| CTRI Number |
CTRI/2025/08/092883 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between cranberry and brindle berry gel antibiotic medicine to reduce gum infection |
|
Scientific Title of Study
|
Comparative clinical evaluation of a local drug delivery of vaccinium macrocarpon and garcinia cambogia gel with tetracycline fibers for amelioration of 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 |
Riolla Sanchia Dsouza |
| Designation |
post graduate |
| Affiliation |
AJ Institute of dental sciences |
| Address |
AJ Institute of dental sciences kuntikana mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09449527309 |
| Fax |
|
| Email |
riolladsouza246@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjushree Kadam |
| Designation |
Professor |
| Affiliation |
AJ Institute of dental sciences |
| Address |
AJ Institute of dental sciences kuntikana mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
09448158952 |
| Fax |
|
| Email |
manjushreekadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjushree Kadam |
| Designation |
Professor |
| Affiliation |
AJ Institute of dental sciences |
| Address |
AJ Institute of dental sciences kuntikana mangalore
KARNATAKA
575004
India |
| Phone |
09448158952 |
| Fax |
|
| Email |
manjushreekadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| AJ Institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Riolla Sanchia Dsouza |
| Address |
AJ Institute of dental sciences kuntikana mangalore |
| 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 Riolla Sanchia Dsouza |
AJ Institute of dental sciences |
room no 3 dept of periodontology AJ Institute of dental sciences kuntikana mangalore
Dakshina Kannada
KARNATAKA |
09449527309
riolladsouza246@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJ Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polyberry gel made of vacinium macrocarpon and garcinia cambogia |
This is a poly berry herbal gel made with cranberry (vacinium macrocarpon) and brindle berry (garcinia cambogia) which will be used to evaluate reduction in localised periodontitis where a reduction in gingival pocket depth will be evaluated. the gel works on the basis of antioxidant capacity to the same which will help in reduction of bacterial load. |
| Comparator Agent |
tetracycline fibres |
antimicrobial agent used for local drug delivery in the form of fibres. gold standandard used in shallow gingival pockets for reduction in bacterial load via inhibition of bacterial load by bactericidal activity. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. patients willing to participate in the study
2. patients with chronic periodontitis with pocket depth of 4-6mm
3. patients willing to comply with multiple recall scedules |
|
| ExclusionCriteria |
| Details |
1. Patients who are unable to provide information or to co-operate with the dental examination.
2. Patients suffering from diabetes hypertension or under medication for any systemic disease
3. allergic patients
4. Pregnant/lactating patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the efficacy of local drug delivery of a polyberry gel formulated with phytoconstituent-rich extracts from both V. macrocarpon and G. cambogia. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in crp levels in saliva |
1 months |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Diseases of the oral cavity, especially of the gums, teeth, and the bone which holds the teeth together are associated with a high risk of health complications such as stroke, diabetes, and cardiovascular disease. Periodontitis is a group of inflammatory diseases that affect the connective tissue attachment and supporting bone around the teeth. The disease progresses with loss of collagen fibers and attachment to the root surface, apical migration of pocket epithelium formation of deepened periodontal pockets and resorption of alveolar bone leading to increased tooth mobility and subsequent tooth loss. Saliva, the oral cavity fluid is a rich source of biomarkers for periodontitis. Secretions from the major salivary glands have a large number of proteins which act as a diagnostic marker of periodontitis. The damaged periodontium stimulates synthesis of c reactive protein which reaches the saliva through gingival crevicular fluid and is an extremely sensitive marker in inflammation. Clinical diagnostic tools such as gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), and radiography provide insight into the severity of the disease. It has been noted that incorporation of systemic antimicrobial agents in conjugation with SRP can provide improved outcomes when compared with SRP alone in terms of decreasing probing pocket dept and improving clinical attachment level. a number of antimicrobial and chemotherapeutic agents have been used but are reported to have many side effects therefore more and more natural remedies are being scientifically validated and proven to be safer than synthetic drugs. Cranberry the native American fruit has recently come into limelight owning to its numerous beneficial effects on health popularly known for its nutrient and antioxidant qualities and is extensively marketed as a superfruit. Garcinia or Malabar tamarind native to south east Asia commonly used as food preservative flavoring agent or food bulking agent as a traditional remedy to treat numerous gut diseases. Studies have indicated activities such as ant obesity hypolipidemic and anti-cancer activity.[8] The beneficial properties of both the berries warrant their use in periodontics. The present study explores the protective activity of the poly berry gel containing phytoconstituents enriched extract of both the fruits in patients with periodontitis. |