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

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ClinicalTrials.gov Identifier: NCT02826109
Recruitment Status : Unknown
Verified July 2016 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Tissue Adhesive Dental Scaling Wound Healing Oral Surgical Procedures Pain Device: PeriAcryl®90 HV Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional: Cyanoacrylate Application
Application of cyanoacrylate adhesive to one quadrant of mouth
Device: PeriAcryl®90 HV
No Intervention: Control: Absence of Cyanoacrylate Application
No application of cyanoacrylate adhesive to the other quadrant of mouth



Primary Outcome Measures :
  1. Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale [ Time Frame: after 6-8 weeks ]
  2. Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive [ Time Frame: after 6-8 weeks ]
  3. 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 ]
  4. Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale [ Time Frame: after 6-8 weeks ]

Secondary Outcome Measures :
  1. Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes [ Time Frame: after 6-8 weeks ]
  2. Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin [ Time Frame: after 6-8 weeks ]
  3. Change in probing pocket depth (PD) [ Time Frame: after 6-8 weeks ]
  4. Change in bleeding on probing (BOP) [ Time Frame: after 6-8 weeks ]
  5. Change in plaque scores [ Time Frame: after 6-8 weeks ]
  6. Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes [ Time Frame: after 6-8 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826109


Contacts
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Contact: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH 604 827 0690 penny@dentistry.ubc.ca
Contact: Adam Ludlow, BSc (Mol.Bio.; Biochem.) 604 827 0690 adam.ludlow@dentistry.ubc.ca

Locations
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Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH    604 827 0690    penny@dentistry.ubc.ca   
Contact: Rashi Chaturvedi, BDS, MDS    604 827 0690    rashi.chaturvedi@alumni.ubc.ca   
Principal Investigator: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH         
Sub-Investigator: Rashi Chaturvedi, BDS, MDS         
Sub-Investigator: Hannu Larjava, DDS, PhD, DipPerio         
Sub-Investigator: Edward E. Putnins, DMD, DipPerio, MRCD, MSc, PhD         
Sub-Investigator: Lari Hakkinen, DDS, PhD         
Sub-Investigator: Marissa Garcia Fulle de Owen, DDS, MSc, DipPerio         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02826109     History of Changes
Other Study ID Numbers: H15-03277
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Periodontal Diseases
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases