Rh-PDGF vs EMD for Treatment of Intra-bony Defects

Launched by NOVA SOUTHEASTERN UNIVERSITY · Jun 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a dental condition called intra-bony periodontal defects, which are deep pockets in the gums that can lead to tooth loss if not treated. Patients who have had scaling and root planing—a cleaning procedure for gum disease—will be screened to see if they have these defects. Those who qualify will be randomly assigned to one of two groups: one will receive a treatment that combines a growth factor (called GEM-21) with a bone graft, and the other will receive a different treatment using enamel matrix derivatives (EMD) with a bone graft. Both groups will undergo the same surgical procedure and will be monitored for six months to assess how effective each treatment is.

To be eligible for this trial, participants must be 18 years or older, generally healthy, and available for follow-up visits after six months. They should have specific types of gum defects and a certain level of gum disease, but cannot be pregnant, heavy smokers, or have uncontrolled diabetes, among other criteria. If you join the trial, you can expect to receive either of the two treatments and will have regular check-ups to see how well your gums are healing. This study aims to find the best way to help patients with these kinds of dental issues.

Gender

ALL

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