Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Comparing two treatments for intra-bony periodontal defects

Official title: Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects

Run by Nova Southeastern University · NCT05442034 · Data updated 2026-11-12

This study is testing whether a new treatment using growth factors works better than a standard treatment for helping adults with deep gum pockets heal and regain healthy gum tissue.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment36 (estimated)
SponsorNova Southeastern University
Academic / other
Locations1 site (Davie, Florida)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedApril 16, 2026
Trial IDNCT05442034 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with specific intra-bony defects and a history of periodontal disease.

Probably not a fit

Patients with uncontrolled diabetes, heavy smokers, or those on certain medications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of recombinant human platelet-derived growth factor (GEM-21) versus enamel matrix derivatives (EMD) in treating intra-bony periodontal defects. Patients aged 18 and older who have persistent deep probing depths after scaling and root planing will be randomly assigned to receive one of the two treatments combined with an allogenic bone graft. The study will follow participants for six months to assess clinical attachment gain, pocket depth reduction, and radiographic bone height improvement. The trial seeks to enhance understanding of periodontal regeneration techniques and their outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with intra-bony periodontal defects, enhancing their periodontal health.

How similar studies have gone: Previous studies have shown promising results with similar regenerative approaches, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Nova Southeastern University
    Davie, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.