Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт Hyaluronic Acid (HA) and Octenidine gel
  A thermosensitive gel with Hyaluronic Acid (HA) and Octenidine (Pocket-X®, Geistlich, Wolhusen, Switzerland) will be applied in the periodontal pockets ≥5mm immediately after the subgingival PMPR, by means of a pre-filled syringe bearing a thin plastic tip and following manufacturer's instructions.
• Процедура Non-surgical periodontal treatment (NSPT)
  Full mouth supragingival professional mechanical plaque removal (PMPR) and subgingival PMPR at sites with PPD ≥4mm will be performed with the aid of manual and power-driven instruments under local anaesthesia.

Первичные конечные точки

• Changes in the expression of GCF wound healing biomarkers [Срок оценки: Baseline, 1, 7, 15, 30 days and 3 months following treatment]

Вторичные конечные точки (12)

• Changes in the Blood flow [Срок оценки: Baseline and at 1, 7, 15, and 30 days following treatment.]
• Changes in the bacterial load [Срок оценки: Baseline and at 7, 15, 30 days and 3 months following treatment.]
• Changes in the probing pocket depth (PPD) [Срок оценки: Baseline and at 3 months after intervention]
• Changes in the gingival recession (REC) [Срок оценки: Baseline and at 3 months after intervention]
• Changes in the clinical attachment level (CAL) [Срок оценки: Baseline and at 3 months after intervention]
• Changes in the Full mouth plaque score (FMPS) [Срок оценки: Baseline and at 3 months after intervention]
• Changes in the Full mouth bleeding score (FMBS) [Срок оценки: Baseline and at 3 months after intervention]
• Changes in the suppuration [Срок оценки: Baseline and at 3 months after intervention]
• Soft tissues contour changes [Срок оценки: Baseline, 1, 7, 15, 30 days, and 3 months following treatment]
• Changes in the periodontal inflamed surface area (PISA) [Срок оценки: Baseline and at 3 months after intervention]
• Dentin hypersensitivity [Срок оценки: Baseline, 1, 7, 15, 30 days, and 3 months after procedure]
• Patient perception about therapy [Срок оценки: 1,7 and 15 days after procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 2 центра

• Centre for Oral Clinical Research (COCR) — London
• The Royal London Dental Hospital, Barts Health NHS Trust — London

Идентификаторы

NCT: NCT06522438 · 346806

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