A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients
Starting soon · Phase 1/Phase 2
Conditions studied: Periodontal Disease, Intrabony Periodontal Defects
In brief
The goal of this clinical trial is to learn if a novel peptide-rich hydrogel works to achieve periodontal regeneration in adults. It will also learn about the safety of the hydrogel. The main questions it aims to answer are: * Does the novel peptide hydrogel achieve periodontal regeneration to a similar degree as another currently used therapy (hyaluronic acid)? * What medical problems, if any, do participants have when receiving the novel hydrogel treatment? Researchers will compare the novel peptide hydrogel to another commonly used hydrogel (hyaluronic acid) to see if the peptide hydrogel works to treat periodontal bone defects. Participants will: * Receive the novel hydorgel or hyaluronic acid when they undergo periodontal regenerative surgery * Visit the clinic at regular intervals for 1 year after the surgery for follow ups
Key facts
- Study ID
- NCT07581613
- Run by
- Siddharth Shanbhag
- People needed
- 40
- Starts
- 2026-11-01
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults >18 years with periodontitis (Stage III or IV)
- Systemically healthy (ASA I or II)
- Non-smokers or smoking <10 cigarettes/day
- Having undergone steps 1 (risk factor control, oral hygiene improvement including interdental hygiene) and 2 (subgingival instrumentation and biofilm control) of systematic periodontal therapy
- Indication for step 3 periodontal therapy, i.e., sites with residual/persistent pockets (PPD >5 mm and BoP or PPD >6 mm) around single- or multi-rooted teeth with mobility <grade II at re-evaluation 8-12 weeks after non-surgical instrumentation (Step 2). Further site-specific criteria include at least one site with a radiographic infrabony defect (2- or 3-walled) with a >3 mm intrabony component, not associated with an open furcation, indicated for regenerative surgery
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20% before surgery
You may not qualify if…
- Medical conditions contraindicating surgery
- Pregnancy or lactation
- Current use of systemic antibiotics
- Smoking >10 cigarettes/day
- FMPS or FMBS >20%
- Mobility grade II or greater
- Acute oral infections, active endo-perio lesions or active carious lesions on teeth associated with bone defects
Where it is running
- Faculty of Dentistry, University of Oslo — Oslo, Norway
- Faculty of Dentistry, University Complutense of Madrid — Madrid, Spain
Full record on ClinicalTrials.gov
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