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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hydrogel
Biological/VaccineA novel cross-linked HA hydrogel incorporating proline-rich peptides (PeriHeal, Corticalis AS, Oslo, Norway) has been developed to enhance periodontal wound healing and regeneration.
Hydrogel
Biological/VaccineHyaluronic acid is currently used in periodontal regenerative surgery as a hydrogel mixture of cross-linked (1.6%) and natural (0.2%) HA of bacterial origin, marketed as hyaDENT BG (Regedent AG, Zurich, Switzerland)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Peptide hydrogelExperimental treatment 1 intervention
Group B: Hyaluronic acid hygrodelActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
CAL change
Changes in Clinical Attachment Level (CAL) of the treated teeth
Time frame
6 and 12 months after periodontal regenerative surgerySecondary outcomes
1
MBL change
Changes in radiographic Marginal Bone Level (MBL)
Time frame
6 and 12 months after regenerative periodontal surgery2
Gingival Healing Index (GHI)
GHI is used to assess the postsurgery conditions of the interdental papilla based on severity of wound dehiscence: score 3: no wound dehiscence and complete flap closure, score 2: minor wound dehiscence with loss of interdental soft tissue limited to the papillary tip; score 1: major wound dehiscence with incomplete flap closure.
Time frame
7 and 14 days after periodontal regenerative surgery3
Oral health related quality of life
Oral health related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) instrument which assesses quality of life based on 14 questions under the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The scale ranges from 0 to 14 with a higher score indicating a worse outcome.
Time frame
6 and 12 months after regenerative surgery4
Proteomic analysis of gingival crevicular fluid (GCF)
Proteomic analysis of GCF from the treated teeth using liquid chromatography mass spectrometry (LC-MS) which semi-quantitatively analyses the total number and type (names and IDs) of proteins present in GCF obtained from the test and control sites.
Time frame
7, 14 and 30 days after regenerative surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Siddharth Shanbhag
Lead sponsor
University of Oslo
Sponsor institution
Universidad Complutense de Madrid
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: