- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826109
The Efficacy of Cyanoacrylate Adhesive (PeriAcryl®90 HV) in Periodontal Wound Healing
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional: Cyanoacrylate Application
Application of cyanoacrylate adhesive to one quadrant of mouth
|
|
No Intervention: Control: Absence of Cyanoacrylate Application
No application of cyanoacrylate adhesive to the other quadrant of mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive
Time Frame: after 6-8 weeks
|
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
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Change in probing pocket depth (PD)
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Change in bleeding on probing (BOP)
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Change in plaque scores
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Time Frame: after 6-8 weeks
|
after 6-8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-03277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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