PeriodontitisOSSIXPERIONCT07546279
The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.
A study testing EMD + collagenated DBBM and EMD + hydroxyapatite collagen matrix in people with Periodontitis and Bone Defects, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The main aim will be to evaluate the difference in PD changes at 12-month follow-up, measured from the gingival margin to the base of the pocket, comparing periodontal regeneration using two different bone substitutes, that is bovine derived xenograft granules (BioOss® Collagen) and one resorbable sponge-like… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis, Bone Defects
- What is being tested?
- EMD + collagenated DBBM and EMD + hydroxyapatite collagen matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women over or equal to the age of 18 years
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2)
- Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular / buccal or the lingual support bone wall (PPD lingual or vestibular / buccal <= 3.5 mm ) of the affected teeth.
- Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility
- Patients who can 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.
Who cannot join
- FMPS% > 15% at the time of recruitment
- FMBS% > 15% at the time of recruitment
- Treatment with anticoagulant drugs (INR above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
- patients with history of alcohol, narcotics, or drug abuse
Show all 26Show fewer
- 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 any of the products used in the study
- 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 (5 cigarettes and more per day)
- Other uncontrolled systemic diseases
- disorders or treatments that compromise wound healing
- chronic high dose steroid therapy
- bone metabolic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan
Dr. Sara Zacchetti, +39 0283502227, sara.zacchetti@grupposandonato.it
Stefano Corbella, DDS, PhD
About this study
Official title: 2 Title The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.
The main aim will be to evaluate the difference in PD changes at 12-month follow-up, measured from the gingival margin to the base of the pocket, comparing periodontal regeneration using two different bone substitutes, that is bovine derived xenograft granules (BioOss® Collagen) and one resorbable sponge-like hydroxyapatite collagen matrix (OssixTM Bone), in adjunct with EMD after microsurgical flap elevation.
Inclusion criteria I. Men and women over or equal to the age of 18 years II. Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2) III. Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular / buccal or the lingual support bone wall (PPD lingual or vestibular / buccal <= 3.5 mm ) of the affected teeth.
Read more
IV. Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility V. Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules VI. Patients who had provided written informed consent to participate in the study prior to any study procedure.
Exclusion criteria I. FMPS% > 15% at the time of recruitment II. FMBS% > 15% at the time of recruitment III. Treatment with anticoagulant drugs (INR above 2,5) IV. Treatment with intravenous bisphosphonates V. Treatment with anticonvulsants drugs VI. patients with history of alcohol, narcotics, or drug abuse VII. Patients receiving radiotherapy, chemotherapy, or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years VIII. Patients through at any time received radiotherapy to the head and neck region will be excluded anyway IX. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia X. Degenerative diseases XI. Osteoradionecrosis XII. Renal failure XIII. Organ transplant recipients XIV. HIV positive (self-declaration) XV. Malignant diseases XVI. Diseases that compromise the immune system XVII. Unbalanced diabetes. (HbA1c above 7.2 assessed by self-declaration) XVIII. Psychotic diseases XIX. Hypersensitivity or specific contraindications to one of the components of any of the products used in the study XX. Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery XXI. Site where a history of failed periodontal regenerative procedure in the last two years XXII. Heavy Smokers (5 cigarettes and more per day) XXIII. other uncontrolled systemic diseases XXIV. disorders or treatments that compromise wound healing XXV. chronic high dose steroid therapy XXVI. bone metabolic diseases
- Conditions
- Periodontitis, Bone Defects
- Being tested
- EMD + collagenated DBBM, EMD + hydroxyapatite collagen matrix
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD + collagenated DBBMDevice
EMD will be mixed with collagenated DBBM (BioOss® Collagen); the bone substitute will then be placed into the intrabony defect. Non-resorbable sutures will be used (single internal mattress modified or other type of sutures). (P. Cortellini \& Tonetti, 2015) The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication. A questionnaire for PROMS will be given to the subject.
