Baseline and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 30663788Graziani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root Instrumentation and Enamel Matrix Derivative application in people with Periodontal Diseases, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket probing depth (PPD) (time frame: Measured at Baseline and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.