Rh-PDGF vs EMD for Treatment of Intra-bony Defects (NCT05442034) | Clinical Trial Compass
RecruitingPhase 1/2
Rh-PDGF vs EMD for Treatment of Intra-bony Defects
United States36 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.