| CTRI Number |
CTRI/2025/07/090360 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Healing of Gingival Surgery With Two Different Dressings |
|
Scientific Title of Study
|
Comparison Of The Effect Of Silver Nanoparticles-impregnated Dressing V/S Non-eugenol Periodontal Dressing On Wound Healing After Gingivectomy -A Split Mouth Clinical -Biochemical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJyoti Verma |
| Designation |
PG Resident |
| Affiliation |
I.T.S Dental College,hospital and research centre |
| Address |
I.T.S Dental College,hospital and research centre 47,knowledge park III,greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09986814997 |
| Fax |
|
| Email |
VERMAJYOTI569@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGunjan Gupta |
| Designation |
Head of Department and professor |
| Affiliation |
I.T.S Dental College, Hospital and Research Centre |
| Address |
I.T.S Dental College, Hospital and Research Centre 47,Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9958543469 |
| Fax |
|
| Email |
hod.perio.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJyoti Verma |
| Designation |
PG Resident |
| Affiliation |
I.T.S Dental College, Hospital and Research Centre |
| Address |
Department of Periodontology ,Room no 8, 4th floor, I.T.S Dental College, Hospital and Research Centre 47,Knowledge park III, Greater Noida, Gautam Buddha Nagar
Department of Periodontology ,Room no 8,4th floor, I.T.S Dental College, Hospital and Research Centre 47, Knowledge park III, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09986814997 |
| Fax |
|
| Email |
vermajyoti569@gmail.com |
|
|
Source of Monetary or Material Support
|
| I.T.S Dental college,hospital and research centre47,knowledge park III greater noida 201310 |
|
|
Primary Sponsor
|
| Name |
Dr.Jyoti Verma |
| Address |
I.T.S Dental college,hospital and research centre47,knowledge park III greater noida 201310 |
| 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 Jyoti Verma |
I.T.S Dental College, Hospital And Research Centre |
Department Of Periodontology Room No 8 ,4th Floor, I.T.S Dental College, Hospital And Research Centre 47,Knowledge Park III Greater Noida 201310
Gautam Buddha Nagar
UTTAR PRADESH |
9986814997
vermajyoti569@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental college,hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Application of Non Eugenol periodontal dressing on Wound Healing following Gingivectomy |
Application of Non Eugenol periodontal dressing on Wound Healing following Gingivectomy Follow up Duration-Baseline,7th Day,21st Day |
| Intervention |
Application of Silver Nanoparticles- impregnated dressing With Non Eugenol periodontal dressing on Wound Healing following Gingivectomy |
Application of Silver Nanoparticles- impregnated dressing With Non Eugenol periodontal dressing on Wound Healing following Gingivectomy With Follow up Duration-Baseline,7th Day,21st Day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between 20-55years of age
2.Both genders included
3.Patient diagnosed with gingival enlargement
4.Cases indicated for gingivectomy in both upper and lower arches
5.Fibrotic type of gingival enlargement
|
|
| ExclusionCriteria |
| Details |
1.Tobacco chewers & Smokers.
2.Pregnant and lactating females.
3.Patients with history of uncontrolled systemic diseases affecting the periodontium.
4.Patients allergic to medications.
5.Those who have received surgical or non-surgical treatment 6 months prior.
6.Those undergoing antibiotic therapy or have had in last 6 months.
7.Post menopausal women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Gingival enlargement index ((Miller and Damm (1992)
2. Plaque Index (Silness and Loe 1964)
3. OHI-S Index (JohnC.Grenee&Jack R. Vermillion 1964)
4.Wound healing index (Landry et al)
5.VAS Score
|
Baseline,7th Day,21st Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/07/2025 |
| 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 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
|
Wound healing in periodontal surgery is a critical aspect of
post-operative care, influenced by various local and systemic factors. This
study evaluates and compares the effectiveness of silver nanoparticle
(AgNP)-impregnated dressings and conventional non-eugenol periodontal dressings
in enhancing wound healing following gingivectomy. Utilizing a split-mouth
design, twenty patients underwent gingivectomy on contralateral sides, with one
side treated with AgNP dressings and the other with non-eugenol dressings.
Clinical parameters including Wound Healing Index (WHI), Plaque Index (PI),
Oral Hygiene Index-Simplified (OHI-S), and pain assessment via Visual Analog
Scale (VAS) were recorded at baseline, day 7, and day 21. Biochemical analysis
of Fibroblast Growth Factor-1 (FGF-1) in saliva was conducted using ELISA. The
AgNP group showed significantly improved healing, reduced pain, better plaque
control, and increased FGF-1 levels. These findings suggest that
AgNP-impregnated dressings offer superior wound healing outcomes compared to
traditional dressings, highlighting their potential for broader application in
periodontal therapy |