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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milan

    Dr. Sara Zacchetti, +39 0283502227, sara.zacchetti@grupposandonato.it

    Stefano Corbella, DDS, PhD

    Recruiting

Other trials in Italy

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

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 groups in NCT07546279
Study groupRoleWhat they receive
EMD + Collagenated DBBMActive comparatorNot described
Receives: Device: EMD + collagenated DBBM
EMD + hydroxyapatite collagen matrixExperimentalNot described
Receives: Device: EMD + hydroxyapatite collagen matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Proportion of pocket closure

    Measured: 12 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Radiographic bone gain

    Measured in periapical radiographs, as the difference, in mm, between preoperative bone level and follow-up bone level.

    Measured: 12 months

  8. 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.

  1. First posted22 Apr 2026
  2. Study start8 May 2025
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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)
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

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.

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