PeriodontitisNCT07849647
Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment
A study testing 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment and 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment in people with Periodontitis, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to evaluate and compare the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) using toluidine blue O (TBO) activated by two different diode laser wavelengths as an adjunct to non-surgical periodontal treatment in patients with Stage II and Stage III periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment and 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSyria
- Study dates
- Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older (up to 65 years)
- Participants diagnosed with Periodontitis Stage II-III according to the 2017 classification
- Presence of at least 3 periodontal sites with a probing pocket depth (PPD) of ≥ 5 mm.
- No periodontal treatment during the previous 6 months
- Good general health
Who cannot join
- Presence of systemic diseases or medical conditions that may affect periodontal status, wound healing, or the response to periodontal treatment.
- Use of systemic antibiotics or other medications that may significantly affect periodontal treatment outcomes within the last 6 months.
- Previous periodontal treatment within the last 6 months.
- Known allergy or hypersensitivity to toluidine blue O or any material used in the study.
- Pregnancy or breastfeeding.
- Heavy smoking >10 units/day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wael HosamAldin Almahdi, DDS; MSc; PHD in periodontolog contact
Syria1 site
The study will be conducted at the Faculty of Dentistry, Damascus University, Department of Periodontology, under the supervision of Professor Wael Al- Mahdi.
Damascus
About this study
Official title: Clinical Effectiveness of Diode Laser 635 nm and 810 nm Adjunctive Photodynamic Therapy Versus Mechanical Treatment in Non-Surgical Management of Periodontal Pockets (A Comparative Clinical Study).
This study aims to evaluate and compare the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) using toluidine blue O (TBO) activated by two different diode laser wavelengths as an adjunct to non-surgical periodontal treatment in patients with Stage II and Stage III periodontitis. Participants will be randomly allocated to three treatment groups: non-surgical periodontal treatment combined with aPDT using a 635 nm diode laser, non-surgical periodontal treatment combined with aPDT using an 810 nm diode laser, and non-surgical periodontal treatment alone. The treatment outcomes will be evaluated based on changes in the following clinical periodontal parameters: Plaque Index (PI), Bleeding on Probing (BOP), Relative Attachment Level (RAL), Probing Depth (PD), and Gingival Recession (GR).
Read the detailed description
Several considerations support the need for this study. First, periodontal pockets are among the most common clinical manifestations of periodontal disease. There is also a need for effective treatment modalities that can complement the first-line approach of mechanical periodontal treatment, particularly in deep periodontal pockets and anatomically complex areas.
Antimicrobial photodynamic therapy (aPDT) is an emerging and promising technology in dentistry; however, findings from studies worldwide regarding its superiority over mechanical treatment remain inconsistent. Furthermore, there is a lack of studies directly comparing aPDT using different laser wavelengths with conventional mechanical treatment. Therefore, the findings of this study may provide evidence to support the selection of a more effective treatment option for patients based on scientific evidence.
- Conditions
- Periodontitis
- Being tested
- 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment, 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment, Non-Surgical Periodontal Treatment Alone (Control)
- Keywords
- periodontal therapy, photodynamic therapy, toluidine blue O
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentOther
Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by a 635 nm diode laser. The same treatment procedure will be repeated after two weeks.
810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentOther
Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by an 810 nm diode laser. The same treatment procedure will be repeated after two weeks.
Non-Surgical Periodontal Treatment Alone (Control)Procedure or surgery
Participants assigned to the control group will receive non-surgical periodontal treatment consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips. No photodynamic therapy or laser application will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment | Experimental | Participants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by a 635 nm diode laser. Receives: Other: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment |
| Arm 2: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment | Experimental | Participants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by an 810 nm diode laser. Receives: Other: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment |
| Arm 3: Non-Surgical Periodontal Treatment Alone (Control) | Active comparator | Participants will receive non-surgical periodontal treatment alone, consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips, without photodynamic therapy. Receives: Procedure: Non-Surgical Periodontal Treatment Alone (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing pocket depth (PPD).
Probing pocket depth will be measured in millimeters from the free gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at standardized sites.
Measured: Baseline to 3 months after the first treatment session.
Secondary outcomes (3)
Change in Relative attachment level (RAL)
Relative attachment level (RAL) will be measured in millimeters from a standardized fixed reference point on a vacuum stent to the base of the periodontal pocket, measured using a UNC-15 periodontal probe.
