Periodontal DiseasesPERIOEMD-2NCT03544931
Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy
A study testing Root Instrumentation and EMD 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 acute-phase responses in healthy 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 EMD 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 Dec 2015to 1 Jun 2018
- 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
- Good health
- No previous periodontal treatment
- 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.
About this study
Official title: The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless 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 acute-phase responses in healthy 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.
Systemic inflammation 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, EMD 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
EMD ApplicationDevice
Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
| Study group | Role | What they receive |
|---|---|---|
| Root Instrumentation + EMD Application | Experimental | 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: EMD Application |
| Root Instrumentation | Active comparator | 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.
Change of C Reactive Protein (CRP) at 24 hour
CRP analyzed though blood sampling. Unit of measure: mg/L
Measured: Collected at Baseline and 24 hours in order to calculate the changes
Secondary outcomes (20)
Glucose
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Baseline, 24 hours and 3 months after treatment
Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Collected at Baseline, 24 hours and 3 months after treatment
LDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Collected at Baseline, 24 hours and 3 months after treatment
HDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Collected at Baseline, 24 hours and 3 months after treatment
Triglyceride
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Collected at Baseline, 24 hours and 3 months after treatment
Fibrinogen
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Collected at Baseline, 24 hours and 3 months after treatment
D-Dimer
analyzed though blood sampling. Unit of measure: mg/L
Measured: Collected at Baseline, 24 hours and 3 months after treatment
Cystatin C
analyzed though blood sampling. Unit of measure: mg/L
Measured: Collected at Baseline, 24 hours 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 orally 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 the ideal value. No sub-scales are included.
Measured: Measured at Baseline and 3 months after treatment
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
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 3mm
Changes, measured orally through clinical examination. Unit of measure: N
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 3mm
Changes, measured orally through clinical examination. Unit of measure: %
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
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Changes , measured orally through clinical examination. Unit of measure: N
Measured: Measured at Baseline and 3 months after treatment
C Reactive Protein (CRP) at 3 months
CRP analyzed though blood sampling. Unit of measure: mg/L
Measured: Collected 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 posted4 Jun 2018
- Study start1 Dec 2015
- Primary completion1 Jan 2018
- Study completion1 Jun 2018
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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544931
- Sponsor's protocol ID
- 3649/15B
- Acronym
- PERIOEMD-2
- Status last verified
- Jul 2018
- First submitted
- 30 Apr 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03544931
- Acronym / sponsor ID
- PERIOEMD-2 / 3649/15B
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 4 Jun 2018 (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 acute-phase responses in healthy 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.
Systemic inflammation 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
| Arm | Type | Receives |
|---|---|---|
| Root Instrumentation + EMD Application | Experimental | Procedure: Root Instrumentation, Device: EMD ApplicationPeriodontal 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 | Active comparator | Procedure: Root InstrumentationPeriodontal 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)
- Good health
- No previous periodontal treatment
- 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 | Root Instrumentation, Root Instrumentation + EMD Application |
| EMD ApplicationApplication of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm | Device | Root Instrumentation + EMD Application |
Primary outcome
Change of C Reactive Protein (CRP) at 24 hour
Time frame: Collected at Baseline and 24 hours in order to calculate the changes
CRP analyzed though blood sampling. Unit of measure: mg/L
20 secondary outcomes
Glucose
Time frame: Baseline, 24 hours and 3 months after treatment
Cholesterol
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
LDL Cholesterol
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
HDL Cholesterol
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
Triglyceride
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
Fibrinogen
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
D-Dimer
Time frame: Collected at Baseline, 24 hours and 3 months after treatment
Cystatin C
Time frame: Collected at Baseline, 24 hours 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
Pocket probing depth (PPD)
Time frame: Measured at Baseline and 3 months after treatment
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 3mm
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 3mm
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
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Time frame: Measured at Baseline and 3 months after treatment
C Reactive Protein (CRP) at 3 months
Time frame: Collected 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: 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: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 EMD 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: finished, as of the sponsor's last update on 6 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of C Reactive Protein (CRP) at 24 hour (time frame: Collected at Baseline and 24 hours in order to calculate the changes). 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 NCT03544931, 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 6 Jul 2018.