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Completed
NCT07647874
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
Conditions: Periodontal Disease, Periodontitis Stage II, Periodontal Therapy
Sex: All
Ages: 25 Years – 50 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 75
Sponsor: Mansoura University
Location: Mansoura University Faculty of Dentistry Al Mansurah Dakahlia Governorate
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
Eligibility Criteria
Inclusion Criteria:
* 1\. Patients with Stage II Periodontitis grade B periodontitis (horizontal bone loss with maximum probing depth ≤ 5 mm and with 3-4 mm clinical attachment loss).
2\. Minimum of 20 remaining teeth. 3. Age range (25 - 50) years. 4. Good compliance with the plaque control instructions following initial therapy.
5\. Availability for follow up and maintenance program.
Exclusion Criteria:
1. Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
2. Receiving periodontal therapy in past 6 month.
3. Pregnant and lactating females.
4. Vulnerable groups of patients (e.g handicapped patients and decisionally impaired individuals).
5. Smoking.
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Source: ClinicalTrials.gov (NCT07647874). StuddyBuddy aggregates publicly available trial information.