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

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.

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 Overview

• Status: Recruiting
• Conditions: Periodontitis; Bone Defects
• Intervention / Treatment: Device: EMD + collagenated DBBM; Device: EMD + hydroxyapatite collagen matrix

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Ospedale Galeazzi-Sant'Ambrogio
    • Principal Investigator: Stefano Corbella, DDS, PhD
    • Contact: Dr. Sara Zacchetti; Phone Number: +39 0283502227; Email: sara.zacchetti@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EMD + Collagenated DBBM	Device: EMD + collagenated DBBM; 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.
Experimental: EMD + hydroxyapatite collagen matrix	Device: EMD + hydroxyapatite collagen matrix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of pocket closure		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	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	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	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	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.	12 months
Radiographic bone gain	Measured in periapical radiographs, as the difference, in mm, between preoperative bone level and follow-up bone level.	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.	7 days

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: OSSIXPERIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No