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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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