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

University of British Columbia

Status and phase

Unknown

Phase 4

Conditions

Dental Scaling

Oral Surgical Procedures

Tissue Adhesive

Wound Healing

Pain

Periodontal Disease

Treatments

Device: PeriAcryl®90 HV

Study type

Interventional

Funder types

Other

Identifiers

NCT02826109

H15-03277

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.