| CTRI Number |
CTRI/2018/04/013497 [Registered on: 26/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Increasing the width of residual jaw bone using a combination of ones own bone and bone substitute with screw placement at the same time |
|
Scientific Title of Study
|
Horizontal Ridge Augmentation with
Simultaneous Implant Placement using a Collagen Membrane with a Combination of Autogenous Bone and Anorganic Bovine Bone Mineral |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tarun Kumar AB |
| Designation |
Professor |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no.10, Bapuji Implant centre, Bapuji Dental College and Hospital, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9886210507 |
| Fax |
|
| Email |
tarundental@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Kumar AB |
| Designation |
Professor |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no.10, Bapuji Implant centre, Bapuji Dental College and Hospital, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9886210507 |
| Fax |
|
| Email |
tarundental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Jaitly |
| Designation |
Post Graduate Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no.5, Department of Periodontics, Bapuji Dental College and Hospital
Davanagere
KARNATAKA
577004
India |
| Phone |
9819838089 |
| Fax |
|
| Email |
drtanyaaj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tarun Kumar AB |
| Address |
Bapuji Implant Centre, Room no.10, Bapuji Dental College and Hospital, Davangere- 577004 |
| Type of Sponsor |
Other [Dr. Tarun Kumar AB] |
|
|
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 Tarun Kumar AB |
Bapuji Dental College and Hospital |
Room no.5, Department of Periodontics, Bapuji Dental College and Hospital. Davangere- 577004
Davanagere
KARNATAKA |
9886210507
tarundental@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Bapuji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with atrophic edentulous maxilla and mandible willing for Implant supported prosthesis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Ridge width will be measure clinically using Caliper and radiographically using CBCT. Implant exposure will be measured using UNC-12 probe |
Gain in ridge with will be evaluated with values at baseline and 6 months post operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects within the age group of 18-45 years
2. Subjects with good general health
3. Subjects with good oral hygiene
4. Horizontal ridge defect with bucco-lingual dimension of > 2mm to ≤ 5 mm at crest
5. Edentulous ridges with one to four teeth missing
6. Horizontal ridge deficiency at the level of alveolar crest
7. Site with small to moderate bone defect
8. Site should allow implant insertion with primary stability and optimal prosthetic positioning |
|
| ExclusionCriteria |
| Details |
1. Subjects with compromised medical history that would complicate the outcome of the study
2. Subjects who are smokers, alcoholics and tobacco chewers
3. Women who are pregnant or lactating mothers
4. Radiation therapy to head or neck region within 5 years
5. Subjects with high or moderate parafunctional activity
6. Subjects on drug therapy which can affect the outcome of the treatment (Bisphosphonates, anti-platelets and anti-coagulants)
7. Subjects with vertical ridge defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The gain in ridge width which is the difference between the post-operative and pre-operative bone width |
The gain in ridge width which is the difference between the post-operative and pre-operative bone width |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implant stability Quotient (ISQ). ISQ uses resonance frequency analysis |
Implant stability will be measured at the time of implant placement and 6 months post-operatively |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
22/12/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and
anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int
J Periodontics Restorative Dent. 2013; 33: 299-307 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Endosseous implants have gained wide acceptance as treatment of choice for replacement of missing teeth. An important requisite for success of implant is osseointegration which requires adequate quality and quantity of bone. An insufficient amount of alveolar ridge in both dimensions, vertical and horizontal is often encountered in dental practice due to the consequences of oral diseases and tooth loss. This has led to the development of several methods for alveolar ridge augmentation. Augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. This study is conducted for a duration of 6 months to evaluate 1. the effectiveness of combination of autogenous particulated bone graft and ABBM and its stabilization using native collagen membrane in augmenting horizontal ridge defects and 2. To evaluate pre and post-operative changes in ridge width and to quantify the gain in ridge width along with osseointegration of implants, 6 months post treatment using clinical and radiographic assessment A total of 12 patients are selected from the out-patient department of Periodontics, Bapuji Dental College and Hospital based on the inclusion criteria. Informed consent was obtained and after complete blood investigation and assessment of pre-operative CBCT scan, patient was scheduled for the procedure. Under local anesthesia, implants of ideal diameter are placed within the prepared osteotomy site, the implant exposure and the horizontal defect is augmented with a mixture of autogenous bone and Anorganic bovine bone mineral. A resorbable membrane is secured over the gtaft using titanium tacks and periosteal vertical mattress suture followed by tension free flap closure of the surgical site. Following clinical parameters are recorded:
• Primary implant stability will be measured using insertion torque value and Implant Stability quotient (ISQ) by resonance frequency analysis • Length of implant exposure is measured in millimeter (mm) using colorvue UNC12 probe at baseline and 6 months post-operatively to check for wound dehiscence • Clinical measurement of ridge width will be carried using a caliper at baseline and six months of augmentation procedure to quantify the difference in ridge width Radiographic analysis is done on the sagittal section of CBCT scan. Appropriate statistical analysis will be done. |