| CTRI Number |
CTRI/2025/10/096544 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of deep teeth cleaning with and without spirulina gel in patients with moderate gum disease |
|
Scientific Title of Study
|
Comparative Evaluation Of Scaling And Root Planing With And Without 1 Point 2 Percentage Spirulina Gel In Management Of Stage 2 Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cheedella Anmisha |
| Designation |
Post graduate |
| Affiliation |
Sibar institue of dental sciences |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur.
2/2 Udyoganagar
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8885388699 |
| Fax |
|
| Email |
anmishach9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chaitanya Adurty |
| Designation |
Reader |
| Affiliation |
Sibar institue of dental sciences |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur,andhra pradesh,india
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur,andhra pradesh,india
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8142402848 |
| Fax |
|
| Email |
chaitanyaadurty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Cheedella Anmisha |
| Designation |
Post graduate |
| Affiliation |
Sibar institue of dental sciences |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur.
2/2 Udyoganagar
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8885388699 |
| Fax |
|
| Email |
anmishach9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur,andhra pradesh,india,522009 |
|
|
Primary Sponsor
|
| Name |
Cheedella Anmisha |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur,andhra pradesh,india,522009 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Cheedella Anmisha |
Sibar institute of dental sciences |
Room no 8, 2nd floor, department of periodontology, sibar institute of dental sciences, takkellapadu, Guntur,andhra pradesh,india,522009
Guntur
ANDHRA PRADESH |
8885388699
anmishach9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences, Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spirulina gel |
patients will receive scaling and root planning followed by spirulina gel application followed up for 3 months for clinical parameters |
| Comparator Agent |
without spirulin gel |
patients will receive scaling and root planning followed up for 3 months for clinical parameters |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 35-55 years
2.Subjects who are apparently healthy.
3.Presence of at least 20 teeth
4.Subjects with Stage two periodontitis
5.Subjects who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers.
2. Subjects who have history of drug allergy.
3. Subjects who are under antibiotic therapy.
4. Any form of tobacco consumption.
5.Periodontal treatment in last three months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Clinical attachment level |
Baseline and after three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of probing depth, sulcular bleeding index. |
Baseline and after three months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/11/2025 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group clinical trial comparing the efficacy of Scaling and Root Planing With and Without Spirulina Gel in Stage two Periodontitis patients. Spirulina platensis a cyanobacterium approved by the U.S. Food and Drug Administration, offers nutritional and health benefits. Its main components are phycocyanin and carotenoids also known as lipophylic antioxidants. Phycocyanin, a microalgae, well-known for its nutritional and medicinal benefits is utilized globally as a dietary supplement. Phycocyanin reduces oedema, histamine release, myeloperoxidase activity, levels of prostaglandin and leukotriene in the inflamed tissues. These antiinflammatory effects of Phycocyanin may be caused by its scavenging properties towards oxygen reactive species and its inhibitory effects on cyclooxygenase activity and on histamine release from mast cells.Spirulina gel application as an adjunct to SRP might be beneficial in wound healing by reducing oxidative stress and anti-inflammatory properties might reduce persistent inflammation in periodontal tissues.In one group of twenty patients were treated with scaling and root planning with spirulina gel and in other group of twenty patients were treated scaling and root planning alone and Primary and secondary outcomes will be measured at baseline and after 3 months |