| CTRI Number |
CTRI/2026/01/100199 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patients with gum disease receiving nanoparticle infused gel and lycopene gel along with teeth cleaning procedure and its effect on salivary cortisol levels and gum disease parameters. |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of nanoparticle infused gel and lycopene gel as an adjunct to scaling and root planing on salivary cortisol levels at different time interval in stage-III periodontitis- a clinico-biochemical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana Jirafe |
| Designation |
PhD scholar |
| Affiliation |
PhD scholar |
| Address |
212,Department of Periodontology, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9923905017 |
| Fax |
|
| Email |
adisanju3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and HOD |
| Affiliation |
PhD guide |
| Address |
212, Department of Periodontology, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjana Jirafe |
| Designation |
PhD scholar |
| Affiliation |
PhD scholar |
| Address |
212, Department of Periodontology,
Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9923905017 |
| Fax |
|
| Email |
adisanju3@gmail.com |
|
|
Source of Monetary or Material Support
|
| infrastructural support: Government Dental College and Hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Sanjana Jirafe |
Government Dental College and Hospital, Nagpur |
Department of Periodontology
Nagpur
MAHARASHTRA |
9923905017
adisanju3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: lycopene gel, Reference: gel, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(mg), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 3 Months, Reference: , Route: , Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 3 Months, Reference: , Route: , Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Scaling and root planing alone | SRP alone | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Gold and silver nanoparticle infused gel, Reference: NA, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 5(ml), Frequency: sos, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 3 Months, Reference: NA, Route: , Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 3 Months, Reference: NA, Route: , Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with stage III periodontitis
2. Site selected having probing pocket depth of more than or equal to 6mm and Clinical attachment level of more than or equal to 5mm.
3. Age group 25 to 65 years. |
|
| ExclusionCriteria |
| Details |
1. Patients with medical disorders such as cardiovascular or renal disease, poorly controlled
diabetes, liver diseases, malignancy, and radiotherapy.
2. Patients with recent history or presence of acute or chronic infection.
3. Pregnant women or lactating mothers.
4. Inability of the persons to co-operate because of their physical or mental status or daily
routine.
5. Patients who has gone under any antibiotic therapy in previous 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate an effectiveness of gold and silver nanoparticles infused gel on salivary
cortisol levels.
2. To evaluate an effectiveness of lycopene gel on salivary cortisol levels.
3. To evaluate an effectiveness of SRP alone on salivary cortisol levels.
4. To compare effectiveness of gold and silver nanoparticles infused gel, lycopene gel and
SRP alone on salivary cortisol level |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate an effectiveness of gold & silver nanoparticles infused gel on Plaque Index,
Gingival Index, Probing Pocket Depth & Clinical Attachment Levels.
2. To evaluate an effectiveness of lycopene gel on Plaque Index, Gingival Index, Probing
Pocket Depth & Clinical Attachment Levels.
3. To evaluate an effectiveness of SRP alone on Plaque Index, Gingival Index, Probing
Pocket Depth & Clinical Attachment Levels.
4. To compare effectiveness of gold & silver nanoparticles infused gel, lycopene gel and
SRP alone on Plaque Index, Gingival Index, Probing Pocket Depth & Clinical
Attachment Levels. |
At baseline, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/02/2026 |
| 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="3"
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
|
Periodontitis is an inflammatory disease of periodontium which includes gum and bone loss. Salivary cortisol levels act as a biomarker for the periodontal disease. Considering
antioxidant properties of lycopene and gold and silver nanoparticles, this study will be designed
such as to evaluate and compare effectiveness of gold and silver nanoparticle infused gel and
lycopene gel as an adjunct to Scaling and Root Planing and Scaling and Root Planing alone on salivary cortisol levels in the treatment of
stage III periodontitis. |