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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional: Cyanoacrylate Application | Experimental | Application of cyanoacrylate adhesive to one quadrant of mouth |
|
| Control: Absence of Cyanoacrylate Application | No Intervention | No application of cyanoacrylate adhesive to the other quadrant of mouth |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeriAcryl®90 HV | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
The potential subjects must:
Exclusion Criteria:
Potential subjects must not:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH | Contact | 604 827 0690 | penny@dentistry.ubc.ca | |
| Adam Ludlow, BSc (Mol.Bio.; Biochem.) | Contact | 604 827 0690 | adam.ludlow@dentistry.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T 1Z3 | Canada |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |