Stage III PeriodontitisNCT07368699
Active Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis
A study testing Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Scaling and root planing and topical application of active oxygen-releasing gel and Scaling and root planing in people with Stage III Periodontitis, run by Alexandria University at 1 site in Egypt.
Trial summary
Periodontitis is a serious gum disease that can damage the tissues supporting the teeth. The standard treatment is scaling and root planing of the teeth and roots. However, in some patients, this treatment alone may not fully control inflammation and harmful bacteria. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stage III Periodontitis
- What is being tested?
- Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Scaling and root planing and topical application of active oxygen-releasing gel and Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2025to Dec 2026
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with periodontal diagnosis of stage III periodontitis
- Patients with residual periodontal pocket depth ≥4 mm ,CAL≥ 5mm with bone loss extending to middle third of root and beyond in radiography
- Bleeding on probing at least four sites at base-line
- Patients who didn't receive periodontal treatment for a minimum of 3 months prior to the examination.
- Patients of both sexes aged ≥30 and ≤70 years
Who cannot join
- Smokers or those with any other harmful habits such as pipe or vape smoking
- Patients with any systemic condition that will possibly affect the outcome of periodontal therapy i.e. (diabetic patients)
- Patients who have received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months
- Pregnant or lactating women
- Patients with parafunctional habits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aliaa Gamaleldin Aboulela, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, Bab Sharq, 21578
Faculty of Dentistry, Alexandria University, +2034868066, dent.admin@alexu.edu.eg
About this study
Official title: Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)
Periodontitis is a serious gum disease that can damage the tissues supporting the teeth. The standard treatment is scaling and root planing of the teeth and roots. However, in some patients, this treatment alone may not fully control inflammation and harmful bacteria.
This study aims to evaluate whether adding an active oxygen-releasing gel, with or without photodynamic therapy, improves treatment outcomes in patients with stage III periodontitis. The oxygen-releasing gel is applied to the gums and releases oxygen, which may help reduce harmful bacteria. Photodynamic therapy uses a light source together with a special dye to target and destroy bacteria and improve gingival health.
Read more
In this randomized clinical trial, 42 patients with stage III periodontitis will be divided into three groups. One group will receive standard scaling and root planing (SRP) plus the oxygen-releasing gel. A second group will receive standard scaling and root planing (SRP)plus the gel and photodynamic therapy. The third group will receive standard scaling and root planing(SRP) only.
Gum health will be evaluated by measuring gingival index, bleeding index, pocket depth, and supra crestal tissue attachment level at the start of the study and after one and three months. Microbiological samples from periodontal pockets will also be used to assess levels using quantitative Polymerase Chain Reaction (qPCR) for relative abundance of Treponema denticola and Porphyromonas gingivalis bacteria related to periodontal disease.
- Conditions
- Stage III Periodontitis
- Being tested
- Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Scaling and root planing and topical application of active oxygen-releasing gel, Scaling and root planing
- Keywords
- Active oxygen releasing gel, Photodynamic therapy, Periodontitis, Scaling and Root Planing,
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laserProcedure or surgery
14 stage III periodontitis patients will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes then irrigating the targeted pocket using tolonium chloride will be stopped once the tolonium chloride solution will be observed at the free gingival margin of the pocket. After 60 seconds, irradiation inside the periodontal pocket with diode laser (635nm) for 200 mW, 30 seconds, energy density of 6 J/cm2, tip diameter of 400 µm, using continuous modes of irradiation, the laser fiber tip will be positioned parallel to the long axis of the tooth, move in a steady vertical inward and outward motion to ensure that the entire pocket will be adequately covered.
Scaling and root planing and topical application of active oxygen-releasing gelProcedure or surgery
14 patients with stage III periodontitis will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes.
Scaling and root planingProcedure or surgery
14 patients will undergo scaling and root planing(SRP) using ultrasonics and Gracey curettes.
| Study group | Role | What they receive |
|---|---|---|
| SRP+Active oxygen gel. | Experimental | Scaling and root planing(SRP)followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minute Receives: Procedure: Scaling and root planing and topical application of active oxygen-releasing gel; Procedure: Scaling and root planing |
| SRP+ Oxygen gel+Laser | Experimental | Scaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site." Receives: Procedure: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser; Procedure: Scaling and root planing and topical application of active oxygen-releasing gel; Procedure: Scaling and root planing |
| Scaling and root planing alone. | Active comparator | Scaling and root planing using ultrasonics and Gracey curettes. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gingival Index (MGI) score
non-invasive, visual clinical tool (0-4 scale)focuses on color, texture, and contour changes across facial, lingual, mesial, and distal surfaces of tooth ,modified gingival Scoring Criteria for MGI (0-4) higher scores indicate more severe gingival inflammation higher a worse clinical outcome.
