Clinical trial NCT06522438: Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
Official title: Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Wound Heal
Periodontal Pocket
Periodontal Inflammation
Periodontal Attachment Loss
Keywords: Hyaluronic Acid
Octenidine
Biomarkers
Non-surgical periodontal treatment
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.

The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.

The study will consist of 7- 8 visits.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 and above
* Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.
* Periodontitis stage III/IV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm
* Willing to sign informed consent and comply with study procedures

Exclusion Criteria:

* Know hypersensitivity and/or allergy to any of the product's component (as per user leaflet)
* Self-reported pregnancy or lactation
* Smoking (current or in past 5 years), including e-cigarettes/vaping
* Medical history including diabetes mellitus or other serious medical/ psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation
* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or/and systemic antibiotic therapy during the 3 months preceding the baseline evaluation
* In chronic treatment with anti-inflammatory (including corticosteroids), anticoagulants/antiplatelets (including aspirin), immunosuppressants or other medication that can severely impact wound healing
* History of alcohol or drug abuse
* Subgingival professional mechanical plaque removal (excluding not-extensive subgingival debridement as judged by the examining clinician) and/or surgical periodontal treatment within the last 12 months
* Other severe acute or chronic medical or psychiatric condition or psychological disorder, including limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed, or any additional conditions which, in the judgement of the investigator, would make the subject inappropriate for entry into this trial

Primary outcomes:
measure: Changes in the expression of GCF wound healing biomarkers
timeFrame: Baseline, 1, 7, 15, 30 days and 3 months following treatment
Secondary outcomes:
measure: Changes in the Blood flow
timeFrame: Baseline and at 1, 7, 15, and 30 days following treatment.
measure: Changes in the bacterial load
timeFrame: Baseline and at 7, 15, 30 days and 3 months following treatment.
measure: Changes in the probing pocket depth (PPD)
timeFrame: Baseline and at 3 months after intervention
measure: Changes in the gingival recession (REC)
timeFrame: Baseline and at 3 months after intervention
measure: Changes in the clinical attachment level (CAL)
timeFrame: Baseline and at 3 months after intervention
measure: Changes in the Full mouth plaque score (FMPS)
timeFrame: Baseline and at 3 months after intervention
measure: Changes in the Full mouth bleeding score (FMBS)
timeFrame: Baseline and at 3 months after intervention
measure: Changes in the suppuration
timeFrame: Baseline and at 3 months after intervention
measure: Soft tissues contour changes
timeFrame: Baseline, 1, 7, 15, 30 days, and 3 months following treatment
measure: Changes in the periodontal inflamed surface area (PISA)
timeFrame: Baseline and at 3 months after intervention
measure: Dentin hypersensitivity
timeFrame: Baseline, 1, 7, 15, 30 days, and 3 months after procedure
measure: Patient perception about therapy
timeFrame: 1,7 and 15 days after procedure
measure: Global changes in quality of life
timeFrame: 3 months after procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Oral Clinical Research (COCR)
city: London
country: United Kingdom
facility: The Royal London Dental Hospital, Barts Health NHS Trust
Study officials:
affiliation: QMUL
name: Jeniffer Perussolo, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: