A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiddharth Shanbhag

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Medical conditions contraindicating surgery

Pregnancy or lactation

Current use of systemic antibiotics

Smoking >10 cigarettes/day

Trial design

Treatments tested in this trial

  • Hydrogel
  • Hydrogel

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Siddharth Shanbhag

Lead sponsor

University of Oslo

Sponsor institution

Universidad Complutense de Madrid

Collaborator