Chronic PeriodontitisPhase 4NCT02886676
Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects
A Phase 4 study testing Spirulina capsules in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College.
Trial summary
Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease. It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Spirulina capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2016
- Phase
- Phase 4
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with CP (moderate and severe)as per CDC criteria 2007.
- Patients without any known systemic diseases.
Who cannot join
- Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
- Subjects who have undergone periodontal treatment within six months of inception of study.
- Tobacco habits in any form and alcoholics.
- Pregnant and lactating women.
About this study
Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.
It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis.
Read more
Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary antioxidants level in CP subjects.
Materials And Methods- The study was a randomized double-blind clinical and biochemical trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at baseline, 1 month \& 3 months.
- Conditions
- Chronic Periodontitis
- Being tested
- Spirulina capsules
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina capsulesDrug
Spirulina capsules 2gm daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Spirulina capsules and scaling & root planing | Experimental | Patients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month Receives: Drug: Spirulina capsules |
| Placebo capsules and scaling & root planing | Active comparator | Patients in test group will be provided with placebo capsules after meals for 1 month Receives: Drug: Spirulina capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superoxide dismutase (SOD)
Measured: 3 month
Malondialdehyde (MDA)
Measured: 3 month
Secondary outcomes (5)
plaque index
Measured: 3 month
Gingival bleeding index
Measured: 3 month
Sulcus bleeding index (SBI)
Measured: 3 month
Probing depth (PD)
Measured: 3 month
Clinical Attachment Level (CAL)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pradnya Rajendra Khatavkar, Tatyasaheb Kore Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886676
- Sponsor's protocol ID
- panu2511
- Status last verified
- Aug 2016
- First submitted
- 27 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects
- ClinicalTrials.gov ID
- NCT02886676
- Acronym / sponsor ID
- panu2511
- Conditions
- Chronic Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.
It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis.
Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary antioxidants level in CP subjects.
Materials And Methods- The study was a randomized double-blind clinical and biochemical trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at baseline, 1 month \& 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina capsules and scaling & root planing | Experimental | Drug: Spirulina capsulesPatients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month |
| Placebo capsules and scaling & root planing | Active comparator | Drug: Spirulina capsulesPatients in test group will be provided with placebo capsules after meals for 1 month |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with CP (moderate and severe)as per CDC criteria 2007.
- Patients without any known systemic diseases.
Key exclusion criteria (4 listed)
- Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
- Subjects who have undergone periodontal treatment within six months of inception of study.
- Tobacco habits in any form and alcoholics.
- Pregnant and lactating women.
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 capsulesSpirulina capsules 2gm daily for 1 month | Drug | Placebo capsules and scaling & root planing, Spirulina capsules and scaling & root planing |
Primary outcome
Superoxide dismutase (SOD)
Time frame: 3 month
Malondialdehyde (MDA)
Time frame: 3 month
5 secondary outcomes
plaque index
Time frame: 3 month
Gingival bleeding index
Time frame: 3 month
Sulcus bleeding index (SBI)
Time frame: 3 month
Probing depth (PD)
Time frame: 3 month
Clinical Attachment Level (CAL)
Time frame: 3 month
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 1 Sep 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spirulina capsules in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College.
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: finished, as of the sponsor's last update on 1 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Superoxide dismutase (SOD) (time frame: 3 month). 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 1 Sep 2016.