PeriodontitisNCT06991998
Evaluation of Clinical and Radiological Outcomes Following the Treatment of Periodontal Intraosseous Defects Using Autogenous Tooth-derived Graft or Autogenous Bone Graft With Enamel Matrix Derivatives. A 12-month Randomized Controlled Clinical Trial.
A study testing Autogenous bone graft with enamel matrix derivative and Autogenous tooth-derived graft with enamel matrix derivative in people with Periodontitis, run by Semmelweis University at 1 site in Hungary.
Trial summary
This clinical study aims to evaluate and compare two different materials used to treat bone defects caused by periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting structures of teeth, including the bone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Autogenous bone graft with enamel matrix derivative and Autogenous tooth-derived graft with enamel matrix derivative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 24 Oct 2024to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic periodontitis
- Both male and female participants
- Patients with less than 25% plaque score (FMPS: Full Mouth Plaque Score) and bleeding index (FMBS: Full Mouth Bleeding Score) after non-surgical periodontal therapy
- Good patient compliance (maintains good oral hygiene and is willing to participate in 12-month follow-up)
- Patients who understand the nature of the study after receiving written information and provide signed informed consent
- Patients older than 18 years
Show all 9Show fewer
- Non-self-contained intraosseous defects (wide (radiological angle > 37°) and/or one- or two-wall defects) in the maxilla or mandible with a baseline probing depth of ≥ 6 mm
- The defect has an intraosseous component of ≥ 3 mm
- The patient has at least one tooth that needs extraction for any reason
Who cannot join
- Patients with systemic conditions such as:
- Alcoholism Drug addiction Known HIV, HBV, or HCV infection Patients undergoing chemotherapy or radiation therapy Current or past head and neck radiation therapy Untreated insulin-dependent diabetes mellitus Clinically significant osteoporosis or other systemic conditions affecting bone metabolism Clinically significant cardiovascular conditions such as decompensated heart failure, hemodynamically significant heart valve insufficiency, or myocardial infarction within the last 3 months Clinically significant coagulation disorders
- Previous or current systemic corticosteroid therapy (within 2 months of inclusion): more than 5 mg of prednisolone per day
- Previous or current bisphosphonate therapy lasting at least 30 days within the past 12 months
- Long-term antibiotic or anti-inflammatory therapy within the past 4 months
- Pregnant or breastfeeding women
Show all 9Show fewer
- Smoking (>5 cigarettes/day)
- Furcation involvement
- Wisdom teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Semmelweis University, Department of Periodontology
Budapest, Budapest, 1088
About this study
This clinical study aims to evaluate and compare two different materials used to treat bone defects caused by periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting structures of teeth, including the bone. One of the most severe forms of this damage is called an "intraosseous defect," where the bone around a tooth is lost in a vertical pattern.
To repair these defects, dentists often perform a regenerative surgery using grafting materials and biologically active substances to stimulate tissue regrowth. The current standard includes using autogenous bone grafts (ABG)-bone taken from another part of the patient's mouth-combined with enamel matrix derivatives (EMD), a protein-based gel that promotes healing. However, this approach requires creating a second surgical site to harvest the bone, which can increase patient discomfort and healing time.
Read more
Recently, a promising alternative has emerged: autogenous tooth-derived bone grafts (ATB). In this technique, a patient's own extracted tooth is processed into a grafting material and used to fill the bone defect. This method has the advantage of using a material that would otherwise be discarded and avoids the need for an additional surgical area. Early studies suggest that tooth-derived grafts may have similar regenerative potential to traditional bone grafts because of their comparable structure and the presence of natural growth factors.
The purpose of this randomized controlled trial is to determine whether ATB combined with EMD can achieve the same or better clinical and radiological outcomes as ABG combined with EMD in the treatment of periodontal intraosseous defects.
A total of 60 adult patients with chronic periodontitis will be enrolled. Each participant must have at least one advanced bone defect around a tooth and one other tooth that needs to be extracted for unrelated reasons. Patients will be randomly assigned to receive either ATB or ABG, both with EMD, during a single surgical procedure.
The study includes multiple follow-up visits over the course of one year, and at 12 months, a re-entry surgery will allow the research team to directly observe bone healing inside the defect.
The findings could support a more patient-friendly and equally effective alternative to traditional bone grafting in periodontal regenerative surgery.
Read the detailed description
This randomized controlled clinical trial investigates the regenerative efficacy of autogenous tooth-derived graft material (ATB) in comparison with autogenous bone graft (ABG) in the treatment of periodontal intraosseous defects. Enamel matrix derivative (EMD) is applied to all defects in both treatment groups as part of the regenerative procedure, and a standardized, minimally invasive flap approach is used for defect access.
