| CTRI Number |
CTRI/2024/06/068596 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Microbial assessment in different sealing materials in dental implants |
|
Scientific Title of Study
|
Microbial assessment and quantification following placement of different sealing materials at the screw abutment connection under loading conditions in dental implants: A double blind randomized controlled 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 Sarah Mariam |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be university dental college and hospital, Pune |
| Address |
Dept. of Periodontology, Room No 3
Bharati Vidyapeeth deeemed to be university dental college and hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9540068535 |
| Fax |
|
| Email |
sarah.mariam@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarah Mariam |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be university dental college and hospital, Pune |
| Address |
Dept of Periodontology, Room no 3
Bharati vidyapeeth(deemed to be university) dental college and hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9540068535 |
| Fax |
|
| Email |
sarah.mariam@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarah Mariam |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be university dental college and hospital, Pune |
| Address |
Dept of Periodontology, Room No 3
Bharati vidyapeeth (deemed to be university) dental college and hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9540068535 |
| Fax |
|
| Email |
sarah.mariam@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research , Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Sarah Mariam |
Bharati Vidyapeeth (deemed to be university) dental college and hospital , Pune |
Department of Periodontology, Room No 3.
Pune
MAHARASHTRA |
9540068535
sarah.mariam@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth Instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
POLYTETRAFLOUROETHYLENE POINTS |
It is hydrophobic and provides a low-cost solution.
Dose: 3-4 PTFE points
Frequency: once
Route of administration: orally placed in dental implants
Total duration : 03 months |
| Intervention |
temporary filling composite |
Intervention group will have Light-curing temporary filling composite - ReTemp LC Flow as sealing agent of implant abutment screw hole. This material has “shape memoryâ€, low shrinkage so causes less microleakage, is easy to remove by one whole portion with hand dental instrument. It is new material to be tested. Main product catalogue: Central Drug Standard Control Organization, Ministry of Health, Govt of India. MFG/MD/2023/000203.International organization for standardization ISO 13485
Dose: 5 ml of Re Temp LC flow
Frequency: once
Route of administration: orally placed in dental implants
Total duration : 03 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having edentulism / missing teeth coming to outpatient department of Bharati Vidyapeeth Deemed to be university dental college and hospital, Pune.
2. Healthy adult population above 18 years of age.
3. Patients who are willing to be part of the study and give consent for same. |
|
| ExclusionCriteria |
| Details |
1. Fully dentate patients.
2. Patients who are not willing to be part of study.
3. Patients having any uncontrolled systemic condition who cannot undergo implant surgical procedures, having history of smoking in the past one year. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bacterial genome count in sealing agents |
At time of implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Peri – implant health.
2.Survival of dental implants during course of study.
3.Failure rate of dental implants. 4.Technical complications: screw loosening, screw fracture, abutment fracture, loss of prosthesis 5.At present there is no defined consensus regarding the most suitable sealing material for use in implant abutment screw hole. Outcome of our study may help reduce this ambiguity.
6.The outcome is likely to provide additional information regarding peri-implant disease and bacterial cause of subsequent implant failure. |
03 months after loading |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/07/2024 |
| 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="3"
Months="1"
Days="1" |
|
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
|
Since microbes comprise the primary factor with regard to implant failure, determining specific microbial niches is of paramount importance and this study will help us find specific microbial niches (identification and quantification) which can exist with regard to different sealing agents placed in implant abutment screw hole. Also, swab will be taken around the implant fixture before placement of abutment as that will act as the baseline or oral flora |