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

NCT07546279 | Recruiting

• 1 other identifier: OSSIXPERIO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Periodontitis; Bone Defects

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (8)

• Proportion of pocket closure

  12 months

• Magnitude of CAL (Clinical Attachment Level) changes

  12 months

• Magnitude of REC (Recession) changes

  12 months

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

  12 months

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

  12 months

Study Arms (2)

EMD + Collagenated DBBM

ACTIVE COMPARATOR

Device: EMD + collagenated DBBM

EMD + hydroxyapatite collagen matrix

EXPERIMENTAL

Device: EMD + hydroxyapatite collagen matrix

Interventions

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 + Collagenated DBBM

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.

EMD + hydroxyapatite collagen matrix

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: April 22, 2026
• Study Start: May 8, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2025-12

Locations

IT (1)