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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02826109
• Other study ID #: H15-03277
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 6, 2016
• Last updated: July 6, 2016
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: July 2016
• Source: University of British Columbia
• Contact: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH
• Phone: 604 827 0690
• Email: penny[@]dentistry.ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Scaling
• Gingival Diseases
• Oral Surgical Procedures
• Pain
• Periodontal Disease
• Periodontal Diseases
• Tissue Adhesive
• Wound Healing
• Wounds and Injuries

Intervention

Device:
• PeriAcryl®90 HV

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale		after 6-8 weeks	No
Primary	Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive		after 6-8 weeks	No
Primary	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
Primary	Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale		after 6-8 weeks
Secondary	Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes		after 6-8 weeks	No
Secondary	Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin		after 6-8 weeks	No
Secondary	Change in probing pocket depth (PD)		after 6-8 weeks	No
Secondary	Change in bleeding on probing (BOP)		after 6-8 weeks	No
Secondary	Change in plaque scores		after 6-8 weeks	No
Secondary	Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes		after 6-8 weeks