Aggressive PeriodontitisNCT05655338
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
A study testing antimicrobial photodynamic therapy and systemic antibiotics in people with Aggressive Periodontitis, run by University of Ljubljana.
Trial summary
Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive… Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- antimicrobial photodynamic therapy and systemic antibiotics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2015to 30 Jun 2016
- Phase
- Interventional
- 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 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aggressive periodontitis (stage III, grade C periodontitis)
- nonsmokers
- at least 20 teeth in oral cavity
- systemically healthy
Who cannot join
- any previous periodontal treatment
- smoking
- pregnancy
- ingestion of systemic antibiotics within three months before therapy
About this study
Official title: Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment
Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.
Read the detailed description
Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.
- Conditions
- Aggressive Periodontitis
- Being tested
- antimicrobial photodynamic therapy, systemic antibiotics
- Keywords
- Photodynamic therapy, Antibiotic therapy
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial photodynamic therapyDevice
Also called HELBO TheraLite Laser
systemic antibioticsDrug
Also called Amoxicillin (Hiconcil), Metronidazole (Efloran)
| Study group | Role | What they receive |
|---|---|---|
| ANTIMICROBIAL PHOTODYNAMIC THERAPY | Experimental | The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment Receives: Device: antimicrobial photodynamic therapy |
| SYSTEMIC ANTIBIOTICS | Experimental | The patients received systemic antibiotics after non-surgical periodontal treatment Receives: Drug: systemic antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth reduction
Change in probing depth
Measured: 3 months
Bleeding on probing
Bleeding after measurement of probing depth
Measured: 3 months
Secondary outcomes (1)
Clinical attachment loss
Change in clinical attachment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start10 Jan 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Gaspirc, Assoc.prof., Study chair, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655338
- Sponsor's protocol ID
- PHOTODYNAMICTHERAPY
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT05655338
- Acronym / sponsor ID
- PHOTODYNAMICTHERAPY
- Conditions
- Aggressive Periodontitis
- Keywords
- Photodynamic therapy, Antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 19 Dec 2022 (actual)
- 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.
Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.
Detailed description
Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANTIMICROBIAL PHOTODYNAMIC THERAPY | Experimental | Device: antimicrobial photodynamic therapyThe patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment |
| SYSTEMIC ANTIBIOTICS | Experimental | Drug: systemic antibioticsThe patients received systemic antibiotics after non-surgical periodontal treatment |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aggressive periodontitis (stage III, grade C periodontitis)
- nonsmokers
- at least 20 teeth in oral cavity
- systemically healthy
Key exclusion criteria (4 listed)
- any previous periodontal treatment
- smoking
- pregnancy
- ingestion of systemic antibiotics within three months before therapy
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 |
|---|---|---|
| antimicrobial photodynamic therapyAlso: HELBO TheraLite Laser | Device | ANTIMICROBIAL PHOTODYNAMIC THERAPY |
| systemic antibioticsAlso: Amoxicillin (Hiconcil), Metronidazole (Efloran) | Drug | SYSTEMIC ANTIBIOTICS |
Primary outcome
Probing depth reduction
Time frame: 3 months
Change in probing depth
Bleeding on probing
Time frame: 3 months
Bleeding after measurement of probing depth
1 secondary outcome
Clinical attachment loss
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Boris Gaspirc, Assoc.prof. study chair
University of Ljubljana
Questions about this trial
What is this clinical trial studying?
A study testing antimicrobial photodynamic therapy and systemic antibiotics in people with Aggressive Periodontitis, run by University of Ljubljana.
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 4 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: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 depth reduction (time frame: 3 months). The study lists 2 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 19 Dec 2022.