Periodontal DiseasesPERIOEMD-1NCT03590093
Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy
A study testing Periodontal surgery 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 surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Periodontal surgery and EMD application
- Type of treatment
- Injection or infusion, 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 Nov 2013to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good health
- No previous periodontal surgical treatment
- Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)
- Ability to understand the study procedures and comply with them through the length of the study
Who cannot join
- Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)
- The need for antibiotic therapy to undergo periodontal therapy
- Chronic infections
- Systemic diseases
- Patients who report current smoking over 20 cigarettes per day or pipe or cigar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy
The aim of this study is to compare surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.
- Conditions
- Periodontal Diseases
- Being tested
- Periodontal surgery, 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.
Periodontal surgeryProcedure or surgery
Also called Open Flap Debridement
After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.
EMD applicationProcedure or surgery
Also called Amelogenins application
Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Surgery with EMD | Experimental | A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability. Receives: Procedure: Periodontal surgery; Procedure: EMD application |
| Periodontal Surgery | Active comparator | A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability. Receives: Procedure: Periodontal surgery |
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 (12)
Glucose
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Triglycerides
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
HDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
LDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Fibrinogen
analyzed though blood sampling. Unit of measure: mg/dL
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
D-Dimer
analyzed though blood sampling. Unit of measure: mg/L
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Cystatin C
analyzed though blood sampling. Unit of measure: mg/L
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
C Reactive Protein (CRP)
CRP analyzed though blood sampling. Unit of measure: mg/L
Measured: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Clinical attachment level (CAL) at deepest site
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and 6 months after treatment
Pocket probing depth (PPD) at deepest site
Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and 6 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 6 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 posted18 Jul 2018
- Study start1 Nov 2013
- Primary completion1 Dec 2017
- 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
- Double blind
- Who is masked
- 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
- NCT03590093
- Sponsor's protocol ID
- 3649/13A
- Acronym
- PERIOEMD-1
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12.
PubMed 32163634
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy
- ClinicalTrials.gov ID
- NCT03590093
- Acronym / sponsor ID
- PERIOEMD-1 / 3649/13A
- 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 Nov 2013 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 18 Jul 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 surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal Surgery with EMD | Experimental | Procedure: Periodontal surgery, Procedure: EMD applicationA surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability. |
| Periodontal Surgery | Active comparator | Procedure: Periodontal surgeryA surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good health
- No previous periodontal surgical treatment
- Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)
- Ability to understand the study procedures and comply with them through the length of the study
Key exclusion criteria (5 listed)
- Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)
- The need for antibiotic therapy to undergo periodontal therapy
- Chronic infections
- Systemic diseases
- Patients who report current smoking over 20 cigarettes per day or pipe or cigar
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 |
|---|---|---|
| Periodontal surgeryAlso: Open Flap DebridementAfter local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed. | Procedure or surgery | Periodontal Surgery, Periodontal Surgery with EMD |
| EMD applicationAlso: Amelogenins applicationApplication of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface | Procedure or surgery | Periodontal Surgery with EMD |
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
12 secondary outcomes
Glucose
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Cholesterol
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Triglycerides
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
HDL Cholesterol
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
LDL Cholesterol
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Fibrinogen
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
D-Dimer
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Cystatin C
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
C Reactive Protein (CRP)
Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Clinical attachment level (CAL) at deepest site
Time frame: Measured at Baseline and 6 months after treatment
Pocket probing depth (PPD) at deepest site
Time frame: Measured at Baseline and 6 months after treatment
Recession of the gingival margin (REC)
Time frame: Measured at Baseline and 6 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 18 Jul 2018.
- Derived from this study: PubMed 32163634Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12.
- 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 Periodontal surgery 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 18 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 NCT03590093, 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 18 Jul 2018.