Measured: from baseline to 3 months
Change in Gingival Recession (GR).
Gingival Recession (GR) will be measured in millimeters from the cementoenamel junction (CEJ) to the most apical point of the gingival margin, using a UNC-15 periodontal probe.
Measured: At baseline then 1 month and 3 months after the first session.
Change in Bleeding on Probing (BOP)
The presence or absence of bleeding following standardized periodontal probing to the base of the periodontal pocket. BOP will be recorded as a dichotomous outcome (present/absent) at the selected periodontal sites, and the percentage of BOP-positive sites will be calculated at baseline and at each follow-up visit.
Measured: At baseline then 1 month and 3 months after the first session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849647
- Sponsor's protocol ID
- UDDS-2026-Perio-13
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Hu Z, Zhu X, Li W, Chen J. Treating periodontitis-a systematic review and meta-analysis comparing ultrasonic and manual subgingival scaling at different probing pocket depths. BMC Oral Health. 2020 Jun 25;20(1):176. doi: 10.1186/s12903-020-01117-3.
PubMed 32586315Nie M, Zhang P, Pathak JL, Wang X, Wu Y, Yang J, Shen Y. Photodynamic therapy in periodontitis: A narrative review. Photodermatol Photoimmunol Photomed. 2024 Jan;40(1):e12946. doi: 10.1111/phpp.12946.
PubMed 38288767Annaji S, Sarkar I, Rajan P, Pai J, Malagi S, Bharmappa R, Kamath V. Efficacy of Photodynamic Therapy and Lasers as an Adjunct to Scaling and Root Planing in the Treatment of Aggressive Periodontitis - A Clinical and Microbiologic Short Term Study. J Clin Diagn Res. 2016 Feb;10(2):ZC08-12. doi: 10.7860/JCDR/2016/13844.7165. Epub 2016 Feb 1.
PubMed 27042576Chungkham S, Sambashivaiah S, Kulal R, Devi AN. Comparison of Photodynamic Therapy (PDT) Using Methylene Blue and Toluidine Blue for the Treatment of Chronic Periodontitis- A Clinical and Microbiological Study. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1353-S1355. doi: 10.4103/jpbs.jpbs_124_25. Epub 2025 Jun 18.
PubMed 40655679Maj A, Kusiak A, Garbacz K, Cichonska D, Swietlik D. Photodynamic therapy in non-surgical treatment of periodontitis. Sci Rep. 2025 Feb 18;15(1):5903. doi: 10.1038/s41598-025-89563-3.
PubMed 39966437
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Diode Laser 635 nm and 810 nm Adjunctive Photodynamic Therapy Versus Mechanical Treatment in Non-Surgical Management of Periodontal Pockets (A Comparative Clinical Study).
- ClinicalTrials.gov ID
- NCT07849647
- Acronym / sponsor ID
- UDDS-2026-Perio-13
- Conditions
- Periodontitis
- Keywords
- periodontal therapy, photodynamic therapy, toluidine blue O
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
This study aims to evaluate and compare the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) using toluidine blue O (TBO) activated by two different diode laser wavelengths as an adjunct to non-surgical periodontal treatment in patients with Stage II and Stage III periodontitis. Participants will be randomly allocated to three treatment groups: non-surgical periodontal treatment combined with aPDT using a 635 nm diode laser, non-surgical periodontal treatment combined with aPDT using an 810 nm diode laser, and non-surgical periodontal treatment alone. The treatment outcomes will be evaluated based on changes in the following clinical periodontal parameters: Plaque Index (PI), Bleeding on Probing (BOP), Relative Attachment Level (RAL), Probing Depth (PD), and Gingival Recession (GR).
Detailed description
Several considerations support the need for this study. First, periodontal pockets are among the most common clinical manifestations of periodontal disease. There is also a need for effective treatment modalities that can complement the first-line approach of mechanical periodontal treatment, particularly in deep periodontal pockets and anatomically complex areas.
