| CTRI Number |
CTRI/2025/09/095179 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing how cinnamon gel and aloe vera gel help reduce gum inflammation and plaque in people with gum disease. |
|
Scientific Title of Study
|
A comparative study on the anti-inflammatory & anti-plaque effect of Cinnamomum gel & aloe vera gel in gingivitis: A randomized clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Tejaswini |
| Designation |
PG student |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences
Room Number 3
Department of periodontics and Implantology
Chinnaoutpalli
Gannavaram
Chinnaoutpalli Krishna ANDHRA PRADESH 521286 India |
| Phone |
9014726887 |
| Fax |
|
| Email |
tejaswini07n@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Suneetha |
| Designation |
Professor |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences
Room Number 3
Department of periodontics and Implantology
Chinnaoutpalli
Gannavaram Chinnaoutpalli Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
konerusuneetha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Suneetha |
| Designation |
Professor |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences
Room Number 3
Department of periodontics and Implantology
Chinnaoutpalli
Gannavaram Chinnaoutpalli Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
konerusuneetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs. Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
N Tejaswini |
| Address |
Drs. Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences, Chinnaoutpally, Gannavaram Mandal, Krishna District, Andhrapradesh, PIN: 521101 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K Suneetha |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences
room no. 3
department of Periodontics & Implantology
Chinnaoutpalli
Gannnavaram Krishna ANDHRA PRADESH |
09290574051
konerusuneetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingivitis |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aloe vera gel |
Aloe vera gel is prepared by carefully extracting the inner clear mucilaginous gel from fresh Aloe barbadensis Miller leaves after washing and peeling away the outer rind, this raw gel is then filtered to remove fibrous material and mixed with gelling agent Carbopol to achieve the gel consistency. Additional ingredients such as pH adjusters are added to enhance stability, texture, and biocompatibility, and the final homogeneous gel is neutralized to a pH around 7.5 before being packaged in sterile containers for use. This formulation retains the bioactive components responsible for Aloe vera’s anti-inflammatory, antimicrobial, and wound-healing properties, making it well-suited for topical application in oral health care, including treatment of gingivitis and plaque control |
| Intervention |
cinnamon gel |
Cinnamomum gel [commercially available] |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 50 years diagnosed with plaque-induced gingivitis, having at least 20 natural teeth |
|
| ExclusionCriteria |
| Details |
Systemic illnesses, smokers, pregnant/lactating women, recent use of antibiotics or anti-inflammatory drugs, periodontitis, or ongoing periodontal treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival Index
plaque index
bleeding on probing |
baseline
7th day
14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bleeding on probing |
base line
14th day
|
| plaque index |
base line,
7th day,
14th day |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| Date of Study Completion (India) |
13/02/2026 |
| Date of First Enrollment (Global) |
06/10/2025 |
| Date of Study Completion (Global) |
13/02/2026 |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gingivitis is a reversible, plaque-induced inflammatory disease of gingival tissues and represents the initial stage of periodontal disease. It is primarily induced by dental plaque biofilm, which harbours pathogenic microorganisms that trigger an inflammatory response in the gingival tissues. The clinical features of gingivitis include redness, swelling and bleeding on probing. If left untreated, gingivitis can progress to periodontitis, leading to irreversible loss of supporting structures of the teeth and eventual tooth loss. Conventional management of gingivitis includes mechanical plaque control through toothbrushing, flossing, using interdental aids, and professional scaling. In addition, chemical agents such as chlorhexidine mouthwash are often prescribed as adjuncts for their antibacterial and plaque-inhibitory properties. However, long-term use of synthetic agents is associated with undesirable side effects, including tooth staining, altered taste sensation, and mucosal irritation. These limitations have encouraged the search for safer, natural alternatives that are well-tolerated, effective, and easily available. Herbal medicine has gained increasing attention in dentistry due to its antimicrobial, antioxidant, and anti-inflammatory properties. Among these, Cinnamomum (cinnamon) and Aloe vera stand out as promising agents. Cinnamomum contains bioactive compounds such as cinnamaldehyde and eugenol, which exhibit strong antibacterial, antifungal, and anti-inflammatory effects. These compounds may help in reducing plaque accumulation and controlling gingival inflammation. Aloe vera, on the other hand, has been traditionally used for wound healing and has demonstrated antimicrobial, anti-inflammatory, and soothing effects in various oral conditions. Its gel form is biocompatible, easy to apply, and provides a protective barrier on gingival tissues. Despite their potential benefits, very few clinical studies have directly compared the efficacy of Cinnamomum gel and Aloe vera gel in the management of gingivitis. Understanding their comparative effectiveness will provide valuable insights into evidence-based use of herbal products in dentistry. Hence, the present randomized clinical trial is designed to evaluate and compare the anti-inflammatory and anti-plaque effects of Cinnamomum gel and Aloe vera gel in patients with gingivitis. This study aims to determine whether these natural agents can serve as safe, effective alternatives or adjuncts to conventional gingivitis therapy. |