| CTRI Number |
CTRI/2017/11/010393 [Registered on: 06/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of bone loss in edentulous ridges with and without implants |
|
Scientific Title of Study
|
Comparative Evaluation of Mandibular Posterior Residual Ridge Resorption in Patients Rehabilitated with Conventional Dentures And two anterior Implant - Supported Mandibular Overdentures -An Invivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Channamsetty Praveena |
| Designation |
Post Graduate Trainee |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
SIBAR Institute of Dental Sciences
Guntur
Andhra Pradesh
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9703503835 |
| Fax |
08632292139 |
| Email |
praveena.channamsetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Associate Professor |
| Affiliation |
SIBAR Institute of Dental Sciences Guntur |
| Address |
SIBAR Institute of Dental Sciences
Guntur
ANDHRA PRADESH
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kattimani |
| Designation |
Associate Professor |
| Affiliation |
SIBAR Institute of Dental Sciences Guntur |
| Address |
SIBAR Institute of Dental Sciences
Guntur
ANDHRA PRADESH
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09912400988 |
| Fax |
08632292139 |
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. L. Krishna Prasad, Principal, First floor, SIBAR institute of dental sciences, Guntur, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Ch Praveena |
| Address |
SIBAR Institute of Dental Sciences , Guntur |
| 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 |
| Ch Praveena |
Sibar Institute of Dental sciences,Guntur |
Department of Prosthodontics and Implantology
Room No-4, 1st floor,
Guntur
ANDHRA PRADESH |
9703503835
08632292139
praveena.channamsetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who requires replacement of all teeth
(completely edentulous patients)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional dentures |
- |
| Comparator Agent |
Implant supported mandibular overdentures |
Decreases posterior mandibular residual ridge resorption |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Edentulous period of 3-6 months .
2) Absence of any systemic diseases.
3) Moderate resorption of the mandible (mandible height in the symphysis region between 12 and 18 mm).
4) Adequate inter-arch space of 16-22 mm.
5) Bone density of type 1, 2 &3. |
|
| ExclusionCriteria |
| Details |
1) A medical & personal history that would complicate the outcome of the study.
2) Patients with type 4 bone density.
3) Heavy smokers.
4) Poorly controlled Diabetes Mellitus.
5) Patients with a history of radiotherapy in the head and neck region.
6) Patients with a history of pre-prosthetic surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone loss |
3, 6 months |
|
|
Secondary Outcome
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/07/2014 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A total of 20 completely edentulous
patients (male & female) of age group 40-65 years will be selected based on
the clinical & radiographic examination. All the patients will be grouped into 2
groups.
Group 1: 10 completely edentulous patients to be rehabilitated
with conventional dentures.
Group 2: 10 completely edentulous patients to be
rehabilitated with two implant-supported overdentures placed in the
interforaminal region.
New complete dentures will be
fabricated for both group A & group B patients .Later, in group B patients
, two single stage endosseous implants will be placed bilaterally in the
interforaminal region of the mandibular arch.
The implants will be loaded with mandibular denture two weeks after the
implant placement. Panoramic radiographs for both group A &
group B patients will be taken and compared to
ascertain the possible bone loss at baseline,3 & 6 months.The method consisted of proportional area measurements of the
posterior mandible. The change in Posterior Area Index (PAI) is calculated for
both the groups. |