Antimicrobial photodynamic therapy (aPDT) is an emerging and promising technology in dentistry; however, findings from studies worldwide regarding its superiority over mechanical treatment remain inconsistent. Furthermore, there is a lack of studies directly comparing aPDT using different laser wavelengths with conventional mechanical treatment. Therefore, the findings of this study may provide evidence to support the selection of a more effective treatment option for patients based on scientific evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment | Experimental | Other: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentParticipants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by a 635 nm diode laser. |
| Arm 2: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment | Experimental | Other: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentParticipants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by an 810 nm diode laser. |
| Arm 3: Non-Surgical Periodontal Treatment Alone (Control) | Active comparator | Procedure: Non-Surgical Periodontal Treatment Alone (Control)Participants will receive non-surgical periodontal treatment alone, consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips, without photodynamic therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older (up to 65 years)
- Participants diagnosed with Periodontitis Stage II-III according to the 2017 classification
- Presence of at least 3 periodontal sites with a probing pocket depth (PPD) of ≥ 5 mm.
- No periodontal treatment during the previous 6 months
- Good general health
Key exclusion criteria (6 listed)
- Presence of systemic diseases or medical conditions that may affect periodontal status, wound healing, or the response to periodontal treatment.
- Use of systemic antibiotics or other medications that may significantly affect periodontal treatment outcomes within the last 6 months.
- Previous periodontal treatment within the last 6 months.
- Known allergy or hypersensitivity to toluidine blue O or any material used in the study.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentParticipants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by a 635 nm diode laser. The same treatment procedure will be repeated after two weeks. | Other | Arm 1: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment |
| 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentParticipants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by an 810 nm diode laser. The same treatment procedure will be repeated after two weeks. | Other | Arm 2: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment |
| Non-Surgical Periodontal Treatment Alone (Control)Participants assigned to the control group will receive non-surgical periodontal treatment consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips. No photodynamic therapy or laser application will be performed. | Procedure or surgery | Arm 3: Non-Surgical Periodontal Treatment Alone (Control) |
Primary outcome
Change in probing pocket depth (PPD).
Time frame: Baseline to 3 months after the first treatment session.
Probing pocket depth will be measured in millimeters from the free gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at standardized sites.
3 secondary outcomes
Change in Relative attachment level (RAL)
Time frame: from baseline to 3 months
Change in Gingival Recession (GR).
Time frame: At baseline then 1 month and 3 months after the first session.
Change in Bleeding on Probing (BOP)
Time frame: At baseline then 1 month and 3 months after the first session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 32586315Zhang X, Hu Z, Zhu X, Li W, Chen J. Treating periodontitis-a systematic review and meta-analysis comparing ultrasonic and manual subgingival scaling at different probing pocket depths. BMC Oral Health. 2020 Jun 25;20(1):176. doi: 10.1186/s12903-020-01117-3.
- Background: PubMed 38288767Nie M, Zhang P, Pathak JL, Wang X, Wu Y, Yang J, Shen Y. Photodynamic therapy in periodontitis: A narrative review. Photodermatol Photoimmunol Photomed. 2024 Jan;40(1):e12946. doi: 10.1111/phpp.12946.
- Background: PubMed 27042576Annaji S, Sarkar I, Rajan P, Pai J, Malagi S, Bharmappa R, Kamath V. Efficacy of Photodynamic Therapy and Lasers as an Adjunct to Scaling and Root Planing in the Treatment of Aggressive Periodontitis - A Clinical and Microbiologic Short Term Study. J Clin Diagn Res. 2016 Feb;10(2):ZC08-12. doi: 10.7860/JCDR/2016/13844.7165. Epub 2016 Feb 1.
- Background: PubMed 40655679Chungkham S, Sambashivaiah S, Kulal R, Devi AN. Comparison of Photodynamic Therapy (PDT) Using Methylene Blue and Toluidine Blue for the Treatment of Chronic Periodontitis- A Clinical and Microbiological Study. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1353-S1355. doi: 10.4103/jpbs.jpbs_124_25. Epub 2025 Jun 18.
- Background: PubMed 39966437Maj A, Kusiak A, Garbacz K, Cichonska D, Swietlik D. Photodynamic therapy in non-surgical treatment of periodontitis. Sci Rep. 2025 Feb 18;15(1):5903. doi: 10.1038/s41598-025-89563-3.
- 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.
Wael HosamAldin Almahdi, DDS; MSc; PHD in periodontolog contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment and 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment in people with Periodontitis, run by Damascus University at 1 site in Syria.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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 Syria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SANA MAJALDEEN SALMAN, pursuing aMSc in periodontolog (00963936320891, sansoun.net@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing pocket depth (PPD). (time frame: Baseline to 3 months after the first treatment session.). 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 NCT07849647, which also lists 5 linked publications.
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 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.