| CTRI Number |
CTRI/2025/10/096124 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Silver or Not? The impact of nanoparticles dressings on Wound recovery and Patient experience following periodontal flap surgery |
|
Scientific Title of Study
|
Silver or Not? The impact of nanoparticles dressings on Wound recovery and Patient experience following periodontal flap surgery :A double blinded Randomised 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 |
Dr Ashutosh Dixit |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Department of dentistry, level 2 (C2). Room- Periodontics. Near veerbhadra colony. Pincode- 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9899818242 |
| Fax |
|
| Email |
dixitdrashutosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shambhavi |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Department of dentistry, level 2 (C2). Room- Periodontics. Near veerbhadra colony. Pincode- 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8789980178 |
| Fax |
|
| Email |
visit.shambhavi0423@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shambhavi |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Department of dentistry, level 2 (C2). Room- Periodontics. Near veerbhadra colony. Pincode- 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8789980178 |
| Fax |
|
| Email |
visit.shambhavi0423@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dean office level 1, AIIMS Rishikesh, near veerbhadra colony. Pincode-249203, Rishikesh, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Dean office level 1, AIIMS Rishikesh, near veerbhadra colony. Pincode-249203, Rishikesh, Uttarakhand |
| Type of Sponsor |
Government medical college |
|
|
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 Ashutosh dixit |
AIIMS Rishikesh |
AIIMS Rishikesh, Department of dentistry, level 2 (C2) near veerbhadra colony, Rishikesh
Dehradun
UTTARANCHAL |
9899818242
dixitdrashutosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: Z729||Problem related to lifestyle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coe-pak |
Coe-Pak™ (GC America Inc., USA) is a widely used non-eugenol periodontal dressing applied after periodontal surgeries to protect the wound, stabilize flaps, and reduce pain and bleeding. It offers good biocompatibility and ease of use without the irritation associated with eugenol-based dressings. However, it has limited antimicrobial activity and modest esthetics. Despite these drawbacks, Coe-Pak™ remains the most commonly used periodontal dressing for routine clinical applications. |
| Intervention |
Silver nanoparticle membrane (acticoat) with Coe pak |
Periodontal dressings incorporated silver nanoparticles (AgNPs), which are particles of silver smaller than 100 nm with potent antimicrobial, anti-inflammatory, and wound-healing properties.
ACTICOAT (Smith and Nephew Medical Limited), a silver nanoparticle-impregnated dressing. Research has shown that silver nanoparticles not only promote wound healing through their anti-inflammatory properties but also significantly reduce levels of pro-inflammatory markers. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 30-55 years
Good systemic condition
Non smokers
Chronic periodontitis subjects (with pocket depth more than or equal to 5mm), requiring periodontal flap surgery
|
|
| ExclusionCriteria |
| Details |
Poor oral hygiene (Plaque score and Bleeding on probing more than 25 precent)
Uncontrolled diabetes mellitus.
Immune diseases.
Heavy smokers
Bruxism.
History of allergy to silver
Presence of any active periodontal diseases, immunocompromised condition, and steroid medication.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Landry wound healing index |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Colony forming units(Microbilogical)
IQ ELISA (Biochemical VEGF marker)
VAS Score |
1 week |
|
|
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 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="2"
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
|
Periodontal dressings are commonly used after surgical procedures such as gingivectomy and flap surgeries to protect the wound, minimize postoperative pain and bleeding, prevent infection, and enhance patient comfort. Traditional zinc oxide–eugenol dressings, though effective, caused irritation and delayed healing, leading to the development of non-eugenol materials like Coe-Pak™. Despite its widespread use, Coe-Pak™ offers limited antimicrobial protection and suboptimal handling properties. Recent advances have introduced silver nanoparticle (AgNP)-based dressings such as ACTICOAT®, which possess strong antimicrobial and anti-inflammatory properties and promote faster soft-tissue repair. Incorporating ACTICOAT® with Coe-Pak™ may therefore improve gingival wound healing by combining mechanical protection with enhanced biologic activity. The present study aims to clinically, biochemically, and microbiologically compare early gingival wound healing and patient compliance following the placement of Coe-Pak™ alone versus a combination of ACTICOAT® and Coe-Pak™ after periodontal flap surgery. |