The regenerative management of intrabony periodontal defects often involves the application of biologically active materials in conjunction with particulate grafts, especially in non-contained defects. While autogenous bone is widely regarded as the gold standard due to its osteogenic and osteoinductive properties, its harvesting requires an additional surgical site, leading to increased morbidity and treatment time. Autogenous tooth-derived biomaterial (ATB) represents an innovative alternative with promising biological properties. The dentin graft contains a variety of growth factors and has demonstrated regenerative potential in preclinical and clinical studies.
In this study, eligible defects are treated surgically using the Single Flap Approach (SFA), either buccally or palatally/lingually, depending on defect location. After local anesthesia, a full-thickness mucoperiosteal flap is elevated using sulcular incisions extended to adjacent teeth, while preserving the interdental papilla. The defect area is thoroughly debrided and root surfaces are conditioned with 24% EDTA gel (PrefGel®, Straumann) for 2 minutes, followed by thorough rinsing with sterile saline. Then, enamel matrix derivative (Emdogain®, Straumann) is applied onto the root surface according to the manufacturer's instructions.
In the test group, autogenous tooth-derived graft is prepared using the Bonmaker® system (Korean Dental Solution). The patient's extracted tooth is cleaned and processed into particulate form. A decalcification and sterilization process is carried out in a closed system, ensuring the preservation of bioactive molecules including TGF-β, BMPs, and IGFs. In the control group, autogenous bone is harvested from intraoral donor sites such as the mandibular ramus or maxillary tuberosity using a manual bone scraper. The graft material is applied into the defect without the use of a barrier membrane.
Flaps are repositioned and sutured using 6-0 monofilament non-resorbable sutures, employing horizontal mattress and interrupted techniques to ensure tension-free primary closure. Postoperative care includes systemic antibiotics (amoxicillin/clavulanic acid or clindamycin in case of allergy) for 7 days, analgesics as needed, and 0.2% chlorhexidine mouthrinse twice daily for 14 days. Sutures are removed after 10 to 14 days. Supportive periodontal therapy is provided monthly for the first 3 months, then every 2 to 3 months until the final follow-up.
Radiographic evaluation is standardized using the long cone paralleling technique and individualized silicone bite registrations. Radiographs are obtained preoperatively and at 6 and 12 months following the surgical intervention.
A re-entry procedure is performed 12 months postoperatively to allow for direct clinical evaluation of bone fill. Custom-made acrylic templates are fabricated to standardize probing during the initial surgery and the re-entry.
The objective of the study is to determine whether autogenous tooth-derived biomaterial can achieve comparable regenerative outcomes to autogenous bone graft, while offering the advantage of reduced patient morbidity and surgical complexity.
- Conditions
- Periodontitis
- Being tested
- Autogenous bone graft with enamel matrix derivative, Autogenous tooth-derived graft with enamel matrix derivative
- Keywords
- periodontal regeneration, periodontitis, graft, intrabony defect, tooth-derived graft, enamel matrix derivatives, autogenous bone graft
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous bone graft with enamel matrix derivativeProcedure or surgery
Participants receive periodontal regenerative surgery using autogenous bone graft harvested from a secondary intraoral donor site (mandibular ramus or maxillary tuberosity) with a bone scraper. The bone graft is placed into the debrided intraosseous defect, and enamel matrix derivative (EMD) is applied to the root surface. Surgical access is performed using a single flap approach (SFA), and primary closure is achieved with microsurgical sutures.
Autogenous tooth-derived graft with enamel matrix derivativeProcedure or surgery
Participants receive periodontal regenerative surgery using autogenous tooth-derived particulate graft processed from an extracted tooth using a standardized protocol (Bonmaker® device and chemical decontamination), combined with enamel matrix derivative (EMD) applied to the root surface. The surgical site is accessed using a single flap approach (SFA), and graft material is placed into the non-self-contained intraosseous defect after debridement. Primary closure is achieved with microsurgical sutures.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Bone Graft + EMD | Active comparator | Not described Receives: Procedure: Autogenous bone graft with enamel matrix derivative |
| Autogenous Tooth-Derived Graft + EMD | Experimental | Not described Receives: Procedure: Autogenous tooth-derived graft with enamel matrix derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Measured: At baseline and at 6 months and 12 months following the surgical intervention
Secondary outcomes (5)
Bone fill in the intraosseous defects
Measured: During the surgical intervention and after 12 months during the re-entry
Postoperative pain level
Using Visual Analog Scale (VAS)
Measured: 7 days from the surgical intervention
Clinical attachment gain (∆CAL)
Measured: At baseline and at 6 months and 12 months following the surgical intervention
Changes in gingival recession (∆GR)
Measured: At baseline and at 6 months and 12 months following the surgical intervention
Radiological bone fill
Standardized intraoral radiograph
Measured: At baseline and at 6 months and 12 months following the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start24 Oct 2024
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Forgó Kristóf, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991998
- Sponsor's protocol ID
- 200/2024.
