PeriodontitisNCT06305533
Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis
A study testing LASER disinfection, Photodynamic therapy and Root surface debridement in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- LASER disinfection, Photodynamic therapy and Root surface debridement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2024to Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.
Who cannot join
- Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad
Baghdad, 10047
+964 14169394, master@codental.uobaghdad.edu.iq
About this study
Official title: Efficacy of Photodynamic Therapy and LASER Disinfection as Adjunct to Nonsurgical Periodontal Therapy for Treatment of Periodontitis: Randomized Clinical Trial
The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:
Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.
Read more
Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.
All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.
All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.
- Conditions
- Periodontitis
- Being tested
- LASER disinfection, Photodynamic therapy, Root surface debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER disinfectionDevice
In test group 1, the diode Laser will be used to disinfect the inner layer of the pockets and thus reducing the microbial load. Diode laser (Biolase, EpicX, BIOLASE, Inc, USA) settings will be as follows: wavelength: 940nm; power: 1W; 300μm uninitiated fibers; continuous radiation mode; and energy level: 80 J/s. The laser fibers then will be inserted into the pockets in such a way that they will be in contact with the soft tissue wall of the pockets and parallel to the root surface and then will be moved to the apical surface through a horizontal sweeping motion (1mm/s) while remaining in contact with the soft tissue wall of the pockets.
Photodynamic therapyDevice
the second test group will receive additional adjunctive aPDT using a ICG photosensitizer activated with diode laser. In details, pockets will be irrigated by a syringe loaded with an ICG photosensitizer solution (Verdye, Diagnostic green, Germany) at a concentration of 5mg/ml. The ICG solution will be allowed to stay in the pockets for 2min, and washing out excess solution from the pockets before laser irradiation. Afterwards, a 300μm bulb optical fibre of the 810nm diode laser unit (QuickLase, United Kingdom) set at 300mw in pulsed mode (100ms ON/100ms OFF) will be inserted along the pocket and activated for 30s with continuous vertical movements from the bottom of the pocket to the gingival margin
Root surface debridementProcedure or surgery
For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Root surface debridement only Receives: Procedure: Root surface debridement |
| Test group 1 (Biolase group) | Active comparator | Root surface debridement and laser disinfection, the diode Laser (Bolas) will be used to disinfect the inner layer of the pockets and thus reducing the microbial load. Receives: Device: LASER disinfection; Procedure: Root surface debridement |
| Test group 2 (Quicklase group) | Active comparator | Root surface debridement and photodynamic therapy using a Indocyanine green photosensitizer activated with diode laser (Quicklase) Receives: Device: Photodynamic therapy; Procedure: Root surface debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD)
PPD will be measured from the gingival margin to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .
Measured: over a period of 3 months.
Secondary outcomes (4)
Bleeding on probing (BOP)
The BOP will be scored as 0 (absent) and 1 (present) after probing within 30s by quadrant using UNC-15 periodontal probe .
Measured: over a period of 3 months.
Plaque index (PI)
Biofilm will be determined using a dichotomous scoring system as presence (1) or absence (0). Disclosing solution will be used to assess agreement on scoring of biofilm.
Measured: over a period of 3 months.
Clinical attachment loss (CAL)
CAL will be measured from the cementoenamel junction to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .
Measured: over a period of 3 months.
Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum
Real time PCR will be used to assess the detection of the following periodontal pathogens in the subgingival biofilm samples: F. nucleatum and F. fastidiosum, according to manufacturer's instructions. Identification of target bacteria through PCR will be executed using species specific primers.
Measured: over a period of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahraa Talib Abid, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305533
- Sponsor's protocol ID
- 854623
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photodynamic Therapy and LASER Disinfection as Adjunct to Nonsurgical Periodontal Therapy for Treatment of Periodontitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06305533
- Acronym / sponsor ID
- 854623
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:
Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.
Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.
All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.
All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Root surface debridementRoot surface debridement only |
| Test group 1 (Biolase group) | Active comparator | Device: LASER disinfection, Procedure: Root surface debridementRoot surface debridement and laser disinfection, the diode Laser (Bolas) will be used to disinfect the inner layer of the pockets and thus reducing the microbial load. |
| Test group 2 (Quicklase group) | Active comparator | Device: Photodynamic therapy, Procedure: Root surface debridementRoot surface debridement and photodynamic therapy using a Indocyanine green photosensitizer activated with diode laser (Quicklase) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects (>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.
Key exclusion criteria (1 listed)
- Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.
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 |
|---|---|---|
| LASER disinfectionIn test group 1, the diode Laser will be used to disinfect the inner layer of the pockets and thus reducing the microbial load. Diode laser (Biolase, EpicX, BIOLASE, Inc, USA) settings will be as follows: wavelength: 940nm; power: 1W; 300μm uninitiated fibers; continuous radiation mode; and energy level: 80 J/s. The laser fibers then will be inserted into the pockets in such a way that they will be in contact with the soft tissue wall of the pockets and parallel to the root surface and then will be moved to the apical surface through a horizontal sweeping motion (1mm/s) while remaining in contact with the soft tissue wall of the pockets. | Device | Test group 1 (Biolase group) |
| Photodynamic therapythe second test group will receive additional adjunctive aPDT using a ICG photosensitizer activated with diode laser. In details, pockets will be irrigated by a syringe loaded with an ICG photosensitizer solution (Verdye, Diagnostic green, Germany) at a concentration of 5mg/ml. The ICG solution will be allowed to stay in the pockets for 2min, and washing out excess solution from the pockets before laser irradiation. Afterwards, a 300μm bulb optical fibre of the 810nm diode laser unit (QuickLase, United Kingdom) set at 300mw in pulsed mode (100ms ON/100ms OFF) will be inserted along the pocket and activated for 30s with continuous vertical movements from the bottom of the pocket to the gingival margin | Device | Test group 2 (Quicklase group) |
| Root surface debridementFor all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes. | Procedure or surgery | Control, Test group 1 (Biolase group), Test group 2 (Quicklase group) |
Primary outcome
Probing Pocket Depth (PPD)
Time frame: over a period of 3 months.
PPD will be measured from the gingival margin to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .
4 secondary outcomes
Bleeding on probing (BOP)
Time frame: over a period of 3 months.
Plaque index (PI)
Time frame: over a period of 3 months.
Clinical attachment loss (CAL)
Time frame: over a period of 3 months.
Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum
Time frame: over a period of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASER disinfection, Photodynamic therapy and Root surface debridement in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 1 inclusion and 1 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 12 Mar 2024. 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 Iraq. 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.
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 Zahraa Talib, B.D.S (009647724342248, zahraa.abd2205@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (PPD) (time frame: over a period of 3 months.). 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 12 Mar 2024.