| CTRI Number |
CTRI/2021/02/030881 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
09/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Relative assessment of the level of bone loss in two types of short dental implants after prosthetic rehabilitation |
|
Scientific Title of Study
|
Comparative evaluation of post prosthetic rehabilitation crestal bone loss in two variants of short dental implants- an in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debasis Tripathy |
| Designation |
MDS Student |
| Affiliation |
Saraswati Dental College, lucknow, Uttar Pradesh |
| Address |
Dr.Debasis Tripathy,PG/MDS Student,Department of Prosthodontics, Room no. 102, Saraswati Dental College and Hospital,Tiwari Ganj,Faizabad Road,Chinhat,Lucknow,Uttar Pradesh, PIN- 226028
Dr.Debasis Tripathy,PG/MDS Student,Department of Prosthodontics, Room no. 102, Saraswati Dental College and Hospital,Tiwari Ganj,Faizabad Road,Chinhat,Lucknow,Uttar Pradesh, PIN- 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
9777712568 |
| Fax |
|
| Email |
debasis4777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Chopra |
| Designation |
Reader |
| Affiliation |
Saraswati Dental College, lucknow, Uttar Pradesh |
| Address |
Dr Devendra Chopra, Reader, Department of Prosthodontics, Room no.101, Saraswati Dental College and Hospital, Tiwari Ganj, Faizabad Road, Chinhat, Lucknow, Uttar Pradesh, PIN- 226028
Dr Devendra Chopra, Reader, Department of Prosthodontics, Room no.101, Saraswati Dental College and Hospital, Tiwari Ganj, Faizabad Road, Chinhat, Lucknow, Uttar Pradesh, PIN- 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
9045207899 |
| Fax |
|
| Email |
drdevendra45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debasis Tripathy |
| Designation |
MDS Student |
| Affiliation |
Saraswati Dental College, lucknow, Uttar Pradesh |
| Address |
Dr.Debasis Tripathy,PG/MDS Student,Department of Prosthodontics,Room no.102, Saraswati Dental College and Hospital,Tiwari Ganj,Faizabad Road,Chinhat,Lucknow,Uttar Pradesh, PIN- 226028
Dr.Debasis Tripathy,PG/MDS Student,Department of Prosthodontics, Room no. 102, Saraswati Dental College and Hospital,Tiwari Ganj,Faizabad Road,Chinhat,Lucknow,Uttar Pradesh, PIN- 226028
Lucknow
UTTAR PRADESH
226028
India |
| Phone |
9777712568 |
| Fax |
|
| Email |
debasis4777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saraswati Dental College and Hospital,Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Debasis Tripathy |
| Address |
Dr Debasis Tripathy, PG student, Department of Prosthodontics, Saraswati Dental College,Lucknow, Uttar Pradesh, PIN- 226028 |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Debasis Tripathy |
Saraswati Dental College and Hospital, Lucknow, Uttar Pradesh |
Department of Prosthodontics,Room no.102, Saraswati Dental College and Hospital, Tiwari Ganj, Faizabad Road, Chinhat, lucknow, Uttar Pradesh, PIN- 226028
Lucknow
UTTAR PRADESH |
9777712568
debasis4777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, Saraswati Dental College and Hospital, Lucknow |
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 |
Not applicable |
Not applicable |
| Intervention |
Short Dental Implants |
After post prosthetic rehabilitation of short dental implants in patients, CBCT is done and crestal bone loss is assessed radiographically at baseline. Again after a gap of 3 months and 6 months, crestal bone loss is assessed again through CBCT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are 18 years of age or older.
Single missing tooth in posterior region of any of the dental arches.
Residual bone height ranging from 9-10 mm from the inferior dental canal.
At least 3 months of healing post extraction.
Natural tooth adjacent to the edentulous space which needs to be free from any pathology.
Presence of opposing natural teeth or prostheses. |
|
| ExclusionCriteria |
| Details |
Presence of untreated periodontal disease and caries.
Patients with a history of systemic disorders.
Patients with compromised residual alveolar ridges. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of crestal bone loss in the two variants short dental implants after prosthetic rehabilitation.
2. To determine which variant of short dental implant is better between the two ? |
Three time points viz-
1. Baseline
2. After 3 months of post prosthetic rehabilitation
3. After 6 months of post prosthetic rehabilitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the survival and success rate of short dental implants. |
Three time points same as primary outcome time points |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2021 |
| Date of Study Completion (India) |
07/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Short dental implants have become a viable option for the rehabilitation of atrophic alveolar ridges in the present day scenario. The aim of this study is- to determine which variant of short dental implant will have minimum crestal bone loss after prosthetic rehabilitation. The objective of this study is- to compare and evaluate post prosthetic rehabilitation crestal bone loss in two variants of short dental implants. |