| CTRI Number |
CTRI/2024/06/069247 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a clinical trial to study the effect of emdogain (enamel matrix derivative) material on fixation of implant to bone, gum health, bone level |
|
Scientific Title of Study
|
Comparative Evaluation Of Implant Stability, Gingival Soft Tissue And Marginal Bone Level In Emdogain Treated And Conventional Implants :Randomized Controlled 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 |
Dr Mitali Niras |
| Designation |
post graduate student |
| Affiliation |
K M Shah dental college and hospital |
| Address |
no 9 department of prosthodontic crown and bridge
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7350348314 |
| Fax |
|
| Email |
mitaliniras@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tamanna Chhabra |
| Designation |
Professor |
| Affiliation |
K M Shah dental college and hospital |
| Address |
no 9 department of prosthodontic crown and bridge
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8758868392 |
| Fax |
|
| Email |
drtamannachhabra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mitali Niras |
| Designation |
post graduate student |
| Affiliation |
K M Shah dental college and hospital |
| Address |
no 9 department of prosthodontic crown and bridge
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7350348314 |
| Fax |
|
| Email |
mitaliniras@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support from K M Shah dental college and hospital sumandeep vidyapeeth pipariya
waghodia vadodara gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Mitali Niras |
| Address |
no 9 department of prosthodontic crown and bridge
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara |
| 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 mitali niras |
k m shah dental college and hospital |
no 9 department of prosthodontic crown and bridge
K M Shah dental college and hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT |
7350348314
mitaliniras@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional implant |
without application of emdogain |
| Intervention |
emdogain treated implant |
emdogain is an enamel matrix derivative with amelogenin as main component and it comes in a syringe form and directly applied on the surface of implant before placement and one syringe is used for one implant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 age above 18 years
2 Able to provide consent
3 Patient needs implants in 2 areas in the same arch |
|
| ExclusionCriteria |
| Details |
1 Patients with medical history in which any dental intervention would be contraindicated
2 Patients with any local or systemic disease condition or medication that might compromise
health of the periodontium
3 Pregnant and lactating women
4 Current chemotherapy radiotherapy or drugs that interfere with study
5 Patients who are not willing to sign the consent form |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability and Gingival soft tissue and Marginal bone level |
Implant stability at baseline 3 months, 6 months and 12 months gingival soft tissue and marginal bone level at 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
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 - NO
|
|
Brief Summary
|
This is a randomized, double blind, controlled clinical study comparing and evaluating the implant stability with the help of Resonance frequency analysis and gingival soft tissue (plaque index, bleeding index, probing depth, pink esthetic score) with the help of plastic periodontal probe and marginal bone level with the help of IOPA in emdogain treated implants versus conventional implants. Emdogain is used to improve the soft and hard tissue healing. in this study emdogain is going to be coated on implant before placement of implant on one side of the arch and on the other side of the same arch conventional implant will be placed. participant consent form will be provided to the patients in the simplified language. The study would be conducted for 1 year in 15 patients in India. The primary outcome of this study such as Implant stability will be measured at baseline, 3 months, 6months and 12months and gingival soft tissue, marginal bone level will be measured at 3 months, 6months and 12months. results will be compared statistically. |