Intrabony Periodontal DefectNCT05354037
Flapless Approach for the Treatment of Intrabony Defects
A study testing Enamel matrix derivative application for treatment of intrabony defects in people with Intrabony Periodontal Defect, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Enamel matrix derivative application for treatment of intrabony defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2021to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over or equal to the age of 18 years
- Patients who are able to understand the requirements of the study and are willing and able to comply with its instructions and schedules
- Patients who had provided written informed consent to participate in the study prior to any study procedure
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (American Society of Anesthesiologists ASA 1 or ASA-2)
- Patients having one or more self-contained (3-wall or 2-3 walls) intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation.
Who cannot join
- FMPS% > 15%
- FMBS% > 15%
- Treatment with anticoagulant drugs (International Normalized Ratio (INR) above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
- untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements
Show all 23Show fewer
- Patients with history of alcohol, narcotics or drug abuse
- Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years
- Patients through at any time received radiotherapy to the head and neck region will be excluded anyway
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Degenerative diseases
- Osteoradionecrosis
- Renal failure
- Organ transplant recipients
- HIV positive (self-declaration)
- Malignant diseases
- Diseases that compromise the immune system
- Unbalanced diabetes (HbA1c above 7.2 assessed by self-declaration)
- Psychotic diseases
- Hypersensitivity or specific contraindications to one of the components of EMD
- Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery
- Site where a history of failed periodontal regenerative procedure in the last two years
- Heavy Smokers (10 cigarettes and more per day).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Galeazzi
Milan, 20161
Stefano Corbella, DDS, PhD, 02 50319950, stefano.corbella@unimi.it
Stefano Corbella, DDS, PhD
About this study
Official title: Flapless Approach for the Treatment of Self-contained Intrabony Defects: a Randomized Controlled Clinical Trial
The use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anatomy. The main aim of this study will be to evaluate the difference in Clinical Attachment Level (CAL) between baseline and 1-year follow-up, comparing flapless periodontal regeneration using EMD versus the use of EMD after microsurgical flap elevation (Modified-Minimally Invasive Surgical Technique (M-MIST) / Single-flap approach).
Read the detailed description
The secondary aims of the study are:
- to evaluate the comparative effectiveness of the proposed treatment evaluating patient-centered outcomes.
- to evaluate, after one year from the treatment, the comparative effectiveness evaluating clinical parameters: (I) Probing Depth (PD) measured from the gingival margin to the base of the pocket; (II) Recession (REC) measured as the distance between the CEJ and the gingival margin; (III) Presence of plaque in the site of intervention, measured dichotomously (Yes / No) (Plaque index (PI)); (IV) Presence of bleeding in the site of intervention, measured dichotomously (Yes / No) (Bleeding Index (BI)); (V) Full-mouth Bleeding Score (FMBS%); (VI) Full-mouth Plaque Score (FMPS%); (VII) the proportion of treated sites for each group that presented PD <= 3 mm. ; (VIII) tooth retention
- to evaluate the comparative effectiveness evaluating radiographic parameters: (I) The distance between the Cemento-Enamel Junction (CEJ) and the bottom of the defect (CEJ-A) (II) the distance between the projection of the bone crest to the root surface and the bottom of the defect (representing the intrabony portion of the defect (III) C-A), and the distance between the bone crest and the root surface (representing the maximum width of the defect, C-B) were measured.
Control group: A buccal flap extending to the surfaces of the adjacent teeth will be elevated leading the interdental papilla in position following the M-MIST approach. After degranulation of the defect EMD will be applied following the standard procedure (after preparing root surface with Ethylenediamine tetraacetic acid (EDTA) 22% for two minutes). Non-resorbable 6/0 sutures will be used. The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication.
Test group: The debridement of the pocket will be performed without the elevation of the flap, using ultrasonic tips, air polishing devices and curettes as standard procedure. After that, EMD will be applied and the same procedures as control group will be carried out. Non-resorbable 6/0 sutures will be used in the site of surgical intervention to close coronally the pocket.
At 7 days, suture removal, collection of questionnaires and clinical evaluation will be performed.
Follow-up visits will be carried out at 3, 6, 12, 18 and 24 months.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Enamel matrix derivative application for treatment of intrabony defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel matrix derivative application for treatment of intrabony defectsProcedure or surgery
EMD application will be associated to M-MIST approach in control group and flapless approach in test group.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | EMD + M-MIST approach Receives: Procedure: Enamel matrix derivative application for treatment of intrabony defects |
| Group B | Experimental | EMD with flapless approach Receives: Procedure: Enamel matrix derivative application for treatment of intrabony defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in CAL between baseline and 1-year follow-up
The difference between CAL values at baseline and after 1 year; CAL is defined as the distance between CEJ and the most apical extent of the pocket / sulcus
Measured: 1 year
Secondary outcomes (8)
Difference in PD between baseline and 1-year follow-up
The difference between PD values at baseline and after 1 year; PD is defined as the distance between the gingival margin and the most apical extent of the pocket / sulcus
Measured: 1 year
Difference in REC between baseline and 1-year follow-up
The difference between REC values at baseline and after 1 year; REC is defined as the distance between the CEJ and the gingival margin
Measured: 1 year
Difference in PI between baseline and 1-year follow-up
The difference between PI values at baseline and after 1 year; PI value is 1 if we can detect the presence of plaque or 0 if not
Measured: 1 year
Difference in BI between baseline and 1-year follow-up
The difference between BI values at baseline and after 1 year; BI value is 1 if we can detect the presence of bleeding or 0 if not
Measured: 1 year
Difference in FMBS% between baseline and 1-year follow-up
The difference between FMBS% values at baseline and after 1 year; FMBS% is calculated as the percentage of sites in the whole mouth presenting bleeding
Measured: 1 year
Difference in FMPS% between baseline and 1-year follow-up
The difference between FMPS% values at baseline and after 1 year; FMPS% is calculated as the percentage of sites in the whole mouth presenting plaque
Measured: 1 year
Proportion of treated sites for each group that presented PD <= 3 mm
The number of sites in the whole mouth with PD equal or less than 3 mm
Measured: 1 year
Tooth retention
The presence of tooth in position without any sign / symptom of acute inflammation (abscess, periodical periodontitis)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start13 May 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Corbella, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354037
- Sponsor's protocol ID
- FLPERIO
- Status last verified
- Apr 2022
- First submitted
- 29 Sep 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flapless Approach for the Treatment of Self-contained Intrabony Defects: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05354037
- Acronym / sponsor ID
- FLPERIO
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 29 Apr 2022 (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 use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anatomy. The main aim of this study will be to evaluate the difference in Clinical Attachment Level (CAL) between baseline and 1-year follow-up, comparing flapless periodontal regeneration using EMD versus the use of EMD after microsurgical flap elevation (Modified-Minimally Invasive Surgical Technique (M-MIST) / Single-flap approach).
Detailed description
The secondary aims of the study are:
- to evaluate the comparative effectiveness of the proposed treatment evaluating patient-centered outcomes.
- to evaluate, after one year from the treatment, the comparative effectiveness evaluating clinical parameters: (I) Probing Depth (PD) measured from the gingival margin to the base of the pocket; (II) Recession (REC) measured as the distance between the CEJ and the gingival margin; (III) Presence of plaque in the site of intervention, measured dichotomously (Yes / No) (Plaque index (PI)); (IV) Presence of bleeding in the site of intervention, measured dichotomously (Yes / No) (Bleeding Index (BI)); (V) Full-mouth Bleeding Score (FMBS%); (VI) Full-mouth Plaque Score (FMPS%); (VII) the proportion of treated sites for each group that presented PD <= 3 mm. ; (VIII) tooth retention
- to evaluate the comparative effectiveness evaluating radiographic parameters: (I) The distance between the Cemento-Enamel Junction (CEJ) and the bottom of the defect (CEJ-A) (II) the distance between the projection of the bone crest to the root surface and the bottom of the defect (representing the intrabony portion of the defect (III) C-A), and the distance between the bone crest and the root surface (representing the maximum width of the defect, C-B) were measured.
Control group: A buccal flap extending to the surfaces of the adjacent teeth will be elevated leading the interdental papilla in position following the M-MIST approach. After degranulation of the defect EMD will be applied following the standard procedure (after preparing root surface with Ethylenediamine tetraacetic acid (EDTA) 22% for two minutes). Non-resorbable 6/0 sutures will be used. The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication.
Test group: The debridement of the pocket will be performed without the elevation of the flap, using ultrasonic tips, air polishing devices and curettes as standard procedure. After that, EMD will be applied and the same procedures as control group will be carried out. Non-resorbable 6/0 sutures will be used in the site of surgical intervention to close coronally the pocket.
At 7 days, suture removal, collection of questionnaires and clinical evaluation will be performed.
Follow-up visits will be carried out at 3, 6, 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Enamel matrix derivative application for treatment of intrabony defectsEMD + M-MIST approach |
| Group B | Experimental | Procedure: Enamel matrix derivative application for treatment of intrabony defectsEMD with flapless approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over or equal to the age of 18 years
- Patients who are able to understand the requirements of the study and are willing and able to comply with its instructions and schedules
- Patients who had provided written informed consent to participate in the study prior to any study procedure
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (American Society of Anesthesiologists ASA 1 or ASA-2)
- Patients having one or more self-contained (3-wall or 2-3 walls) intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation.
Key exclusion criteria (23 listed)
- FMPS% > 15%
- FMBS% > 15%
- Treatment with anticoagulant drugs (International Normalized Ratio (INR) above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
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 |
|---|---|---|
| Enamel matrix derivative application for treatment of intrabony defectsEMD application will be associated to M-MIST approach in control group and flapless approach in test group. | Procedure or surgery | Group A, Group B |
Primary outcome
Difference in CAL between baseline and 1-year follow-up
Time frame: 1 year
The difference between CAL values at baseline and after 1 year; CAL is defined as the distance between CEJ and the most apical extent of the pocket / sulcus
8 secondary outcomes
Difference in PD between baseline and 1-year follow-up
Time frame: 1 year
Difference in REC between baseline and 1-year follow-up
Time frame: 1 year
Difference in PI between baseline and 1-year follow-up
Time frame: 1 year
Difference in BI between baseline and 1-year follow-up
Time frame: 1 year
Difference in FMBS% between baseline and 1-year follow-up
Time frame: 1 year
Difference in FMPS% between baseline and 1-year follow-up
Time frame: 1 year
Proportion of treated sites for each group that presented PD <= 3 mm
Time frame: 1 year
Tooth retention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- 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.
Stefano Corbella principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel matrix derivative application for treatment of intrabony defects in people with Intrabony Periodontal Defect, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 5 inclusion and 23 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 29 Apr 2022. 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?
Contact Stefano Corbella, DDS, PhD (02 50319950, stefano.corbella@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in CAL between baseline and 1-year follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.