NCT05442034 Rh-PDGF vs EMD for Treatment of Intra-bony Defects
| NCT ID | NCT05442034 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Nova Southeastern University |
| Condition | Intrabony Periodontal Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-01-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Theofilos Koutouzis, DDS, MS
STUDY DIRECTOR
Nova Southeastern University
Frequently Asked Questions
Who can join the NCT05442034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intrabony Periodontal Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05442034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05442034 currently recruiting?
Yes, NCT05442034 is actively recruiting participants. Contact the research team at nm1859@mynsu.nova.edu for enrollment information.
Where is the NCT05442034 trial being conducted?
This trial is being conducted at Davie, United States.
Who is sponsoring the NCT05442034 clinical trial?
NCT05442034 is sponsored by Nova Southeastern University. The principal investigator is Theofilos Koutouzis, DDS, MS at Nova Southeastern University. The trial plans to enroll 36 participants.