EMD + hydroxyapatite collagen matrixDevice
EMD will be applied on the radicular surface. The hydroxyapatite collagen matrix (Ossix) will be cut to the required size to fit the intrabony defect, hydrated with EMD, and placed in the defect and there moistened with the blood of the patient. Non-resorbable sutures will be used (single internal mattress modified or other type of sutures). (P. Cortellini \& Tonetti, 2015) The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication. A questionnaire for PROMS will be given to the subject.
| Study group | Role | What they receive |
|---|---|---|
| EMD + Collagenated DBBM | Active comparator | Not described Receives: Device: EMD + collagenated DBBM |
| EMD + hydroxyapatite collagen matrix | Experimental | Not described Receives: Device: EMD + hydroxyapatite collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of PPD (Periodontal Probing Depth) changes
The change of periodontal probing depth (measured, in the site of intervention, in mm, as the distance between the gingival margin and the most apical extent of the periodontal pocket, by using a periodontal probe) calculated as the difference between baseline value and follow-up value
Measured: 12 months
Secondary outcomes (8)
Proportion of pocket closure
Measured: 12 months
Magnitude of CAL (Clinical Attachment Level) changes
The change of clinical attachment level (measured, in the site of intervention, in mm, as the distance between the cemento-enamel junction and the most apical extent of the periodontal pocket, by using a periodontal probe) calculated as the difference between baseline value and follow-up value
Measured: 12 months
Magnitude of REC (Recession) changes
The change of gingival recession value (measured, in the site of intervention, in mm, as the distance between the cemento-enamel junction and the gingival margin, by using a periodontal probe) calculated as the difference between baseline value and follow-up value
Measured: 12 months
Presence of plaque in the site of intervention, measured dichotomously (Yes / No)
The presence of plaque will be evaluated by clinical examination and through the use of a periodontal probe. The score will be 1, corresponding to the presence of visible dental plaque in that specific site, or 0, corresponding to absence of visible dental plaque
Measured: 12 months
Presence of bleeding in the site of intervention measured dichotomously (Yes / No)
The presence of plaque will be evaluated by clinical examination and through the use of a periodontal probe. The score will be 1, corresponding to the presence of bleeding in that specific site, or 0, corresponding to absence of bleeding
Measured: 12 months
Tooth retention
The persistence of the treated tooth, at the follow-up visit, in the mouth. It will be evaluated through clinical examination.
Measured: 12 months
Radiographic bone gain
Measured in periapical radiographs, as the difference, in mm, between preoperative bone level and follow-up bone level.
Measured: 12 months
Pain measured through a 0-100 Visual Analogue Scale (VAS) scale for pain
Patients will be asked to mark on a 10 cm 0-100 visual scale the level of perceived pain, knowing that 0 (left) means no pain and 100 (right) means unbearable pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start8 May 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546279
- Sponsor's protocol ID
- OSSIXPERIO
- Acronym
- OSSIXPERIO
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 Title The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.
- ClinicalTrials.gov ID
- NCT07546279
- Acronym / sponsor ID
- OSSIXPERIO / OSSIXPERIO
- Conditions
- Periodontitis, Bone Defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Apr 2026 (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 main aim will be to evaluate the difference in PD changes at 12-month follow-up, measured from the gingival margin to the base of the pocket, comparing periodontal regeneration using two different bone substitutes, that is bovine derived xenograft granules (BioOss® Collagen) and one resorbable sponge-like hydroxyapatite collagen matrix (OssixTM Bone), in adjunct with EMD after microsurgical flap elevation.
Inclusion criteria I. Men and women over or equal to the age of 18 years II. Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2) III. Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular / buccal or the lingual support bone wall (PPD lingual or vestibular / buccal <= 3.5 mm ) of the affected teeth.
IV. Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility V. Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules VI. Patients who had provided written informed consent to participate in the study prior to any study procedure.
