NCT02826109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

June 6, 2016

Last Update Submit

July 6, 2016

Conditions

Periodontal DiseaseTissue AdhesiveDental ScalingWound HealingOral Surgical ProceduresPain

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (6)

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Interventional: Cyanoacrylate Application

EXPERIMENTAL

Application of cyanoacrylate adhesive to one quadrant of mouth

Device: PeriAcryl®90 HV

Control: Absence of Cyanoacrylate Application

NO INTERVENTION

No application of cyanoacrylate adhesive to the other quadrant of mouth

Interventions

PeriAcryl®90 HVDEVICE
Interventional: Cyanoacrylate Application

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Periodontal DiseasesPain

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH

CONTACT

604 827 0690penny@dentistry.ubc.ca

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

CONTACT

604 827 0690adam.ludlow@dentistry.ubc.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

July 7, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

January 1, 2018

Last Updated

July 7, 2016

Record last verified: 2016-07

Locations

CA(1)