Gum disease repair: which bone graft works best?
NCT ID NCT07546279
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two different bone graft materials—one from cow bone and one synthetic—combined with a special enamel protein to repair deep gum and bone defects caused by periodontitis. Forty adults with at least one deep gum pocket (6 mm or more) and a bone defect will receive microsurgery to place the graft. The main goal is to see which material reduces pocket depth more after 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enamel matrix derivative (EMD) plus either bovine bone graft (BioOss Collagen) or a synthetic hydroxyapatite collagen sponge (Ossix Bone)
- What this could lead to
- If successful, this could show which bone graft material works better alongside EMD to repair gum and bone damage from periodontitis, potentially improving treatment outcomes.
- What could go wrong
- This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The study compares two materials but does not include a placebo group, making it harder to know if either is truly better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Ospedale Galeazzi-Sant'Ambrogio
RECRUITINGMilan, Italy
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