| CTRI Number |
CTRI/2024/11/076940 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Implant macrodesigns and its effect on crestal bone loss: A case report |
|
Scientific Title of Study
|
Comparative Evaluation Of Crestal Bone Loss Around
Implants Of Two Different Thread Designs-Buttress And VShaped :A Clinico-Radiographic CBCT 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 Charvi Ajay Kundu |
| Designation |
Post Graduate |
| Affiliation |
Subharti Dental College |
| Address |
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8160670838 |
| Fax |
|
| Email |
charvikundu44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Kaushik |
| Designation |
HOD of Periodontology |
| Affiliation |
Subharti Dental College |
| Address |
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9759444434 |
| Fax |
|
| Email |
drmayurkaushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charvi Kundu |
| Designation |
Post Graduate |
| Affiliation |
Subharti Dental College |
| Address |
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Department of Periodontology, Ground Floor Room Number 2, Subharti Dental College and hospital,Swami Vivekanand Subharti University,MEERUT,250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8160670838 |
| Fax |
|
| Email |
charvikundu44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Charvi Kundu |
| Address |
Subharti Dental College and Hospital Delhi Haridwar Bypass road NH58 Meerut 250005 |
| Type of Sponsor |
Other [] |
|
|
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 CHARVI AJAY LUNDU |
SUBHARTI DENTAL COLLEGE AND HOSPITAL |
DEPT OF PERIODONTOLOGY,SUBHARTI DENTAL COLLEGE AND HOSPITAL SWAMI VIVEKANAND SUBHARTI UNIVERSITY NH-58 DELHI HARIDWAR BYPASS ROAD MEERUT UTTAR PRADESH
Meerut
UTTAR PRADESH |
8160670838
charvikundu44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY 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 |
| Intervention |
10 patients were selected with buttress thread design |
A pre-operative immediate post-operative and 9 months RVG after implant placement
A preoperative and 9 months CBCT to assess the bone changes around implant |
| Comparator Agent |
10 patients were selected with VSHAPED thread design. |
A pre-operative and 9 months CBCT to assess the bone changes around implants.
Pre-operative,immediate post-operative and 9 months RVG after implant placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-50 years.
2. Patients having single missing tooth with an adequate width and height of edentulous space available for placement of implant.
3. Edentulous sites in mandibular and maxillary arches.
4. Adjacent teeth intact; restored with functionally & esthetically good restorations; restored with prosthesis precluding the addition of the missing tooth.
5. Patients with good periodontal and general health.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are unable to perform routine oral hygiene procedures.
2. Patients with history of smoking.
3. Patients with TMJ disorders.
4. Patients with dental history of bruxism and parafunctional habits or deep bite cases.
5. History of substance abuse.
6. Insufficient vertical inter arch spaces to accommodate the prosthodontic components available, together with a proposed pontic and occasional gingival analogue designs.
7. Patients with uncontrolled diabetes.
8. Absence of opposing occlusion.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Crestal Bone Loss Around Dental Implants Evaluated Through Cone Beam Computed Tomography(CBCT) |
9 Months After Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peri-Implant Soft Tissue Health Around Dental Implants Through Keratinized Mucosa INDEX AND PROBING DEPTH |
3 Months And 9 Months After Implant Placement |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/12/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
A total number of 20 patients with single missing tooth in mandibular and maxillary posterior region will be divided in two groups with 10 in each group randomly Group A- Implant placement with Buttress thread design Group B-Implant placement with V shaped thread design
Study Material The implant system used in this study will be i-Fix®
Following parameters would be recorded a. pre-operative and 9 months CBCT to assess the bone changes around the implant b. pre-operative,immediate post-operative and 9 months RVG after implant placement |