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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07546279
Acronym
OSSIXPERIO
Enrollment
40
Registered
2026-04-22
Start date
2025-05-08
Completion date
2029-05-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Defects, Periodontitis

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

Interventions

DEVICEEMD + 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.

DEVICEEMD + 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Magnitude of PPD (Periodontal Probing Depth) changes12 monthsThe 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

MeasureTime frameDescription
Proportion of pocket closure12 months
Magnitude of CAL (Clinical Attachment Level) changes12 monthsThe 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
Magnitude of REC (Recession) changes12 monthsThe 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
Presence of plaque in the site of intervention, measured dichotomously (Yes / No)12 monthsThe 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
Presence of bleeding in the site of intervention measured dichotomously (Yes / No)12 monthsThe 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
Tooth retention12 monthsThe persistence of the treated tooth, at the follow-up visit, in the mouth. It will be evaluated through clinical examination.
Radiographic bone gain12 monthsMeasured in periapical radiographs, as the difference, in mm, between preoperative bone level and follow-up bone level.
Pain measured through a 0-100 Visual Analogue Scale (VAS) scale for pain7 daysPatients 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026