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Compares treatment options for Intrabony Periodontal Defect
Official title Rh-PDGF vs EMD for Treatment of Intra-bony Defects
ClinicalTrials.gov ID: NCT05442034
What this study is testing
What is growth factors to help in regeneration?
growth factors to help in regeneration is an investigational medicine, being studied as a potential treatment for intrabony periodontal defect.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age is 18 years old and older
- Absence of relevant medical conditions
- Availability for 6-month follow-up
- people 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.
You likely can't join if
- Female patients who are pregnant or planning to be pregnant during the period of the study
- Heavy smokers (\>10 cigarettes a day)
- people 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
See the full eligibility criteria
- Age is 18 years old and older
- Absence of relevant medical conditions
- Availability for 6-month follow-up
- people 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
- Female patients who are pregnant or planning to be pregnant during the period of the study
- Heavy smokers (\>10 cigarettes a day)
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Davie, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davie, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.