PeriodontitisnonNCT07893587
Spirulina Gel in the Treatment of Periodontitis
A study testing spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. and conventional scaling and root planing in people with Periodontitis and Periodontitis Stage II, run by Misr University for Science and Technology.
Trial summary
This randomized clinical trial aims to evaluate the clinical and immunological effects of locally delivered Spirulina gel as an adjunct to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Periodontitis, Periodontitis Stage II
- What is being tested?
- spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. and conventional scaling and root planing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with stage II periodontitis, grade B
- Ability to maintain good oral hygiene as evidenced in recall visits
Who cannot join
- A smoking patient with more than 10 cigarettes.
- Pregnant and lactating patients.
- Patients with systemic conditions that could affect the outcome of periodontal therapy.
- Previous periodontal therapy in the last 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Radwa Mohamed Elsherif, Associate Professor contact
About this study
Official title: Effect of Spirulina Gel on Clinical Periodontal Parameters and Gingival Crevicular Fluid Interleukin-1β and TNF-α Levels in Patients With Stage II, Grade B Periodontitis
This randomized clinical trial aims to evaluate the clinical and immunological effects of locally delivered Spirulina gel as an adjunct to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. The study will include 20 male and female participants aged 25-40 years who will be randomly allocated into two groups.
The main questions are whether the addition of Spirulina gel to SRP improves periodontal clinical parameters, particularly probing pocket depth (PPD) and clinical attachment level (CAL), and whether it reduces the levels of interleukin-1β (IL-1β) and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF).
Read more
Participants in Group A will receive SRP alone, while participants in Group B will receive SRP followed by local application of Spirulina gel into selected periodontal pockets. All participants will undergo periodontal assessments at baseline and 6 months after treatment. Clinical evaluations will include plaque index, gingival index, PPD, and CAL. GCF samples will be collected at baseline, 15 days and 6 months, analyzed using enzyme-linked immunosorbent assay (ELISA) to measure IL-1β and TNF-α levels.
The findings will help determine whether adjunctive local application of Spirulina gel provides additional clinical and immunological benefits compared with SRP alone in the management of Stage II, Grade B periodontitis.
- Conditions
- Periodontitis, Periodontitis Stage II
- Being tested
- spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution., conventional scaling and root planing
- Keywords
- periodontitis, spirulina gel, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.Other
local application of spirulina gel into the periodontal pockets
conventional scaling and root planingOther
conventional scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal therapy approach including scaling and root planing. | Active comparator | Non-surgical periodontal therapy approach including scaling and root planing. Receives: Other: conventional scaling and root planing |
| spirulina application into the periodontal pocket after non-surgical periodontal therapy | Experimental | local application of spirulina gel into the periodontal pocket Receives: Other: spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.; Other: conventional scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level
Assessment of Clinical attachment level from Cemento-enamel junction to the base of periodontal pocket
Measured: baseline and 6 months
Probing depth
Assessment of probing depth from marginal gingiva to the base of periodontal pocket
Measured: baseline and 6 months
Secondary outcomes (3)
Plaque index
assessment amount of plaque on tooth surface
Measured: baseline and 6 months
Gingival index
assessment of gingival inflammation
Measured: baseline and 6 months
Assessment of tumor necrosis factor alpha (TNF-alpha) and interleukin-1 (IL-1) from
Assessment of tumor necrosis factor alpha (TNF-alpha) and interleukin-1β (IL-1β) from gingival crevicular fluid using filter paper - assessment by ELISA
Measured: baseline, 15 days 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 posted26 Oct 2026
- Study start30 Oct 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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Mohamed, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893587
- Sponsor's protocol ID
- Spirulina 123
- Acronym
- non
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spirulina Gel on Clinical Periodontal Parameters and Gingival Crevicular Fluid Interleukin-1β and TNF-α Levels in Patients With Stage II, Grade B Periodontitis
- ClinicalTrials.gov ID
- NCT07893587
- Acronym / sponsor ID
- non / Spirulina 123
- Conditions
- Periodontitis, Periodontitis Stage II
- Keywords
- periodontitis, spirulina gel, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Oct 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 randomized clinical trial aims to evaluate the clinical and immunological effects of locally delivered Spirulina gel as an adjunct to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. The study will include 20 male and female participants aged 25-40 years who will be randomly allocated into two groups.
The main questions are whether the addition of Spirulina gel to SRP improves periodontal clinical parameters, particularly probing pocket depth (PPD) and clinical attachment level (CAL), and whether it reduces the levels of interleukin-1β (IL-1β) and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF).
Participants in Group A will receive SRP alone, while participants in Group B will receive SRP followed by local application of Spirulina gel into selected periodontal pockets. All participants will undergo periodontal assessments at baseline and 6 months after treatment. Clinical evaluations will include plaque index, gingival index, PPD, and CAL. GCF samples will be collected at baseline, 15 days and 6 months, analyzed using enzyme-linked immunosorbent assay (ELISA) to measure IL-1β and TNF-α levels.
The findings will help determine whether adjunctive local application of Spirulina gel provides additional clinical and immunological benefits compared with SRP alone in the management of Stage II, Grade B periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal therapy approach including scaling and root planing. | Active comparator | Other: conventional scaling and root planingNon-surgical periodontal therapy approach including scaling and root planing. |
| spirulina application into the periodontal pocket after non-surgical periodontal therapy | Experimental | Other: spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution., Other: conventional scaling and root planinglocal application of spirulina gel into the periodontal pocket |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with stage II periodontitis, grade B
- Ability to maintain good oral hygiene as evidenced in recall visits
Key exclusion criteria (4 listed)
- A smoking patient with more than 10 cigarettes.
- Pregnant and lactating patients.
- Patients with systemic conditions that could affect the outcome of periodontal therapy.
- Previous periodontal therapy in the last 6 months.
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 |
|---|---|---|
| spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.local application of spirulina gel into the periodontal pockets | Other | spirulina application into the periodontal pocket after non-surgical periodontal therapy |
| conventional scaling and root planingconventional scaling and root planing | Other | Non-surgical periodontal therapy approach including scaling and root planing., spirulina application into the periodontal pocket after non-surgical periodontal therapy |
Primary outcome
clinical attachment level
Time frame: baseline and 6 months
Assessment of Clinical attachment level from Cemento-enamel junction to the base of periodontal pocket
Probing depth
Time frame: baseline and 6 months
Assessment of probing depth from marginal gingiva to the base of periodontal pocket
3 secondary outcomes
Plaque index
Time frame: baseline and 6 months
Gingival index
Time frame: baseline and 6 months
Assessment of tumor necrosis factor alpha (TNF-alpha) and interleukin-1 (IL-1) from
Time frame: baseline, 15 days 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 27 Oct 2026.
- 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.
Radwa Mohamed Elsherif, Associate Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. and conventional scaling and root planing in people with Periodontitis and Periodontitis Stage II, run by Misr University for Science and Technology.
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 2 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
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 Radwa Mohamed Elsherif, Associate Professor (radwa.mohamed@must.edu.eg ext. 01007800542, radwa.mohamed@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment level (time frame: baseline and 6 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 27 Oct 2026.