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

NCT07647874 | Completed Early Phase 1 DMC

• 1 other identifier: M02020250M
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Periodontal Disease; Periodontitis Stage II; Periodontal Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1-Plaque index: Evaluates the presence of plaque in a dichotomous manner. Each buccal, lingual, mesial, and distal surface of all present teeth is recorded as positive if it presents soft accumulations at the dentogingival junction. 2-Bleeding on Probing : Recorded from all present teeth (excluding third molars) at four sites per tooth: mesial, distal, buccal, and lingual. BOP is assessed in a dichotomous manner, indicating the presence or absence of bleeding following gentle probing.3-Gingival index:score of 0 represents normal gingiva score of 1 mild inflammation score of 2 moderate inflammation score of 3 severe inflammation • 4-Probing pocket depth:It is defined as the distance, measured in millimeters, from the free gingival margin to the base of the gingival sulcus.5-• Clinical attachment level:the distance in millimeters from the cementoenamel junction to the base of the periodontal pocket.

  3months

Secondary Outcomes (1)

• assess the impact of the locally delivered spirulina gel prepared by different pharmaceutical extraction methods as an adjunctive therapy to mechanical debridement on the GCF level of TNF-α in stage II grade B periodontitis.

  3 months

Study Arms (5)

negative control periodontally healthy subjects

NO INTERVENTION

periodontally healthy subjects no intervention

positive control

EXPERIMENTAL

patients will be treated with mechanical debridement only.

Other: Mechanical debridement will be performed for 15 stage II periodontitis patient

study group A

EXPERIMENTAL

patients will be treated with mechanical debridement followed by delivery of spirulina gel extracted by phosphate buffered saline (PBS).

Drug: spirulina gel extracted by phosphate buffered saline (PBS).

study group B

EXPERIMENTAL

patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.

Drug: spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.

study group C

EXPERIMENTAL

patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by ethanol.

Drug: spirulina gel exracted by ethanol.

Interventions

Mechanical debridement will be performed for 15 stage II periodontitis patient OTHER

Mechanical debridement will be performed for 15 stage II periodontitis patient

positive control

spirulina gel extracted by phosphate buffered saline (PBS). DRUG

15 patients will be treated with mechanical debridement followed by delivery of spirulina gel extracted by phosphate buffered saline (PBS).

study group A

spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. DRUG

15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution.

study group B

spirulina gel exracted by ethanol. DRUG

15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by ethanol

study group C

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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).
• \. Minimum of 20 remaining teeth. 3. Age range (25 - 50) years. 4. Good compliance with the plaque control instructions following initial therapy.
• \. Availability for follow up and maintenance program.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 00000, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

Calcium Chloride

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Faisal Mohammed Alsharif, Bachelor's degree

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's degree, Faculty of dentistry, Umm Alqura University, Saudi Arabia

Model Details: this is a retrospective interventional study

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start: March 10, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 25, 2026
• Last Updated: June 15, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)