Pain Clinical Trial
Official title:
The Efficacy of Cyanoacrylate (PeriAcryl®90 HV) in Its Adhesive Post-Operative Properties on Periodontal Wound Healing and Patient Discomfort After Non-Surgical Periodontal Treatment: A Pilot Randomized Clinical Trial
Periodontal disease is a gum infection caused by plaque on teeth containing both bacteria and calculus (hard) deposits. These need to be removed on a regular basis to maintain gum health and to prevent teeth weakening. A routine cleaning procedure, scaling/root planing, is accompanied with post-operative soft tissue tenderness and teeth sensitivity making oral hygiene maintenance difficult during wound healing. The need for novel therapeutic approaches, such as cyanoacrylate adhesives, has been identified. It has been hypothesized that its application may provide comfort and assist patients with their daily oral self-care procedures following teeth cleaning.
Hypothesis: The supra-gingival marginal application of cyanoacrylate adhesive will promote
periodontal wound healing and prevent the increase of sensitivity of hard (teeth) and soft
(gingiva) tissues following non-surgical periodontal therapy (NSPT).
This pilot study involves a small number of participants, and while it is not designed to
prove causation, it will evaluate safety and efficacy. If clinical results are positive,
these data may be used to determine sample and power needs for larger studies.
With enhanced post-operative comfort, the patient's ability to disrupt biofilm and maintain
optimal daily oral self-care can be achieved. Biofilm disruption is paramount to achieving
periodontal health. Specifically, the adjunctive placement of an adhesive dressing may
reduce biofilm accumulation that is associated with periodontal inflammation. This novel
application could improve the patient's oral and thus overall health.
The present pilot trial aims to explore the therapeutic effectiveness of a cyanoacrylate
adhesive (PeriAcryl®90 HV) in reducing patient-reported outcomes related to discomfort and
sensitivity post NSPT, examine their potential positive effects on periodontal wound healing
as well as recording any potential side-effects that may have been experienced by the
patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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