Intrabony Periodontal DefectPhase 1/2NCT05442034
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
A Phase 1/2 study testing growth factors to help in regeneration in people with Intrabony Periodontal Defect, run by Nova Southeastern University at 1 site in United States.
Trial summary
Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- growth factors to help in regeneration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Jun 2027
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age is 18 years old and older
- Absence of relevant medical conditions
- Availability for 6-month follow-up
- Subjects who recently have received scaling and root planing due to periodontal disease
- Single-rooted and multi-rooted teeth in either the maxilla or the mandible.
- Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm.
- Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects)
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <20% at surgery
Who cannot join
- Female patients who are pregnant or planning to be pregnant during the period of the study
- Heavy smokers (>10 cigarettes a day)
- Subjects not willing to comply to the study protocol
- Patients with uncontrolled diabetes (HbA1c >7.5)
- Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate)
- Periapical lesion in the tested sites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Davie, Florida, 33314
Arsalan Danesh, DDS, 561-212-6377, ad2900@mynsu.nova.edu
Cristina Garcia Godoy, DDS, 954-262-7388, cgarciag@nova.edu
About this study
Official title: Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.
Read the detailed description
Alveolar bone crest is considered normal when it is found at a distance of 0.4- 1.97mm from the cementoenamel junction (CEJ) of the tooth. Chronic inflammation resulting from periodontal disease (PD) may lead to change in this architecture and formation of osseous defects. The variation in the form of these defects may be influenced by the occlusal stresses that the tooth is subjected to or the original form of the alveolar process in a localized area.
While Glickman chose to classify the osseous defects into "Osseous craters, intra-bony defects, bulbous osseous contours, hemi-septa, inconsistent margins and ledges"; Pritchard classified them as "interproximal craters, inconsistent margins, hemi-septa, furca invasions, intra-bony defects and a combination of these defects". Identifying the type of defect is of utmost importance. Intra-bony defects found in the interproximal areas can be one-wall, two-walls, or three-walls defects, depending on how many walls are remaining. On the other hand, when the inter-radicular bone is lost, its commonly classified as grade I, grade II, or grade III furcation.
Successful regeneration of the intra-bony defects will be accompanied by clinical attachment gain, decreased pocket depth, radiographic bone height gain, and improved periodontal health, to reach this goal, several types of bone grafts, membranes, biologics and/or combinations, have been investigated for potential application and, they proved success over short- and long-term.
Flemming et al. 1998, tested the bone gain following open flap debridement (OFD) versus allogeneic bone graft. The group that received allogenic bone graft had higher bone gain compared to the OFD group at 6 months (2.2mm vs 1.2mm) and 3 years (2.3mm vs 1.1mm) (P <0.05). Comparable results were found when A. Sculean et al 2004, tested CAL gain when enamel matrix proteins (EMD) was used versus OFD; having 1.3mm of CAL gain at 5 years when the latter was used versus 2.9mm when the former was used (p<0.001). Eickholz et al. 2004, tested the use of bioabsorbable membrane for the treatment of intra-bony defects with guided tissue regeneration. Attachment height gain was stable at 12- and 60-months follow up (3.5mm and 2.2mm). In a case series, Kim et al. compared the clinical attachment gain in 12 pairs of intra-bony defects in 12 subjects. One side was randomly assigned to receive GTR with a bioabsorbable membrane (Polyglactin) (control), while the contralateral received non-resorbable membrane (e-PTFE) (test). Both groups yielded significant clinical attachment gain at 6 (C6 and T6) and 60 months (C60 and T60), (C6: 2.6 ± 1.4 mm; C60: 1.6 ± 1.5 mm; T6: 3.0 ± 1.7 mm; T60: 3.0 ± 0.7 mm).
Emdogain is a biologic material that consists of hydrophobic enamel matrix proteins extracted from developing embryogenic enamel of porcine origin. It was first tested on monkeys for ability to regenerate buccal dehiscence defects and resulted in complete regeneration of the defect. It was later used in conjunction with Modified Widman Flap (MWF) and compared to MWF with placebo, for the regeneration of intra-bony defects in human subjects. At 36 months, the EMD group yielded significantly higher bone gain (2.2 mm vs 1.7 mm), respectively.
Platelet derived growth factors (PDGF) is a human serum polypeptide growth factor, it is a potent mitogen for cells of mesenchymal origin (e.g., fibroblasts), it stimulates collagen synthesis, chemotaxis of fibroblasts and production of insulin-like growth factors (IGF). It has been tested both in vitro and in vivo, it has proved potential for promoting soft tissue wound repair, and when used in periodontal defects, it stimulated healing with new bone and cementum formation, and a deposition of a continuous layer of osteoblasts was noticed lining the newly formed bone.
Based on the above evidence, it is now clear that different techniques and biomaterials can be used for periodontal regeneration. It is the purpose of the current study, to investigate the effect of rh-PDGF (test) in its commercial form (GEM21) and enamel matrix derivatives in its commercial form (EMD) (control) in combination with allografts for the treatment of periodontal defects in one-wall and two-walls intra-bony defects in human subjects.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- growth factors to help in regeneration
- Keywords
- Periodontal regeneration, Inta-bony defects, Enamel matrix derivatives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth factors to help in regenerationBiological
regenerative therapy
| Study group | Role | What they receive |
|---|---|---|
| recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft | Experimental | recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration. Receives: Biological: growth factors to help in regeneration |
| Enamel matrix derivatives (EMD) in combination with bone allograft. | Active comparator | Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects. Receives: Biological: growth factors to help in regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Changes
Change in gingival recession and pocket probing depth
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theofilos Koutouzis, DDS, MS, Study director, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442034
- Sponsor's protocol ID
- 2022-217-NSU
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
- ClinicalTrials.gov ID
- NCT05442034
- Acronym / sponsor ID
- 2022-217-NSU
- Conditions
- Intrabony Periodontal Defect
- Keywords
- Periodontal regeneration, Inta-bony defects, Enamel matrix derivatives
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jul 2022 (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.
Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.
Detailed description
Alveolar bone crest is considered normal when it is found at a distance of 0.4- 1.97mm from the cementoenamel junction (CEJ) of the tooth. Chronic inflammation resulting from periodontal disease (PD) may lead to change in this architecture and formation of osseous defects. The variation in the form of these defects may be influenced by the occlusal stresses that the tooth is subjected to or the original form of the alveolar process in a localized area.
While Glickman chose to classify the osseous defects into "Osseous craters, intra-bony defects, bulbous osseous contours, hemi-septa, inconsistent margins and ledges"; Pritchard classified them as "interproximal craters, inconsistent margins, hemi-septa, furca invasions, intra-bony defects and a combination of these defects". Identifying the type of defect is of utmost importance. Intra-bony defects found in the interproximal areas can be one-wall, two-walls, or three-walls defects, depending on how many walls are remaining. On the other hand, when the inter-radicular bone is lost, its commonly classified as grade I, grade II, or grade III furcation.
Successful regeneration of the intra-bony defects will be accompanied by clinical attachment gain, decreased pocket depth, radiographic bone height gain, and improved periodontal health, to reach this goal, several types of bone grafts, membranes, biologics and/or combinations, have been investigated for potential application and, they proved success over short- and long-term.
Flemming et al. 1998, tested the bone gain following open flap debridement (OFD) versus allogeneic bone graft. The group that received allogenic bone graft had higher bone gain compared to the OFD group at 6 months (2.2mm vs 1.2mm) and 3 years (2.3mm vs 1.1mm) (P <0.05). Comparable results were found when A. Sculean et al 2004, tested CAL gain when enamel matrix proteins (EMD) was used versus OFD; having 1.3mm of CAL gain at 5 years when the latter was used versus 2.9mm when the former was used (p<0.001). Eickholz et al. 2004, tested the use of bioabsorbable membrane for the treatment of intra-bony defects with guided tissue regeneration. Attachment height gain was stable at 12- and 60-months follow up (3.5mm and 2.2mm). In a case series, Kim et al. compared the clinical attachment gain in 12 pairs of intra-bony defects in 12 subjects. One side was randomly assigned to receive GTR with a bioabsorbable membrane (Polyglactin) (control), while the contralateral received non-resorbable membrane (e-PTFE) (test). Both groups yielded significant clinical attachment gain at 6 (C6 and T6) and 60 months (C60 and T60), (C6: 2.6 ± 1.4 mm; C60: 1.6 ± 1.5 mm; T6: 3.0 ± 1.7 mm; T60: 3.0 ± 0.7 mm).
Emdogain is a biologic material that consists of hydrophobic enamel matrix proteins extracted from developing embryogenic enamel of porcine origin. It was first tested on monkeys for ability to regenerate buccal dehiscence defects and resulted in complete regeneration of the defect. It was later used in conjunction with Modified Widman Flap (MWF) and compared to MWF with placebo, for the regeneration of intra-bony defects in human subjects. At 36 months, the EMD group yielded significantly higher bone gain (2.2 mm vs 1.7 mm), respectively.
Platelet derived growth factors (PDGF) is a human serum polypeptide growth factor, it is a potent mitogen for cells of mesenchymal origin (e.g., fibroblasts), it stimulates collagen synthesis, chemotaxis of fibroblasts and production of insulin-like growth factors (IGF). It has been tested both in vitro and in vivo, it has proved potential for promoting soft tissue wound repair, and when used in periodontal defects, it stimulated healing with new bone and cementum formation, and a deposition of a continuous layer of osteoblasts was noticed lining the newly formed bone.
Based on the above evidence, it is now clear that different techniques and biomaterials can be used for periodontal regeneration. It is the purpose of the current study, to investigate the effect of rh-PDGF (test) in its commercial form (GEM21) and enamel matrix derivatives in its commercial form (EMD) (control) in combination with allografts for the treatment of periodontal defects in one-wall and two-walls intra-bony defects in human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft.
| Arm | Type | Receives |
|---|---|---|
| recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft | Experimental | Biological: growth factors to help in regenerationrecombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration. |
| Enamel matrix derivatives (EMD) in combination with bone allograft. | Active comparator | Biological: growth factors to help in regenerationEnamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is 18 years old and older
- Absence of relevant medical conditions
- Availability for 6-month follow-up
- Subjects who recently have received scaling and root planing due to periodontal disease
- Single-rooted and multi-rooted teeth in either the maxilla or the mandible.
Key exclusion criteria (6 listed)
- Female patients who are pregnant or planning to be pregnant during the period of the study
- Heavy smokers (>10 cigarettes a day)
- Subjects not willing to comply to the study protocol
- Patients with uncontrolled diabetes (HbA1c >7.5)
- Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate)
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 |
|---|---|---|
| growth factors to help in regenerationregenerative therapy | Biological | Enamel matrix derivatives (EMD) in combination with bone allograft., recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft |
Primary outcome
Clinical Attachment Changes
Time frame: 12 months
Change in gingival recession and pocket probing depth
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Theofilos Koutouzis, DDS, MS study director
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing growth factors to help in regeneration in people with Intrabony Periodontal Defect, run by Nova Southeastern University at 1 site in United States.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Neshatafarin Manouchehri, D.D.S (7342494806, nm1859@mynsu.nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Changes (time frame: 12 months). 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 16 Apr 2026.