| CTRI Number |
CTRI/2025/07/090928 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gum Healing Study - Silver vs Turmeric Dressings |
|
Scientific Title of Study
|
Periodontal healing after Silver nanoparticle dressing vs Curcumin
dressing following the Periodontal flap surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddhant Bandopant Bhuyar |
| Designation |
Post Graduate Student |
| Affiliation |
Vidarbha Youth Welfare Society Dental College and Hospital |
| Address |
Room no. 16 , Department of Periodontology, Vidarbha Youth Welfare Society, Dental College and Hospital, Wadali
- Tapowan Road, Amravati Amravati MAHARASHTRA 444602 India
Amravati
MAHARASHTRA
444602
India
Amravati
MAHARASHTRA
444602
India |
| Phone |
7972618120 |
| Fax |
|
| Email |
sidbhuyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Gajendra Kedia |
| Designation |
Professor and PG Guide |
| Affiliation |
Vidarbha Youth Welfare Society Dental College and Hospital |
| Address |
Room no. 16 , Department of Periodontology, Vidarbha Youth Welfare Society
Dental College and Hospital, Wadali - Tapowan Road, Amravati
Amravati MAHARASHTRA 444602 India
Amravati
MAHARASHTRA
444602
India
Amravati
MAHARASHTRA
444602
India |
| Phone |
9370152435 |
| Fax |
|
| Email |
drsameerkedia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Gajendra Kedia |
| Designation |
Professor and PG Guide |
| Affiliation |
Vidarbha Youth Welfare Society Dental College and Hospital |
| Address |
Room no. 16 , Department of Periodontology, Vidarbha Youth Welfare Society
Dental College and Hospital, Wadali - Tapowan Road, Amravati
Amravati MAHARASHTRA 444602 India
Amravati
MAHARASHTRA
444602
India
MAHARASHTRA
444602
India |
| Phone |
9370152435 |
| Fax |
|
| Email |
drsameerkedia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Youth Welfare Societys Institute of Pharmacy and Research, Anjangao Bari Road,
Badnera - 444701 |
|
|
Primary Sponsor
|
| Name |
Dr Siddhant Bhuyar |
| Address |
Department of Periodontology, Vidarbha Youth Welfare Society
Dental College and Hospital, Wadali - Tapowan Road, Amravati
Amravati MAHARASHTRA 444602 India |
| 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 Siddhant Bhuyar |
Vidarbha Youth Welfare Society Dental College and Hospital |
Department of
Periodontology, Room
Number 16, First Floor.
Amravati
MAHARASHTRA
Amravati
MAHARASHTRA
Amravati
MAHARASHTRA |
7972618120
sidbhuyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - Vidarbha Youth Welfare Societys Dental College & Hospital, Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Silver Nanoparticle membrane application | (Procedure Reference: Silver Nanoparticle membrane application, Procedure details: Following Periodontal Flap Surgery, Silver Nanoparticle Membrane in applied after sutures are placed.)
(1) Medicine Name: Silver Nanoparticle membrane, Reference: A research article by Kanika Agrawal 2021, Route: Topical, Dosage Form: Lepa Gutika, Dose: 1(g), Frequency: sos, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Curcumin dressing application | (Procedure Reference: Curcumin dressing application, Procedure details: Following Periodontal Flap Surgery, Curcumin dressing is applied after sutures are placed. One dressing is applied for 7 days.)
(1) Medicine Name: Curcumin dressing, Reference: Curcumin dressing, Route: Topical, Dosage Form: Lepa Gutika, Dose: 1(g), Frequency: sos, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with severe Chronic periodontitis. |
|
| ExclusionCriteria |
| Details |
1. Patients in which Periodontal surgery is contraindicated.
2. Subjects with systemic conditions.
3. Former/ current smokers.
4. Pregnant & lactating subjects. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
i.Plaque Index
ii. Gingival Index.
iii. Wound Healing Index. |
7 days postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Following the Periodontal flap surgery, participants will be randomly assigned to two groups. Group A will receive Silver nanoparticles membrane dressing (Acticoat TM ) manufactured by Smith and Nephew, England and purchased from an online website. Group B will receive Curcumin dressing manufactured by Vidarbha Youth Welfare Society’s College of Pharmacy, Amravati following Periodontal flap surgery . The interventions will be standardized, ensuring consistency in the information provided. |