0: Absence of inflammation (normal gingiva).
- Mild inflammation - slight change in color/texture in part of the marginal or papillary gingiva.
- Mild inflammation - slight change in color/texture in the entire marginal or papillary gingiva.
- Moderate inflammation - bright surface, erythema, edema, and/or hypertrophy of the marginal or papillary gingiva.
- Severe inflammation - severe erythema, edema, and/or marg
Measured: Before enrollment, and one and three months after enrollment
Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe
a clinical parameter measured by inserting a periodontal probe to the base of a gingival pocket.The probe is inserted parallel to the root surface and "walked" around the gingival sulcus, with bleeding assessed 30-60 seconds after probing.recorded as a percentage of positive bleeding sites out of the total sites probed (6 sites per tooth). A higher percentage of bleeding sites indicates increased gingival inflammation and a worse outcome.
Measured: Before enrollment, and one and three months after enrollment
Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe
measured in millimeters using Williams calibrated probe from the cemento-enamel junction to the bottom of the pocket .This measure reflects the extent of periodontal tissue destruction. Higher values in millimeters indicate greater attachment loss and a worse clinical condition.
Measured: Before enrollment, and one and three months after enrollment
Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe
Clinical measurement of the distance in millimeter from the gingival margin to the base of the periodontal pocket using Williams calibrated probe.Deeper pockets indicate more severe periodontal disease. Higher values represent a worse outcome.
Measured: Before enrollment, and one and three months after enrollment
Secondary outcomes (1)
Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR)
Sub-gingival dental plaque biofilm (before the intervention and one month after the intervention) will be collected using size 30 paper point after ensuring good isolation of the operating field. quantitative real time PCR will be performed using universal bacterial 16SrRNA gene primers and species-specific primers targeting the 16S rRNA genes of Treponema denticola (Td), and Porphyromonas gingivalis (Pg), to estimate the relative abundance of Td and Pg among total oral microbiota before and after treatment
Measured: Before enrollment and one month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start26 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III PeriodontitisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdelmawla, Alexandria University
- Investigators
- Mohey eldin Elrashidy, PhD,prof, Principal investigator, Faculty of Dentistry periodontology department Alexandria University,Egypt.Tarek Alsahry, Phd, Study director, Faculty of Dentistry periodontology department Alexandria University,Egypt.Aliaa Gamaleldin Aboulela, PhD, Study director, Microbiology Department ,Medical Research Institute Alexandria University,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368699
- Sponsor's protocol ID
- 1016-12/2024
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07368699
- Acronym / sponsor ID
- 1016-12/2024
- Conditions
- Stage III Periodontitis
- Keywords
- Active oxygen releasing gel, Photodynamic therapy, Periodontitis, Scaling and Root Planing,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 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.
Periodontitis is a serious gum disease that can damage the tissues supporting the teeth. The standard treatment is scaling and root planing of the teeth and roots. However, in some patients, this treatment alone may not fully control inflammation and harmful bacteria.
This study aims to evaluate whether adding an active oxygen-releasing gel, with or without photodynamic therapy, improves treatment outcomes in patients with stage III periodontitis. The oxygen-releasing gel is applied to the gums and releases oxygen, which may help reduce harmful bacteria. Photodynamic therapy uses a light source together with a special dye to target and destroy bacteria and improve gingival health.
In this randomized clinical trial, 42 patients with stage III periodontitis will be divided into three groups. One group will receive standard scaling and root planing (SRP) plus the oxygen-releasing gel. A second group will receive standard scaling and root planing (SRP)plus the gel and photodynamic therapy. The third group will receive standard scaling and root planing(SRP) only.
Gum health will be evaluated by measuring gingival index, bleeding index, pocket depth, and supra crestal tissue attachment level at the start of the study and after one and three months. Microbiological samples from periodontal pockets will also be used to assess levels using quantitative Polymerase Chain Reaction (qPCR) for relative abundance of Treponema denticola and Porphyromonas gingivalis bacteria related to periodontal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SRP+Active oxygen gel. | Experimental | Procedure: Scaling and root planing and topical application of active oxygen-releasing gel, Procedure: Scaling and root planingScaling and root planing(SRP)followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minute |
| SRP+ Oxygen gel+Laser | Experimental | Procedure: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Procedure: Scaling and root planing and topical application of active oxygen-releasing gel, Procedure: Scaling and root planingScaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site." |
| Scaling and root planing alone. | Active comparator | Procedure: Scaling and root planingScaling and root planing using ultrasonics and Gracey curettes. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with periodontal diagnosis of stage III periodontitis
- Patients with residual periodontal pocket depth ≥4 mm ,CAL≥ 5mm with bone loss extending to middle third of root and beyond in radiography
- Bleeding on probing at least four sites at base-line
- Patients who didn't receive periodontal treatment for a minimum of 3 months prior to the examination.
