Periodontitis Stage IINCT06699654
"Comparison of Spirulina Gels for Treating Stage II Grade B Periodontitis"
A study testing Spirulina Gel and Spirulina Nanoparticles Gel in people with Periodontitis Stage II, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis Stage II
- What is being tested?
- Spirulina Gel and Spirulina Nanoparticles Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2024to 1 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with good systemic health.
- Patients who can maintain good oral hygiene.
- Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·
- Any systemic disease that affects the periodontium. ·
- Pregnant, postmenopausal women. ·
- People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
- People who use mouth washes regularly ·
- Participation in other clinical trials.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Doctor Mohamed Samir Periodontal and Implantology Clinic
El-Sheikh Zayed City, Cairo Governorate, 12573
About this study
Official title: Comparative Study Between Spirulina Gel and Spirulina Nanoparticles Gel for Treatment of Stage II Grade B Periodontitis: Randomized Control Clinical Study with Radiological and Biochemical Assessment
This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.
- Conditions
- Periodontitis Stage II
- Being tested
- Placebo gel, Spirulina Gel, Spirulina Nanoparticles Gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelOther
A gel without active Spirulina components applied as a control intervention.
Spirulina GelDietary supplement
A conventional Spirulina gel formulation applied as a periodontal therapy.
Spirulina Nanoparticles GelDietary supplement
A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control group) | Placebo comparator | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket. Receives: Other: Placebo gel |
| Group II (experimental I) | Active comparator | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina gel instillation in the deepest selected periodontal pocket after drying the area around it. Receives: Dietary Supplement: Spirulina Gel |
| Group III (experimental II) | Experimental | Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina nanogel instillation in the deepest selected periodontal pocket after drying the area around it. Receives: Dietary Supplement: Spirulina Nanoparticles Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Probing Pocket Depth (PPD)
The mean reduction in probing pocket depth in millimeters (mm) at periodontal sites treated with Spirulina gel and Spirulina nanoparticles gel.
Measured: at baseline, 1 month , 3 months, 6 months
Secondary outcomes (2)
Radiographic Bone Density Improvement
Changes in alveolar bone density measured using radiographic imaging techniques.
Measured: at baseline and after 6 months
Biochemical Marker Levels
Reduction in inflammatory markers specifically Superoxide dismutase enzyme levels in gingival crevicular fluid.
Measured: Measured at baseline, 1 month ,3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start21 Oct 2024
- Primary completion24 Oct 2024
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Stage IIStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Model description
- Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Samir Mohamed Ahmed Algarf, Kafrelsheikh University
- Investigators
- Enas Elgendy, Prof.Dr, Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699654
- Sponsor's protocol ID
- KFSIRB200-68
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Spirulina Gel and Spirulina Nanoparticles Gel for Treatment of Stage II Grade B Periodontitis: Randomized Control Clinical Study with Radiological and Biochemical Assessment
- ClinicalTrials.gov ID
- NCT06699654
- Acronym / sponsor ID
- KFSIRB200-68
- Conditions
- Periodontitis Stage II
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 21 Nov 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.
This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Group I (control group) | Placebo comparator | Other: Placebo gelParticipants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket. |
| Group II (experimental I) | Active comparator | Dietary Supplement: Spirulina GelParticipants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina gel instillation in the deepest selected periodontal pocket after drying the area around it. |
| Group III (experimental II) | Experimental | Dietary Supplement: Spirulina Nanoparticles GelParticipants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina nanogel instillation in the deepest selected periodontal pocket after drying the area around it. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with good systemic health.
- Patients who can maintain good oral hygiene.
- Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·
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 |
|---|---|---|
| Placebo gelA gel without active Spirulina components applied as a control intervention. | Other | Group I (control group) |
| Spirulina GelA conventional Spirulina gel formulation applied as a periodontal therapy. | Dietary supplement | Group II (experimental I) |
| Spirulina Nanoparticles GelA novel Spirulina nanoparticles gel formulation applied as a periodontal therapy. | Dietary supplement | Group III (experimental II) |
Primary outcome
Reduction in Probing Pocket Depth (PPD)
Time frame: at baseline, 1 month , 3 months, 6 months
The mean reduction in probing pocket depth in millimeters (mm) at periodontal sites treated with Spirulina gel and Spirulina nanoparticles gel.
2 secondary outcomes
Radiographic Bone Density Improvement
Time frame: at baseline and after 6 months
Biochemical Marker Levels
Time frame: Measured at baseline, 1 month ,3 months, and 6 months
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 11 Feb 2025.
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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.
Enas Elgendy, Prof.Dr study director
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina Gel and Spirulina Nanoparticles Gel in people with Periodontitis Stage II, run by Kafrelsheikh 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 8 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
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?
Reduction in Probing Pocket Depth (PPD) (time frame: at baseline, 1 month , 3 months, 6 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 11 Feb 2025.