The Efficacy of Cyanoacrylate Adhesive (PeriAcryl®90 HV) in Periodontal Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Periodontal Disease, Tissue Adhesive, Dental Scaling, Wound Healing, Oral Surgical Procedures, Pain

Intervention / Treatment
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* Device: PeriAcryl®90 HV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The potential subjects must: Be capable of giving informed consent and 19 years of age or older Have a minimum of 18 teeth and at least 4 measurement sites with pocket depth at least 5.0 mm with bleeding on probing in at least 2 different quadrants Be able to understand and communicate in English, as the study cannot fund a certified interpreter Be willing and able to return for treatment and evaluation throughout the course of this study. Exclusion Criteria: Potential subjects must not: Have had any antibiotics in the last month Be pregnant, nursing or plan to become pregnant over the course of the trial Have an active smoking history (tobacco or otherwise) Have sites with overt abscess, active caries or crown/root fractures Have known adverse reactions or allergies to cyanoacrylates or formaldehyde Have any other significant disease or take medication(s) that, in the opinion of the investigator, may interfere with the evaluation of safety or efficacy of cyanoacrylate and overall compliance.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional: Cyanoacrylate Application<br>Application of cyanoacrylate adhesive to one quadrant of mouth | Device: PeriAcryl®90 HV<br> <br> |
| No Intervention: Control: Absence of Cyanoacrylate Application<br>No application of cyanoacrylate adhesive to the other quadrant of mouth | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale |  | after 6-8 weeks | 
| Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive |  | after 6-8 weeks | 
| Prevention of increased hypersensitivity (hard and soft dental tissues) after NSPT post placement of cyanoacrylate adhesive measured by Visual Analogue Scale |  | after 6-8 weeks | 
| Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale |  | after 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes |  | after 6-8 weeks | 
| Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin |  | after 6-8 weeks | 
| Change in probing pocket depth (PD) |  | after 6-8 weeks | 
| Change in bleeding on probing (BOP) |  | after 6-8 weeks | 
| Change in plaque scores |  | after 6-8 weeks | 
| Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes |  | after 6-8 weeks |