PeriodontitisNCT06016933
Effect of Spirulina on Periodontitis
A study testing spirulina gel and SRP of all teeth in people with Periodontitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- spirulina gel and SRP of all teeth
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 22 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis
The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.
Read the detailed description
In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.
- Conditions
- Periodontitis
- Being tested
- spirulina gel, SRP of all teeth
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirulina gelDrug
Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.
SRP of all teethProcedure or surgery
Patients received oral hygiene instructions and SRP of all teeth.
| Study group | Role | What they receive |
|---|---|---|
| oral hygiene instructions and SRP of all teeth plus placebo gel. | Placebo comparator | Not described Receives: Procedure: SRP of all teeth |
| oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel. | Active comparator | Not described Receives: Drug: spirulina gel; Procedure: SRP of all teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Clinical attachment level was measured at baseline, 1 and 3 months after gel application.
Measured: 3 months
Probing pocket depth
Probing pocket depth was measured at baseline, 1 and 3 months after gel application.
Measured: 3 months
Interleukin 6.
Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.
Measured: 3 months
Secondary outcomes (2)
Plaque Index
Plaque index was measured at baseline and at 1, and 3-months post treatment.
Measured: 3 months
Gingival index
Gingival index was measured at baseline and at 1, and 3-months post treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jul 2022
- Primary completion1 Mar 2023
- Study completion22 Jul 2023
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016933
- Sponsor's protocol ID
- 5
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis
- ClinicalTrials.gov ID
- NCT06016933
- Acronym / sponsor ID
- 5
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 30 Aug 2023 (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.
The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.
Detailed description
In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral hygiene instructions and SRP of all teeth plus placebo gel. | Placebo comparator | Procedure: SRP of all teeth |
| oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel. | Active comparator | Drug: spirulina gel, Procedure: SRP of all teeth |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.
Key exclusion criteria (5 listed)
- 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.
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 gelPatient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days. | Drug | oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel. |
| SRP of all teethPatients received oral hygiene instructions and SRP of all teeth. | Procedure or surgery | oral hygiene instructions and SRP of all teeth plus placebo gel., oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel. |
Primary outcome
Clinical attachment level
Time frame: 3 months
Clinical attachment level was measured at baseline, 1 and 3 months after gel application.
Probing pocket depth
Time frame: 3 months
Probing pocket depth was measured at baseline, 1 and 3 months after gel application.
Interleukin 6.
Time frame: 3 months
Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.
2 secondary outcomes
Plaque Index
Time frame: 3 months
Gingival index
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SRP of all teeth in people with Periodontitis, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 30 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical attachment level (time frame: 3 months). The study lists 3 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 30 Aug 2023.