Periodontal DiseasePhase 4NCT02826109
The Efficacy of Cyanoacrylate Adhesive (PeriAcryl®90 HV) in Periodontal Wound Healing
A Phase 4 study testing PeriAcryl®90 HV in people with Periodontal Disease and Tissue Adhesive, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Tissue Adhesive, Dental Scaling
- What is being tested?
- PeriAcryl®90 HV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH, 604 827 0690, penny@dentistry.ubc.ca
Rashi Chaturvedi, BDS, MDS, 604 827 0690, rashi.chaturvedi@alumni.ubc.ca
About this study
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
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.
Read the 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.
- Conditions
- Periodontal Disease, Tissue Adhesive, Dental Scaling, Wound Healing, Oral Surgical Procedures, Pain
- Being tested
- PeriAcryl®90 HV
- Medical subject headings
- Periodontal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriAcryl®90 HVDevice
| Study group | Role | What they receive |
|---|---|---|
| Interventional: Cyanoacrylate Application | Experimental | Application of cyanoacrylate adhesive to one quadrant of mouth Receives: Device: PeriAcryl®90 HV |
| Control: Absence of Cyanoacrylate Application | No intervention | No application of cyanoacrylate adhesive to the other quadrant of mouth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Measured: after 6-8 weeks
Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive
Measured: 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
Measured: after 6-8 weeks
Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Measured: after 6-8 weeks
Secondary outcomes (6)
Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Measured: after 6-8 weeks
Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin
Measured: after 6-8 weeks
Change in probing pocket depth (PD)
Measured: after 6-8 weeks
Change in bleeding on probing (BOP)
Measured: after 6-8 weeks
Change in plaque scores
Measured: after 6-8 weeks
Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Measured: after 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826109
- Sponsor's protocol ID
- H15-03277
- Status last verified
- Jul 2016
- First submitted
- 6 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02826109
- Acronym / sponsor ID
- H15-03277
- Conditions
- Periodontal Disease, Tissue Adhesive, Dental Scaling, Wound Healing, Oral Surgical Procedures, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional: Cyanoacrylate Application | Experimental | Device: PeriAcryl®90 HVApplication 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeriAcryl®90 HV | Device | Interventional: Cyanoacrylate Application |
Primary outcome
Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Time frame: after 6-8 weeks
Change in clinical attachment levels (CAL) after NSPT with adjunctive placement of cyanoacrylate adhesive
Time frame: 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
Time frame: after 6-8 weeks
Continued relief post placement of cyanoacrylate adhesive measured by Visual Analogue Scale
Time frame: after 6-8 weeks
6 secondary outcomes
Subjects' compliance to having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Time frame: after 6-8 weeks
Number of adverse reactions to the placement of cyanoacrylate adhesive at the supra-gingival margin
Time frame: after 6-8 weeks
Change in probing pocket depth (PD)
Time frame: after 6-8 weeks
Change in bleeding on probing (BOP)
Time frame: after 6-8 weeks
Change in plaque scores
Time frame: after 6-8 weeks
Subjects' perception of having the cyanoacrylate adhesive post-operatively by interview and tabulation of patient-reported outcomes
Time frame: after 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PeriAcryl®90 HV in people with Periodontal Disease and Tissue Adhesive, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Penny Hatzimanolakis, DipDH, BDSc, MSc, RDH (604 827 0690, penny@dentistry.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of increased post-operative discomfort post placement of cyanoacrylate adhesive measured by Visual Analogue Scale (time frame: after 6-8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.