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NCT Number: NCT07546279

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.

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

Recruiting

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Key information

Conditions

Periodontitis Bone Defects Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

Location status: Recruiting

Location contact

Dr. Sara Zacchetti

CONTACT

[email protected]

+39 0283502227

Stefano Corbella, DDS, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

EMD + collagenated DBBM

Device

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 matrix

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of pocket closure

    Time frame: 12 months

  2. Magnitude of CAL (Clinical Attachment Level) changes

    Time frame: 12 months

    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

  3. Magnitude of REC (Recession) changes

    Time frame: 12 months

    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

  4. Presence of plaque in the site of intervention, measured dichotomously (Yes / No)

    Time frame: 12 months

    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

  5. Presence of bleeding in the site of intervention measured dichotomously (Yes / No)

    Time frame: 12 months

    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

  6. Tooth retention

    Time frame: 12 months

    The persistence of the treated tooth, at the follow-up visit, in the mouth. It will be evaluated through clinical examination.

  7. Radiographic bone gain

    Time frame: 12 months

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

  8. Pain measured through a 0-100 Visual Analogue Scale (VAS) scale for pain

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

2 Title The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.

Acronym: OSSIXPERIO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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