| CTRI Number |
CTRI/2024/05/067078 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check for the effect of implant sealant gel at implant abutment junction - a microiological study |
|
Scientific Title of Study
|
Evaluating the efficacy of implant sealant at implant abutment interface - a microbiological 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 |
Dr VEERENDRA NATH REDDY |
| Designation |
Professor |
| Affiliation |
Panineeya mahavidyala institute of dental sciences and research centre |
| Address |
Room no 101, Department of Periodontics, Panineeya
Mahavidyalaya Institute of Dental Sciences and
Research centre, Road no 5, Kamalanagar ,
Dilsukhnagar, Hyderabad
Hyderabad
TELANGANA
500060
India |
| Phone |
7386317946 |
| Fax |
|
| Email |
veerureddy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEERENDRA NATH REDDY |
| Designation |
Professor |
| Affiliation |
Panineeya mahavidyala institute of dental sciences and research centre |
| Address |
Room no 101, Department of Periodontics, Paninneya
Mahavidyalaya Institute of Dental sciences and
Research centre, Road no. 5, Kamalanagar ,
Dilsukhnagar.
TELANGANA
500060
India |
| Phone |
7386317946 |
| Fax |
|
| Email |
veerureddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shingade Vyshnavi |
| Designation |
post graduate |
| Affiliation |
Panineeya mahavidyala institute of dental sciences and research centre |
| Address |
ROOM NO 101, Department of Periodontics, Panineeya
Mahavidyalaya Institute of dental sciences and research centre, Road no. 5, Kamalanagar,
Dilsukhnagar.
Hyderabad
TELANGANA
500060
India |
| Phone |
7386317946 |
| Fax |
|
| Email |
shingadevyshnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyala institute of dental sciences and research centre,Road no.5,kamalanagr,Dilsukhnagar,Hyderabad,Telangana 500060 |
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyala institute of Dental sciences and research centre |
| Address |
Road no 5, Kamalanagar, Dilsukh nagar, Hyderabad. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shinagde vyshnavi |
Panineeya mahavidyalaya institute of dental sciences and research centre |
Department of Periodontics ,Room no 101,road no 5, Kamala
nagar, Dilsukh nagar,
Hyderabad.
Hyderabad
Hyderabad
TELANGANA |
7386317946
shingadevyshnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 2 Control group (10 patients):IMPLANT IS PLACED , WITHOUT IMPLANT SEALANT AT IMPLANT ABUDEMNT INTERFACE AT SECOND STAGE IMPALNT |
â–ª In this group, implant will be placed with proper surgical protocol in all the patients same as in test group, but without placement of antibacterial sealant at second stage. After one month swabs will be collected same as test group.
|
| Intervention |
GROUP 1 Test group (10 patients):IMPLANT SEALANT IS PLACED AT IMPLANT ABUDMENT INTERFACE AT SECOND STAGE IMPLANT |
â–ª In this group, implant will be placed with proper surgical protocol in all the patients. During second stage cover screw will be removed and abutment will be placed followed by application of implant sealant. After 1 month abutment will be removed and swabs will be taken from the implant well using sterile endodontic paper points. These samples at 6 months interval will be sent for culture and abutment will be screwed back to implants followed by final prosthesis placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients volunteering to participate in the study who have opted for implants as the choice of treatment.
2.Patients with good oral hygiene having missing tooth/teeth, with the adjacent teeth free from peri-apical pathology.
3.Adequate bone height and bone width.
4.Systemically healthy patient...
|
|
| ExclusionCriteria |
| Details |
â–ª Pregnant and lactating mothers.
â–ª Uncontrolled diabetes
â–ª Immunocompromised patients.
â–ª Having a history of jaw irradiation.
â–ª Patient with poor oral hygiene maintenance.
▪ Patient who doesn’t follow recall visits
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measurements of colony forming microorganims Prevotella intermedia, prorphymonas gingivalis,aggregatibacter aceticomitans |
Baseline,6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
28/05/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
▪ Dental implantology is the fastest developing technology in the practice of dentistry today which provides a natural looking appearance and has opened the door to the 21st century in dentistry. ▪ Implant superstructures are the superior part of a fixed or a removable prosthesis that includes the replacement teeth and associated gingival/alveolar structures. It has been postulated that a potential microscopic gap of 55–104 μ exists at the implant-abutment interface or the implant superstructure interface.▪ Oral micro-organisms have a diameter of 10 microns and can easily pass through this micro gap. This misfit may lead to microleakage of fluids and lead to bacterial growth which may cause loss of marginal bone and may lead to periimplantitis.. ▪ Thus, this study is formulated to check how effective is the presealing done at the implant interface by measuring colony forming units (CFU) of Preprohormones Gingivalis (PG), Prevotella intermedia(PI), Aggregetibacter actinomycetemcomitans (Aa). ROLE OF IMPLANT SEALANT IN CONTROLLING MICROLEAKAGE • Implant sealant provides a reliable seal and fills the hollow spaces in the implants . • It is a highly viscous silicon matrix which ensures a reliable sealing and prevents the ingression of organisms. • The principle of this material is that as the place is already occupied, there will be no nutrition for vital activity of organism to grow and develop. ▪ The addition of thymol ensures better Antifungal and antibacterial activity. ▪ The material does not get dried off, maintaining its viscosity, and preventing formation of new micro gaps. ▪ gaps. ▪ Thin silicone film effectively prevents adhesion of plaques on supporting implants. . The leakage without sealing agent was probably due to lack of complete wall to wall adaptation between abutment and implant. |