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Chronic PeriodontitisPhase 4NCT02391974

Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets

A Phase 4 study testing PERIOSYAL FILL in people with Chronic Periodontitis, run by Teoxane SA at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a controlled, randomized, single-blinded, multicenter, prospective clinical study. In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral… Read more about this study

Who is it for?
Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
PERIOSYAL FILL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesGermany
Study dates
Feb 2015to Jul 2017
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 25 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men or women, aged between 25 and 60 years
  • Patients with at least 20 natural teeth
  • Patient with periodontitis confirmed by a X-ray diagnosis, and having at least 4 teeth with periodontal pockets with probing depth between 4 and 6 mm
  • Willing to understand and comply with study requirements and to sign informed consent

Who cannot join

  • Patient with an active smoking status
  • Patient with an antibiotic therapy within the previous 4 weeks
  • Need for continuous medical treatment within 2 weeks prior to enrollment
  • Ongoing inflammatory state or a systemic illness that may affect the oral cavity
  • Patient with hypofunction in saliva productions (e.g. Sjögren Syndrome with Xerostomia)
  • History of active chronic debiliating systemic disease, including insulin or non-insulin dependent diabetes
Show all 14Show fewer
  • Patients with bleeding disorders
  • History of allergies to gram positive bacterial proteins
  • History of hypersensitivity and/or idiosyncrasies to any of the test compounds, e.g. hyaluronic acid or other device compounds
  • History of multiple severe allergies, history of anaphylactic shock
  • History of connective tissue disease (rheumatoid arthritis, scleroderma, systemic lupus erythematosus) or of any other autoimmunity disease
  • History of herpetic lesion or lichen planus
  • Pregnant or breast feeding women, or female subjects of childbearing potential who did not intend to practice medically acceptable method of contraception
  • Participation in another clinical study in the previous 3 months

Trial locations and contacts

3 sites in 1 country.

Germany3 sites, 3 recruiting

  • Dental Specialist

    Düsseldorf

    Marcel WAINWRIGHT, wainwright@dentalspecialists.de

    Marcel WAINWRIGHT

    Recruiting

  • Dr. Wahlmann & Partner

    Edewecht

    Jürgen WAHLMANN, dr.wahlmann@web.de

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Ralf SMEETS, r.smeets@uke.de

    Not yet recruiting

Other trials in Germany

About this study

Official title: Filling of Periodontal Pockets With a Commercially Available Injectable Cross-linked Hyaluronic Acid Dental Filler Versus Oral Hygiene Alone, After Scaling and Root Planing and Chlorhexidine Disinfection, for the Treatment of Periodontitis: A Single-blinded, Multi Center, Prospective, Randomized Controlled Trial

This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.

In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

The pocket depth will be measured at six sites around each tooth, and only the deepest pocket sites of each tooth will be taken into account.

Read the detailed description

This is a controlled, randomized, single-blinded (independent Blinded Evaluator), multicenter, prospective clinical study.

Each subject will receive the standard periodontal treatment procedure on all teeth that need to be treated. The usual cares are scaling and root planing (SRP), and chlorhexidine, and instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily, and prevention : sugar intake, alcohol consumption, fluoride level).

Two other optional treatment sessions with SRP could be performed, if deemed necessary by the Treating Investigator. Those optional SRP session could only be performed after all study-related clinical assessement.

The pocket depth of every teeth will be measured at six sites around each tooth, and only the deepest pocket sites will be taken into account. The 4 teeth with the deepest pockets will be included in the study and randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

Being tested
PERIOSYAL FILL
Keywords
Hyaluronic acid, Periodontal pockets, Periodontitis
Medical subject headings
Chronic Periodontitis, Periodontal Pocket, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PERIOSYAL FILLDevice

    Injection 2 weeks after standard periodontal treatment procedure on all teeth that need to be treated.

    Touch-up treatment provided at 3 and 6 weeks.

Study groups in NCT02391974
Study groupRoleWhat they receive
PERIOSYAL FILLExperimentaln=15
Receives: Device: PERIOSYAL FILL
No treatment (untreated control)No interventionn=15

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pocket Probing Depth (PPD)

    PPD is defined as the distance from the gingival margin to the base of the gingival crevice, i.e. the bottom of the clinical pocket. PPD will be measured at six sites per tooth (DV, V, MV, DL, L, ML), using a constant-force computerized periodontal probe with a 0.2 mm precision. Only the deepest will be taken into account

    Measured: Pre-injection, to 12, 24 and 48 weeks after baseline

Secondary outcomes (12)

  1. Change in Pocket Probing Depth (PPD)

    Measured: Pre-injection, to 2, 5, 8 and 36 weeks after baseline

  2. Change in Clinical Attachment Level (CAL)

    CAL is defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket (the bottom of the clinical pocket)

    Measured: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  3. Bleeding On Probing (BOP)

    BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing

    Measured: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  4. Tooth Mobility

    Tooth Mobility will be assessed on the scale defined by Muehlemann

    Measured: Pre-injection, to 12, 24, 36 and 48 weeks after baseline

  5. Plaque Index (PI)

    PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index

    Measured: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  6. Gingival Index (GI)

    GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index

    Measured: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  7. Oral Health-related quality of life

    Oral Health-related quality of life is a patient reported outcome measure specifically pertaining to oral health capturing both the functional, social and psychological impacts of oral disease, assessed using the OHQoL-GE, a validated translation of the OHQoL-UK

    Measured: Pre-injection, to 12, 24, 36 and 48 weeks after baseline

  8. Microbiological analysis of the 11 main periodontal pathogens

    Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points

    Measured: : Pre-injection, to 12, 24, 36 and 48 weeks after baseline

  9. Physician satisfaction with the treatment

    Satisfaction will be assessed on a 5-grade subjective symmetrical scale

    Measured: 12, 24, 36 and 48 weeks after baseline

  10. Subject Satisfaction with the treatment

    Satisfaction will be assessed on a 5-grade subjective symmetrical scale

    Measured: 12, 24, 36 and 48 weeks after baseline

  11. Total volume of product injected in each of the included teeth

    Volume will be measured to an accuracy of 0.025 mL

    Measured: during each injection session

  12. Pain felt by the patient in the aera (tooth, gum)

    Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS)

    Measured: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionOct 2016 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391974
Sponsor's protocol ID
TEO-PER-1401
Status last verified
Jun 2016
First submitted
12 Mar 2015
Last updated
10 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PERIOSYAL FILL in people with Chronic Periodontitis, run by Teoxane SA at 3 sites in Germany.

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 4 inclusion and 14 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 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pocket Probing Depth (PPD) (time frame: Pre-injection, to 12, 24 and 48 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02391974.

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 10 Jun 2016.

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