| CTRI Number |
CTRI/2024/07/071221 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Result of using a Nano crystalline Silver membrane on surgical site healing after dental Implant Placement surgery-A Clinical study |
|
Scientific Title of Study
|
Effect of Nano crystalline Silver membrane on early wound healing after Implant Placement surgery-A Randomized Clinical 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 |
Shreya |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Periodontics, Dr Harvansh Singh Judge Institute of Dental Sciences |
| Address |
Room No 108, Department of Periodontics, Dr Harvansh Singh Judge Institute of Dental Sciences
CHANDIGARH
160014
India |
| Phone |
7015685427 |
| Fax |
|
| Email |
goelshreya0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Department of Periodontics Dr. Harvansh Singh Judge Institute of
Dental Sciences and Hospital Sector 25,Panjab university
Chandigarh
CHANDIGARH
160025
India |
| Phone |
9888000444 |
| Fax |
|
| Email |
ajain.pu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital |
| Address |
Department of Periodontics Dr. Harvansh Singh Judge Institute of
Dental Sciences and Hospital Sector 25,Panjab university
Chandigarh
CHANDIGARH
160025
India |
| Phone |
9888000444 |
| Fax |
|
| Email |
ajain.pu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Harvansh Singh Judge Institute of Dental Sciences & Hospital |
| Self
|
|
|
Primary Sponsor
|
| Name |
Dr Shreya |
| Address |
Room No. 108, Department of Periodontics, Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital,Sector 25, Panjab University, Chandigarh , 160036 |
| 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 Shreya |
Dr.Harvansh Singh Judge Institute of Dental Sciences and Hospital |
Room No. 108, Department of Periodontics
Chandigarh
CHANDIGARH |
7015685427
goelshreya0001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Panjab University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No periodontal dressing and no silver nano crystalline membrane |
In our control group, neither the dressing nor the Silver Nano crystalline membrane will be placed at the surgical site .After implant placement, Closed wound site will be evaluated for clinical, microbiological and immunological markers without the placement of any periodontal dressing and silver nanocrystalline membrane. This is the conventional way of doing implant placement. |
| Intervention |
Periodontal dressing |
A non eugenol periodontal dressing is the intervention here. In our study ,after the implant placement, a non eugenol periodontal dressing or periodontal pack will be placed over the closed surgical wound site after implant placement surgery. These dressings serve as a protective bandage, holding the soft tissue in place and providing several benefits such as: Protection of Newly Formed Tissue ,minimize postoperative pain, infection, and hemorrhage, promoting a more favorable healing environment and act as a barrier and thus safeguarding the surgical site from any trauma. |
| Intervention |
Periodontal Dressing + Silver Nanocrystalline Silver Membrane |
A Non eugenol periodontal dressing along with a commercially available Silver Nanocrystalline membrane is the intervention here. When applied to wounds, dressings loaded with silver nanoparticles act as a
protective barrier against microorganisms, preventing secondary infections while creating an environment conducive to wound healing. Thus, silver nano crystalline membrane along with non eugenol periodontal dressing play a crucial role in preventing secondary infections and promoting faster wound healing. After the implant placement, A periodontal dressing along with silver nanocrystalline membrane will be applied over the closed surgical wound site after the implant placement surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Non-smokers (former smokers were included if they had not smoked within 6 months of
the study initiation),2.Presence of edentulous site in mouth that is indicated for implant surgery,3.Patients who give consent,
4. Patients with good general health with no other condition contraindicating routine dental
treatment and implant surgery
|
|
| 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 on Bisphosphonate therapy, Radiation therapy ,Chemotherapy
3. Patients allergic to Silver
4. Pregnant women or lactating
5. Patients affected by active infectious diseases, immune-compromised, or taking steroid
medications
6. Patients who do not give consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and clinically compare early wound healing parameters following
implant placement surgery using a nanocrystalline silver membrane. |
Healing Index by LANDRY et al, Modified Plaque Index for dental implants ( Mombelli et al,1987) and Modified Gingival Index (Loe,1967) at 7th,14th and 21st day post implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Colony Count of microbial flora and Immunological
marker (VEGF) in all the three groups |
AT baseline and 7th day post implant placement |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [goelshreya0001@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 16-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to assess the efficacy of a silver nanocrystalline membrane in single stage implant surgery by conducting a randomized controlled trial. 36 patients will be randomly assigned to receive either the silver nanocrystalline membrane with periodontal dressing (Group A) or only periodontal dressing (Group B) or No dressing and No silver nanocrystalline membrane (Group C). Clinical parameters including wound healing, Plaque index, Gingival Index, microbiological analysis, and immunological analysis will be evaluated. Surgical procedures will follow standard protocols, with assessments conducted pre- and post-implantation. Post-operative assessments will include collecting samples for microbiological and immunological analysis and evaluating post-operative early wound healing. The study parameters include clinical monitoring of soft tissue wounds, microbiological parameters comparing total colony counts, and immunological parameters assessing the level of Vascular Endothelial Growth Factor (VEGF) for wound healing. Clinical parameters including wound healing, Plaque index, Gingival Index will be evaluated at 7th,14th and 21st day post implant placement surgery. Microbiological analysis, and immunological analysis will be evaluated at baseline and 7th day post implant placement surgery. |