Chronic PeriodontitisPhase 2/3NCT01330082
Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis
A Phase 2/3 study testing Adjunctive Photodynamic Therapy, Light-emitting diod Irradiation and applying Photosensitizer in people with Chronic Periodontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Adjunctive Photodynamic Therapy, Light-emitting diod Irradiation and applying Photosensitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIran
- Study dates
- Apr 2010to May 2011
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss
- presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant
- at least 16 remaining teeth
- no periodontal treatment in the past 12 months
- no evidence of systemic disease related to periodontal problems
- no use of antibiotics for the past 6 months
Show all 9Show fewer
- No smoking more than 10 cigarettes per day
- no addiction to any kind of drugs
- no pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences
Tehran, Tehran Province, 141555583
About this study
Official title: Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis
The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.
- Conditions
- Chronic Periodontitis
- Being tested
- Adjunctive Photodynamic Therapy, Light-emitting diod Irradiation, applying Photosensitizer
- Keywords
- Photodynamic therapy, Light-emitting diode, toluidine blue, 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.
Adjunctive Photodynamic TherapyOther
using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
Light-emitting diod IrradiationOther
625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
applying PhotosensitizerOther
toluidine blue O is applied at the bottom of each periodontal pocket
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy | Experimental | will be treated by PDT using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO) Receives: Other: Adjunctive Photodynamic Therapy |
| Light-emitting diode Irradiation | Experimental | will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) Receives: Other: Light-emitting diod Irradiation |
| applying photosensitizer | Experimental | will be treated only by toluidine blue O Receives: Other: applying Photosensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
distance from gingival margin to base of the clinical pocket by William's periodontal probe
Measured: Baseline, one month, three month
Secondary outcomes (3)
Clinical attachment loss
distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites
Measured: Baseline, one month, three month
Bleeding upon probing
presence or the absence of bleeding up to 30 second after probing with a William's periodontal probe
Measured: Baseline, one month, three month
plaque index
teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3
Measured: Baseline,before PDT procedure, one month, three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Neda Moslemi, DDS,MS, Study chair, Tehran University of Medical SciencesSeyed Hossein Bassir, DDS, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330082
- Sponsor's protocol ID
- 09123209916
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01330082
- Acronym / sponsor ID
- 09123209916
- Conditions
- Chronic Periodontitis
- Keywords
- Photodynamic therapy, Light-emitting diode, toluidine blue, scaling and root planing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (estimated)
- First posted
- 6 Apr 2011 (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.
The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | Experimental | Other: Adjunctive Photodynamic Therapywill be treated by PDT using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO) |
| Light-emitting diode Irradiation | Experimental | Other: Light-emitting diod Irradiationwill be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) |
| applying photosensitizer | Experimental | Other: applying Photosensitizerwill be treated only by toluidine blue O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss
- presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant
- at least 16 remaining teeth
- no periodontal treatment in the past 12 months
- no evidence of systemic disease related to periodontal problems
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adjunctive Photodynamic Therapyusing Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO) | Other | Photodynamic therapy |
| Light-emitting diod Irradiation625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark | Other | Light-emitting diode Irradiation |
| applying Photosensitizertoluidine blue O is applied at the bottom of each periodontal pocket | Other | applying photosensitizer |
Primary outcome
Probing pocket depth
Time frame: Baseline, one month, three month
distance from gingival margin to base of the clinical pocket by William's periodontal probe
3 secondary outcomes
Clinical attachment loss
Time frame: Baseline, one month, three month
Bleeding upon probing
Time frame: Baseline, one month, three month
plaque index
Time frame: Baseline,before PDT procedure, one month, three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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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.
Neda Moslemi, DDS,MS study chair
Tehran University of Medical Sciences
Seyed Hossein Bassir, DDS principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adjunctive Photodynamic Therapy, Light-emitting diod Irradiation and applying Photosensitizer in people with Chronic Periodontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 9 inclusion and 0 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 6 Apr 2011. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: Baseline, one month, three month). 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 6 Apr 2011.