- Status last verified
- Apr 2026
- First submitted
- 19 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiological Outcomes Following the Treatment of Periodontal Intraosseous Defects Using Autogenous Tooth-derived Graft or Autogenous Bone Graft With Enamel Matrix Derivatives. A 12-month Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06991998
- Acronym / sponsor ID
- 200/2024.
- Conditions
- Periodontitis
- Keywords
- periodontal regeneration, periodontitis, graft, intrabony defect, tooth-derived graft, enamel matrix derivatives, autogenous bone graft
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to evaluate and compare two different materials used to treat bone defects caused by periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting structures of teeth, including the bone. One of the most severe forms of this damage is called an "intraosseous defect," where the bone around a tooth is lost in a vertical pattern.
To repair these defects, dentists often perform a regenerative surgery using grafting materials and biologically active substances to stimulate tissue regrowth. The current standard includes using autogenous bone grafts (ABG)-bone taken from another part of the patient's mouth-combined with enamel matrix derivatives (EMD), a protein-based gel that promotes healing. However, this approach requires creating a second surgical site to harvest the bone, which can increase patient discomfort and healing time.
Recently, a promising alternative has emerged: autogenous tooth-derived bone grafts (ATB). In this technique, a patient's own extracted tooth is processed into a grafting material and used to fill the bone defect. This method has the advantage of using a material that would otherwise be discarded and avoids the need for an additional surgical area. Early studies suggest that tooth-derived grafts may have similar regenerative potential to traditional bone grafts because of their comparable structure and the presence of natural growth factors.
The purpose of this randomized controlled trial is to determine whether ATB combined with EMD can achieve the same or better clinical and radiological outcomes as ABG combined with EMD in the treatment of periodontal intraosseous defects.
A total of 60 adult patients with chronic periodontitis will be enrolled. Each participant must have at least one advanced bone defect around a tooth and one other tooth that needs to be extracted for unrelated reasons. Patients will be randomly assigned to receive either ATB or ABG, both with EMD, during a single surgical procedure.
The study includes multiple follow-up visits over the course of one year, and at 12 months, a re-entry surgery will allow the research team to directly observe bone healing inside the defect.
The findings could support a more patient-friendly and equally effective alternative to traditional bone grafting in periodontal regenerative surgery.
Detailed description
This randomized controlled clinical trial investigates the regenerative efficacy of autogenous tooth-derived graft material (ATB) in comparison with autogenous bone graft (ABG) in the treatment of periodontal intraosseous defects. Enamel matrix derivative (EMD) is applied to all defects in both treatment groups as part of the regenerative procedure, and a standardized, minimally invasive flap approach is used for defect access.
The regenerative management of intrabony periodontal defects often involves the application of biologically active materials in conjunction with particulate grafts, especially in non-contained defects. While autogenous bone is widely regarded as the gold standard due to its osteogenic and osteoinductive properties, its harvesting requires an additional surgical site, leading to increased morbidity and treatment time. Autogenous tooth-derived biomaterial (ATB) represents an innovative alternative with promising biological properties. The dentin graft contains a variety of growth factors and has demonstrated regenerative potential in preclinical and clinical studies.
In this study, eligible defects are treated surgically using the Single Flap Approach (SFA), either buccally or palatally/lingually, depending on defect location. After local anesthesia, a full-thickness mucoperiosteal flap is elevated using sulcular incisions extended to adjacent teeth, while preserving the interdental papilla. The defect area is thoroughly debrided and root surfaces are conditioned with 24% EDTA gel (PrefGel®, Straumann) for 2 minutes, followed by thorough rinsing with sterile saline. Then, enamel matrix derivative (Emdogain®, Straumann) is applied onto the root surface according to the manufacturer's instructions.
In the test group, autogenous tooth-derived graft is prepared using the Bonmaker® system (Korean Dental Solution). The patient's extracted tooth is cleaned and processed into particulate form. A decalcification and sterilization process is carried out in a closed system, ensuring the preservation of bioactive molecules including TGF-β, BMPs, and IGFs. In the control group, autogenous bone is harvested from intraoral donor sites such as the mandibular ramus or maxillary tuberosity using a manual bone scraper. The graft material is applied into the defect without the use of a barrier membrane.
Flaps are repositioned and sutured using 6-0 monofilament non-resorbable sutures, employing horizontal mattress and interrupted techniques to ensure tension-free primary closure. Postoperative care includes systemic antibiotics (amoxicillin/clavulanic acid or clindamycin in case of allergy) for 7 days, analgesics as needed, and 0.2% chlorhexidine mouthrinse twice daily for 14 days. Sutures are removed after 10 to 14 days. Supportive periodontal therapy is provided monthly for the first 3 months, then every 2 to 3 months until the final follow-up.
Radiographic evaluation is standardized using the long cone paralleling technique and individualized silicone bite registrations. Radiographs are obtained preoperatively and at 6 and 12 months following the surgical intervention.
A re-entry procedure is performed 12 months postoperatively to allow for direct clinical evaluation of bone fill. Custom-made acrylic templates are fabricated to standardize probing during the initial surgery and the re-entry.
The objective of the study is to determine whether autogenous tooth-derived biomaterial can achieve comparable regenerative outcomes to autogenous bone graft, while offering the advantage of reduced patient morbidity and surgical complexity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous Bone Graft + EMD | Active comparator | Procedure: Autogenous bone graft with enamel matrix derivative |
| Autogenous Tooth-Derived Graft + EMD | Experimental | Procedure: Autogenous tooth-derived graft with enamel matrix derivative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with chronic periodontitis
- Both male and female participants
- Patients with less than 25% plaque score (FMPS: Full Mouth Plaque Score) and bleeding index (FMBS: Full Mouth Bleeding Score) after non-surgical periodontal therapy
- Good patient compliance (maintains good oral hygiene and is willing to participate in 12-month follow-up)
- Patients who understand the nature of the study after receiving written information and provide signed informed consent
Key exclusion criteria (9 listed)
- Patients with systemic conditions such as:
- Alcoholism Drug addiction Known HIV, HBV, or HCV infection Patients undergoing chemotherapy or radiation therapy Current or past head and neck radiation therapy Untreated insulin-dependent diabetes mellitus Clinically significant osteoporosis or other systemic conditions affecting bone metabolism Clinically significant cardiovascular conditions such as decompensated heart failure, hemodynamically significant heart valve insufficiency, or myocardial infarction within the last 3 months Clinically significant coagulation disorders
- Previous or current systemic corticosteroid therapy (within 2 months of inclusion): more than 5 mg of prednisolone per day
- Previous or current bisphosphonate therapy lasting at least 30 days within the past 12 months
- Long-term antibiotic or anti-inflammatory therapy within the past 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenous bone graft with enamel matrix derivativeParticipants receive periodontal regenerative surgery using autogenous bone graft harvested from a secondary intraoral donor site (mandibular ramus or maxillary tuberosity) with a bone scraper. The bone graft is placed into the debrided intraosseous defect, and enamel matrix derivative (EMD) is applied to the root surface. Surgical access is performed using a single flap approach (SFA), and primary closure is achieved with microsurgical sutures. | Procedure or surgery | Autogenous Bone Graft + EMD |
| Autogenous tooth-derived graft with enamel matrix derivativeParticipants receive periodontal regenerative surgery using autogenous tooth-derived particulate graft processed from an extracted tooth using a standardized protocol (Bonmaker® device and chemical decontamination), combined with enamel matrix derivative (EMD) applied to the root surface. The surgical site is accessed using a single flap approach (SFA), and graft material is placed into the non-self-contained intraosseous defect after debridement. Primary closure is achieved with microsurgical sutures. | Procedure or surgery | Autogenous Tooth-Derived Graft + EMD |
Primary outcome
Probing pocket depth (PPD)
Time frame: At baseline and at 6 months and 12 months following the surgical intervention
5 secondary outcomes
Bone fill in the intraosseous defects
Time frame: During the surgical intervention and after 12 months during the re-entry
Postoperative pain level
Time frame: 7 days from the surgical intervention
Clinical attachment gain (∆CAL)
Time frame: At baseline and at 6 months and 12 months following the surgical intervention
Changes in gingival recession (∆GR)
Time frame: At baseline and at 6 months and 12 months following the surgical intervention
Radiological bone fill
Time frame: At baseline and at 6 months and 12 months following the surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous bone graft with enamel matrix derivative and Autogenous tooth-derived graft with enamel matrix derivative in people with Periodontitis, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (PPD) (time frame: At baseline and at 6 months and 12 months following the surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.