CompletedEarly Phase 1

Assessment of Spirulina Gel Prepared By Different Extraction Methods as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis

Egypt75 participantsStarted 2025-03-10

Plain-language summary

I) Patients: the present study will be carried on periodontitis patients. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the ethical committee of Faculty of dentistry, Mansoura University. Groups: Group I (negative control): 15 periodontally healthy subjects . Group II (positive control): 15 patients will be treated with mechanical debridement only. Group III (study group A): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel extracted by phosphate buffered saline (PBS). Group IV (study group B): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. Group V (study group C): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by ethanol. In group III, IV and V extract of spirulina algae powder (Emtenan Health Shop,2019 © Egypt,TEL 16246) Periodontal evaluation will be performed for all patients at baseline and after three months including the following parameters: * Plaque index (PI). * Gingival index. * Probing pocket depth (PPD). * Clinical attachment level (CAL). Gingival crevicular fluid sampling. Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets. Immunological analysis of TNF-α in GCF

Who can participate

Age range

25 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
. Receiving periodontal therapy in past 6 month.
. Pregnant and lactating females.
. Vulnerable groups of patients (e.g handicapped patients and decisionally impaired individuals).
. Smoking.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

assess the clinical effectiveness of the locally delivered spirulina gel prepared by different pharmaceutical extraction methods as an adjunctive therapy to mechanical debridement in stage II grade B periodontitis.

Timeframe: 3months

Trial details

NCT IDNCT07647874

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-25

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