| CTRI Number |
CTRI/2019/07/020454 [Registered on: 31/07/2019] Trial Registered Prospectively |
| Last Modified On: |
25/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Silver membrane on wound healing after Gum surgery |
|
Scientific Title of Study
|
Effect of Nano crystalline Silver membrane on early wound healing after Periodontal surgery- A Comparative Randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanika Aggarwal |
| Designation |
Post graduate student |
| Affiliation |
Panjab University, Chandigarh |
| Address |
Dr Harvansh Singh Judge Institute of Dental sciences and hospital, Panjab University, Chandigarh, Department of Periodontics, Room Number 108
H. No 755, SECTOR 2, panchkula
Panchkula
HARYANA
134108
India |
| Phone |
9814347085 |
| Fax |
|
| Email |
link.kanika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head |
| Affiliation |
Panjab University, Chandigarh |
| Address |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, Chandigarh, Department of Periodontics, Room No 109
Chandigarh
CHANDIGARH
160014
India |
| Phone |
09888000444 |
| Fax |
|
| Email |
ashish@justice.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Aggarwal |
| Designation |
Post graduate student |
| Affiliation |
Panjab University, Chandigarh |
| Address |
Dr Harvansh Singh Judge Institute od Dental sciences and Hospital, Dept of Periodontics, Room No 108
H. No 755, SECTOR 2, panchkula
Panchkula
HARYANA
160014
India |
| Phone |
9814347085 |
| Fax |
|
| Email |
link.kanika@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/S. SMITH & NEPHEW MEDICAL LTD., UK having factory premises at M/S. NUCRYST PHARMACEUTICALS CORPORATIONS, CANADA |
|
|
Primary Sponsor
|
| Name |
Kanika Aggarwal |
| Address |
H No 755 Sector 2 Panchkula Haryana |
| 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 Kanika Aggarwal |
Dr Harvansh Singh Judge Institute of Dental sciences and hospital, Sector 25, Chandigarh, |
Department of Periodontics, Room No 108
Chandigarh
CHANDIGARH |
9814347085
link.kanika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Panjab University, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eugenol free dressing |
Consists of 2 pastes:
1. Base paste containing zinc oxide with added oils and gums, and lorothidol which is a fungicide related to hexachlorophene.
2. The catalyst paste containing coconut fatty acids thickened with colophony resin or rosin and chlorothymol. |
| Intervention |
Nanocrystalline silver membrane |
The silver delivery dressing is a 3 layer wound dressing
consisting of an absorbent rayon/polyester core laminated between an upper and lower layer of silver coated high density polyethylene mesh. The laminations are held in place with ultrasound welds. The silver coating, which consists of 0.25±0.4 mg silver per mg high-density polyethylene, is a binary allow of silver and oxygen with negligible contaminants. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of chronic periodontitis indicated for periodontal flap surgery
2.Non-smoking
3. Teeth vital or properly treated with root canal therapy
4. Absence of inadequate restorations.
5. Patients who give consent
6. Patients with minimum 20 teeth. |
|
| ExclusionCriteria |
| Details |
1. Patients chronically treated (i.e., 2 week or more) with any medication that affect periodontal status (i.e., antibiotics or non-steroidal anti-inflammatory drugs), with clinically significant or unstable organic diseases or compromised healing potential (i.e., connective tissue disorders or bone metabolic diseases)
2. Patients allergic to Silver
3. Pregnant women or lactating
4. Patients affected by active infectious diseases, immune-compromised, or taking steroid medications
5. Patients with less than 20 teeth
6. Patients who do not give consent |
|
|
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 Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical comparison of early wound healing parameters following periodontal surgery using nanocrystalline silver membrane |
Baseline, 7 days, 14 days and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation and comparison of total colony count of microbial flora beneath the nanocrystalline silver membrane and eugenol free dressing alone.
2.Evaluation and comparison of the immunological parameters |
baseline and 7 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
31/07/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized clinical interventional study to be performed in the Department of Periodontics on the patients suffering from Chronic Periodontitis indicated for Periodontal Flap surgery with a sample size of 42 subjects(21 in each group). The subjects will be divided into two groups. One group will receive a eugenol free periodontal dressing after the surgery and other group will receive nanocrystalline silver membrane below the eugenol free dressing. The clinical parameters of wound healing will be assessed at 7, 14 and 21 days post surgery using Healing Index by Landry, Turnbull and Howley .Secondary outcomes that will be measured are Total Colony Count below the dressings and measurement of a biomarker VEGF through ELISA, both at baseline and 7 days post surgery. The aim of the study is to assess wound healing capacity and anti-microbial effect of silver nanocrystalline membrane below the periodontal dressing given after the periodontal surgery. |