- Patients of both sexes aged ≥30 and ≤70 years
Key exclusion criteria (5 listed)
- Smokers or those with any other harmful habits such as pipe or vape smoking
- Patients with any systemic condition that will possibly affect the outcome of periodontal therapy i.e. (diabetic patients)
- Patients who have received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months
- Pregnant or lactating women
- Patients with parafunctional habits
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 |
|---|---|---|
| Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser14 stage III periodontitis patients will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes then irrigating the targeted pocket using tolonium chloride will be stopped once the tolonium chloride solution will be observed at the free gingival margin of the pocket. After 60 seconds, irradiation inside the periodontal pocket with diode laser (635nm) for 200 mW, 30 seconds, energy density of 6 J/cm2, tip diameter of 400 µm, using continuous modes of irradiation, the laser fiber tip will be positioned parallel to the long axis of the tooth, move in a steady vertical inward and outward motion to ensure that the entire pocket will be adequately covered. | Procedure or surgery | SRP+ Oxygen gel+Laser |
| Scaling and root planing and topical application of active oxygen-releasing gel14 patients with stage III periodontitis will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. | Procedure or surgery | SRP+ Oxygen gel+Laser, SRP+Active oxygen gel. |
| Scaling and root planing14 patients will undergo scaling and root planing(SRP) using ultrasonics and Gracey curettes. | Procedure or surgery | SRP+ Oxygen gel+Laser, SRP+Active oxygen gel., Scaling and root planing alone. |
Primary outcome
Modified Gingival Index (MGI) score
Time frame: Before enrollment, and one and three months after enrollment
non-invasive, visual clinical tool (0-4 scale)focuses on color, texture, and contour changes across facial, lingual, mesial, and distal surfaces of tooth ,modified gingival Scoring Criteria for MGI (0-4) higher scores indicate more severe gingival inflammation higher a worse clinical outcome. 0: Absence of inflammation (normal gingiva). 1. Mild inflammation - slight change in color/texture in part of the marginal or papillary gingiva. 2. Mild inflammation - slight change in color/texture in the entire marginal or papillary gingiva. 3. Moderate inflammation - bright surface, erythema, edema, and/or hypertrophy of the marginal or papillary gingiva. 4. Severe inflammation - severe erythema, edema, and/or marg
Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe
Time frame: Before enrollment, and one and three months after enrollment
a clinical parameter measured by inserting a periodontal probe to the base of a gingival pocket.The probe is inserted parallel to the root surface and "walked" around the gingival sulcus, with bleeding assessed 30-60 seconds after probing.recorded as a percentage of positive bleeding sites out of the total sites probed (6 sites per tooth). A higher percentage of bleeding sites indicates increased gingival inflammation and a worse outcome.
Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe
Time frame: Before enrollment, and one and three months after enrollment
measured in millimeters using Williams calibrated probe from the cemento-enamel junction to the bottom of the pocket .This measure reflects the extent of periodontal tissue destruction. Higher values in millimeters indicate greater attachment loss and a worse clinical condition.
Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe
Time frame: Before enrollment, and one and three months after enrollment
Clinical measurement of the distance in millimeter from the gingival margin to the base of the periodontal pocket using Williams calibrated probe.Deeper pockets indicate more severe periodontal disease. Higher values represent a worse outcome.
1 secondary outcome
Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR)
Time frame: Before enrollment and one month after enrollment
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 9 Oct 2026.
- 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.
Aliaa Gamaleldin Aboulela, PhD contact
Mohey eldin Elrashidy, PhD,prof principal investigator
Faculty of Dentistry periodontology department Alexandria University,Egypt.
Tarek Alsahry, Phd study director
Faculty of Dentistry periodontology department Alexandria University,Egypt.
Aliaa Gamaleldin Aboulela, PhD study director
Microbiology Department ,Medical Research Institute Alexandria University,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Scaling and root planing and topical application of active oxygen-releasing gel and Scaling and root planing in people with Stage III Periodontitis, run by Alexandria University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 9 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 Egypt. 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 Aya Abdelmawla, BDS (+201128192575, aia.abdelmoula.2019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Gingival Index (MGI) score (time frame: Before enrollment, and one and three months after enrollment). The study lists 4 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 9 Oct 2026.