Exclusion criteria I. FMPS% > 15% at the time of recruitment II. FMBS% > 15% at the time of recruitment III. Treatment with anticoagulant drugs (INR above 2,5) IV. Treatment with intravenous bisphosphonates V. Treatment with anticonvulsants drugs VI. patients with history of alcohol, narcotics, or drug abuse VII. Patients receiving radiotherapy, chemotherapy, or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years VIII. Patients through at any time received radiotherapy to the head and neck region will be excluded anyway IX. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia X. Degenerative diseases XI. Osteoradionecrosis XII. Renal failure XIII. Organ transplant recipients XIV. HIV positive (self-declaration) XV. Malignant diseases XVI. Diseases that compromise the immune system XVII. Unbalanced diabetes. (HbA1c above 7.2 assessed by self-declaration) XVIII. Psychotic diseases XIX. Hypersensitivity or specific contraindications to one of the components of any of the products used in the study XX. Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery XXI. Site where a history of failed periodontal regenerative procedure in the last two years XXII. Heavy Smokers (5 cigarettes and more per day) XXIII. other uncontrolled systemic diseases XXIV. disorders or treatments that compromise wound healing XXV. chronic high dose steroid therapy XXVI. bone metabolic diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMD + Collagenated DBBM | Active comparator | Device: EMD + collagenated DBBM |
| EMD + hydroxyapatite collagen matrix | Experimental | Device: EMD + hydroxyapatite collagen matrix |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women over or equal to the age of 18 years
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2)
- Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular / buccal or the lingual support bone wall (PPD lingual or vestibular / buccal <= 3.5 mm ) of the affected teeth.
- Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility
- Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules
Key exclusion criteria (26 listed)
- FMPS% > 15% at the time of recruitment
- FMBS% > 15% at the time of recruitment
- Treatment with anticoagulant drugs (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 |
|---|---|---|
| EMD + collagenated DBBMEMD will be mixed with collagenated DBBM (BioOss® Collagen); the bone substitute will then be placed into the intrabony defect. Non-resorbable sutures will be used (single internal mattress modified or other type of sutures). (P. Cortellini \& Tonetti, 2015) The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication. A questionnaire for PROMS will be given to the subject. | Device | EMD + Collagenated DBBM |
| EMD + hydroxyapatite collagen matrixEMD will be applied on the radicular surface. The hydroxyapatite collagen matrix (Ossix) will be cut to the required size to fit the intrabony defect, hydrated with EMD, and placed in the defect and there moistened with the blood of the patient. Non-resorbable sutures will be used (single internal mattress modified or other type of sutures). (P. Cortellini \& Tonetti, 2015) The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication. A questionnaire for PROMS will be given to the subject. | Device | EMD + hydroxyapatite collagen matrix |
Primary outcome
Magnitude of PPD (Periodontal Probing Depth) changes
Time frame: 12 months
The change of periodontal probing depth (measured, in the site of intervention, in mm, as the distance between the gingival margin and the most apical extent of the periodontal pocket, by using a periodontal probe) calculated as the difference between baseline value and follow-up value
8 secondary outcomes
Proportion of pocket closure
Time frame: 12 months
Magnitude of CAL (Clinical Attachment Level) changes
Time frame: 12 months
Magnitude of REC (Recession) changes
Time frame: 12 months
Presence of plaque in the site of intervention, measured dichotomously (Yes / No)
Time frame: 12 months
Presence of bleeding in the site of intervention measured dichotomously (Yes / No)
Time frame: 12 months
Tooth retention
Time frame: 12 months
Radiographic bone gain
Time frame: 12 months
Pain measured through a 0-100 Visual Analogue Scale (VAS) scale for pain
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMD + collagenated DBBM and EMD + hydroxyapatite collagen matrix in people with Periodontitis and Bone Defects, 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 6 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Magnitude of PPD (Periodontal Probing Depth) changes (time frame: 12 months). 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 22 Apr 2026.