| CTRI Number |
CTRI/2020/09/027694 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Influence of bone quantity in determining Implant success in upper front teeth region |
|
Scientific Title of Study
|
Role of palatal bone in determining the success in Immediate Implant Positioning and Provisionalization in maxillary anterior region- A clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N S MAMATHA |
| Designation |
PROFESSOR |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
14 RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS KUMBALAGODU BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9880194412 |
| Fax |
918028437468 |
| Email |
drmamathans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N S MAMATHA |
| Designation |
PROFESSOR |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
14 RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS KUMBALAGODU BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9880194412 |
| Fax |
918028437468 |
| Email |
drmamathans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N S MAMATHA |
| Designation |
PROFESSOR |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
14 RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL RAMOHALLI CROSS KUMBALAGODU BANGALORE
Bangalore
KARNATAKA
560074
India |
| Phone |
9880194412 |
| Fax |
918028437468 |
| Email |
drmamathans@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |
|
|
Primary Sponsor
|
| Name |
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |
| Address |
Rajiv Gandhi University of Health Sciences Karnataka
4th T Block Jayanagar
Bengaluru 560 041
Karnataka
India
|
| Type of Sponsor |
Other [Autonomous State Health University] |
|
|
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 MAMATHA N S |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
14 RAMOHALLI CROSS MYSORE ROAD KUMBALAGODU
Bangalore
KARNATAKA |
9880194412
918437468
drmamathans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RRDCHET |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z463||Encounter for fitting and adjustment of dental prosthetic device, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immediate implant positioning and provisionalization in maxillary anterior region |
Sample size: 30
Allocation: Non randomized
Masking: Single (Outcome Assessor)
Masking description: The radiographic measurements will be done by the Maxillofacial Radiologist than Maxillofacial Surgeon
Primary Purpose: Immediate implant positioning and provisionalization
Actual study start date: January 2021
Actual primary completion date: December 2022
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with age group of 20-45 years with no significant medical history.
2. Tooth fractured secondary to trauma with intact alveolar bone
3. Grossly decayed tooth with no active infection
4. Endodontic failures with no acute infection and periapical pathology.
5. Presence of residual root/root fracture with intact labial bone.
6. Non restorable tooth
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled periodontal disease, smokers, current alcohol or drug abuse, systemic conditions and medication that would interfere with wound healing or osseointegration, history of radiotherapy in the head and neck region, History of Chemotherapy, long term steroids.
2. Presence of active infections, dentoalveolar fracture.
3. Inadequate width/height of available bone
4. Patients with parafunctional habits.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ISQ 50 TORQUE 20Ncm PALATAL BONE AND LABIAL BONE THICKNESS |
DAY 1 AT 4 AND 12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
AESTHETIC OUTCOME
MORPHOLOGICAL ASSESSMENT OF LABIAL BONE |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is designed with
a aim of evaluating the thickness of the palatal bone and buccolingual
angulation of the maxillary anterior teeth in 3 dimensional positioning of the
immediate implant placement and provisionalization. With these objectives,
Ø
To determine the correlation between the angulation of the
tooth and angulation of the implant in achieving primary stability
Ø
To evaluating the response of the labial cortical plate at 12
months interval.
Ø
To measure the torque value, primary stability and secondary
implant stability.
Ø
To evaluate the horizontal and vertical dimensional changes
in the facial bone following immediate implant placement and provisionalization
in maxillary anterior region.
Ø
To evaluate the aesthetic outcome.
The subject selection will be done according to
the inclusion and exclusion criteria, 30 subjects will be selected, pre-operative
assessment tooth indicated for IIPP and Virtual implant position and prosthesis
is planned and this is executed with guided surgery. Immediate provisional
restoration will be given and after 4 months definitive prosthesis will be
delivered. According to the number of recalls, dates per subject and study
duration will be day 1, after 1 week, 4
months and after 12 months. This proposed study will allow surgeon to
accurately position the implant of ideal size in maxillary anterior region
engaging the palatal bone thereby reducing the surgical time, increases the
bone implant contact, maintains the soft tissue contour and provides the
prosthetic replacement in esthetically demand zone. |