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Chronic PeriodontitisPhase 4NCT01532674

Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

A Phase 4 study testing Antimicrobial photodynamic therapy (Periowave) and scaling and root planing and scaling and root planing in people with Chronic Periodontitis, run by Francisco Alpiste Illueca at 1 site in Spain.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The goal of this study is to determine if patients with chronic periodontitis when undergoing with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone result in improved clinical, microbiological and biochemical outcomes. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
Antimicrobial photodynamic therapy (Periowave) and scaling and root planing and scaling and root planing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
Nov 2011to Apr 2013
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Chronic generalized moderate-advanced periodontitis: based on "Classification System for Periodontal Diseases and Conditions" Armitage 1999. (24).Extension of the 30 % of affected zones. Severity base on clinical attachment loss: moderate = 3-4 mm of CAL, severe= > or equal 5 mm CAL.
  • The subject is diagnosed with moderate or advanced chronic periodontitis.
  • The subject has at least 4 sites with PD of ≥5 mm + bleeding in at least two quadrants of the mouth.
  • A signed Informed Consent will be obtained.
  • The subject is an adult male or female > 18 years of age.
  • The subject has >18 fully erupted teeth, at least 3 teeth in each quadrant with one or more posterior teeth per quadrant (3º molars excluded).
  • The subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study.

Who cannot join

  • The subject is pregnant or nursing or plans to become pregnant in the next 6 months.
  • The subject is a current smoker.
  • The subject has an active malignancy of any type by subject report.
  • The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol.
  • The subject has any significant chronic disease (either acute or chronic) or who is taking a medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of the study.
  • The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
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  • The subject has been treated with antibiotics within the 3-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc.) by report of the subject.
  • The subject has a known allergy to Methylene Blue, polimetil metacrilate or chlorhexidine.
  • The subject Has severe glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report.
  • The subject currently uses anti-coagulant therapy at therapeutic doses.
  • The subject is currently using any photosensitizing medications.
  • Patients who have received SRP or Periodontal supportive therapy in the last 6 months
  • It is considered > 30% of plaque of an index of 2 or more in the Silness y Löe plaque index the patient in the study.

Trial locations and contacts

1 site in 1 country.

Alpiste Francisco, Professor contact

963983136 ext. 011 34

francisco.alpiste@uv.es

Spain1 site, 1 recruiting

  • University of Valencia

    Valencia, Valencia, 46010

    Segarra Marta, Postgraduate, 653838086 ext. 011 34, marta_segarra_vidal@hotmail.com

    Recruiting

Other trials in Spain

About this study

The goal of this study is to determine if patients with chronic periodontitis when undergoing with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone result in improved clinical, microbiological and biochemical outcomes.

Read the detailed description

This research is orientated to find an effective way to kill oral microorganisms that cause periodontitis and gingivitis with no problems of resistance, as it happens when we use antibiotics. The efficacy of this low power laser has been demonstrated in numerous fields in medicine and have been use it for years. The application of the photodynamic therapy is easy since we only have to fill the periodontal pocket with the photosensitive agent and apply the low power laser in that area. The photosensitive agent stain the bacteria immediately and the laser disrupts its membrane by a free-radical reaction. Improving the health status of the patients in a few weeks after treatment.

Being tested
Antimicrobial photodynamic therapy (Periowave) and scaling and root planing, scaling and root planing
Medical subject headings
Chronic Periodontitis

What participants receive

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

  • Antimicrobial photodynamic therapy (Periowave) and scaling and root planingDevice

    Also called Periowave

    ROOT PLANNING PROCEDURE:

    The procedure is the same as in the control group

    APPLICATION PROCEDURES OF THE PHOTOSENSITIZING AGENT :

    The photosensitive agent : Formulation Periowave Treatment Kit-2ml

    • Application of the photosensitive using a blunt needle at the bottom of the periodontal pocket with circular movements covering the entire perimeter of the tooth.
    • Application of diode laser with a peak of 8.5 cm. long with a curvature of 60 degrees and flexible. Making a move in and out from the apical region to the more coronal region of the periodontal pocket. Each tooth has a working time of 60 seconds.
    • All the periodontal pockets will be treated subgingivally
    • Elimination of the photosensitive by irrigation

  • scaling and root planingProcedure or surgery

    ROOT PLANNING PROCEDURE:

    An unique operator ( independent from the explorer) will do the root planing for both the test and control group.

    Every procedure will be done under local anaesthesia: Ultracain with Epinephrine 40/0,01 mg/ml. NORMON. It will be done a first session of root planning in the first and forth quadrant and in a 48 hours the root planning of the second and the third quadrant will be done. Every session wil be done with this material: Ultrasonic: Satelec suprasson p5 with ultrasonic tip H3, manual scalers: HU-FRIEDY 1/2, 7/8, 11/12, 13/14, 13/14 columbia.

    • The session will finish as soon as the operator have removed all the supragingival and subgingival calculus and plaque.
Study groups in NCT01532674
Study groupRoleWhat they receive
Antimicrobial photodynamic therapyExperimentalAntimicrobial photodynamic therapy and scaling and root planing
Receives: Device: Antimicrobial photodynamic therapy (Periowave) and scaling and root planing
scaling and root planingActive comparatorOnly scaling and root planing
Receives: Procedure: scaling and root planing

What is being measured

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

  1. Improvement in Clinical Attachment Level

    Measured: 6 months

Secondary outcomes (6)

  1. Improvement in Periodontal Pocket Depth

    Measured: 6 months

  2. Improvement in Bleeding on Probing

    Measured: 6 months

  3. Levels of IL-1

    Measured: 6 months.

  4. levels of IL-6

    Measured: 6 months

  5. Levels of FNT-alfa

    Measured: 6 months

  6. Levels of RANKL-OPJ.

    Measured: 6 months

Timeline

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

  1. First posted14 Feb 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionApr 2013 (estimated)
  4. Study completionApr 2013 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532674
Sponsor's protocol ID
UV1
Status last verified
Feb 2012
First submitted
9 Nov 2011
Last updated
20 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Antimicrobial photodynamic therapy (Periowave) and scaling and root planing and scaling and root planing in people with Chronic Periodontitis, run by Francisco Alpiste Illueca at 1 site in Spain.

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 7 inclusion and 13 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 20 Feb 2012. 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 Spain. 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 Alpiste Francisco, Professor (963983136 ext. 011 34, francisco.alpiste@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Clinical Attachment Level (time frame: 6 months). 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 NCT01532674.

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 20 Feb 2012.

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