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

NCT ID: NCT02826109

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-01-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interventional: Cyanoacrylate Application

Application of cyanoacrylate adhesive to one quadrant of mouth

Group Type EXPERIMENTAL

PeriAcryl®90 HV

Intervention Type DEVICE

Control: Absence of Cyanoacrylate Application

No application of cyanoacrylate adhesive to the other quadrant of mouth

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PeriAcryl®90 HV

Intervention Type DEVICE

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH

Role: CONTACT

604 827 0690

Adam Ludlow, BSc (Mol.Bio.; Biochem.)

Role: CONTACT

604 827 0690

Facility Contacts

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Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH

Role: primary

604 827 0690

Rashi Chaturvedi, BDS, MDS

Role: backup

604 827 0690

Other Identifiers

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H15-03277

Identifier Type: -

Identifier Source: org_study_id

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