| CTRI Number |
CTRI/2019/09/021340 [Registered on: 19/09/2019] Trial Registered Prospectively |
| Last Modified On: |
18/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Bone loss in implants. |
|
Scientific Title of Study
|
Comparison of Crestal Bone Loss and Papilla Fill after Conventional and Immediate Implant Placement: A 12 Month Clinical and Radiographic Prospective Study. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Akanksha Raj |
| Address |
Room no.4 , Department of Periodontology, Manipal college of Dental Sciences , Light House Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6362981528 |
| Fax |
|
| Email |
drakanksharaj0409@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Neetha J shetty |
| Address |
Room no.4 , Department of Periodontology, Manipal college of Dental Sciences , Light House Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880858025 |
| Fax |
|
| Email |
neetha.rajesh@manipal.edu |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Akanksha Raj |
| Address |
Room no.4 , Department of Periodontology, Manipal college of Dental Sciences , Light House Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6362981528 |
| Fax |
|
| Email |
drakanksharaj0409@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Akanksha Raj |
| Address |
Room no 4, MCODS, Mangaluru, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akanksha Raj |
Manipal college of Dental Sciences |
Room no 4, Department of Periodontics, Hampankatta
Dakshina Kannada
|
6362981528
drakanksharaj0409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Other Procedures |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age - 18 to 55 years.
systemically and periodontally healthy individuals.
non smokers, good oral hygiene, availability of follow up, healthy remaining dentition, adequate quality and quantity of bone.
Mandibular or maxillary/ anterior or posterior single missing tooth. |
|
| ExclusionCriteria |
| Details |
Pregnancy at the time of inclusion.
parafunctional habits.
aggressive periodontitis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Comparison of crestal bone loss and papilla fill. |
3 months, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified gingival index, Modified plaque index. |
baseline, 6 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
04/10/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Brief Summary
|
The Aim of the study is to compare the crestal bone loss and papilla fill in conventional and immediately placed implants after prosthesis placement. Baseline will be recorded at the time of prosthesis placement in both conventional as well as Immediate group. After 6 moths and 1 year of prosthesis placement, the amount of crestal bone loss and papilla fill be recorded with the help of radiographs and indices. Other clinical parameters will also be recorded like modified gingival index, Gingival biotype and modified plaque index. |
