| CTRI Number |
CTRI/2024/02/062995 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessing Vertical Ridge Augmentation in the Mandible: A Comparative Study of Autogenous Bone Block Graft and Screw Tent Pole Technique |
|
Scientific Title of Study
|
Comparison of Autogenous Block Bone Graft versus Screw Tent-Pole Technique for Vertical Bone Augmentation in Mandible: A Randomized Controlled 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 Pooja H |
| Designation |
Post Graduate student , Department of Periodontology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
KVG Dental College and Hospital , Department of Periodontology ,room no -11 ,Kurunjibhag , Sullia , Dakshina Kannada
KVG Dental College and Hospital , Department of Periodontology ,room no -11 ,Kurunjibhag , Sullia , Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7019832334 |
| Fax |
|
| Email |
poojahkumar035@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M Dayakar |
| Designation |
HOD and Professor ,Department of Periodontology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
KVG Dental College and Hospital ,Department of Periodontology ,Kurunjibhag ,Sullia ,Dakshina Kannada
KVG Dental College and Hospital ,Department of Periodontology ,Kurunjibhag ,Sullia ,Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9019757027 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja H |
| Designation |
Postgraduate ,Department of Periodontology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
KVG Dental College and Hospital , Department of Periodontology , room no -11 ,Kurunjibhag ,Sullia ,Dakshina Kannada
KVG Dental College and Hospital , Department of Periodontology , room no -11 ,Kurunjibhag ,Sullia ,Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7019832334 |
| Fax |
|
| Email |
pooja2881998@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Pooja H |
| Address |
KVG Dental College and Hospital ,Department of Periodontology ,Room no -11 , SUllia , Dakshina Kannada ,574327 |
| 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 |
| Dr Pooja H |
KVG Dental College and Hospital |
Department of Periodontology , Room no -11 , PG section , Sullia ,Dakshina Kannada ,574327
Dakshina Kannada
KARNATAKA |
7019832334
poojahkumar035@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of KVG DEntal College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, (2) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge, (3) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (4) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ridge Augmentation technique 1 |
Difference in Bone gain level from using autogenous blockgraft vs screw tent pole |
| Comparator Agent |
Ridge augmentation technique 2 |
Screw Tent Pole Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subject with partial edentulism with vertical bone loss in the mandible.
Subjects with residual bone height of 5mm and 7mm and thickness of at least 5mm above the inferior alveolar canal.
Subjects who can understand and accept the study. |
|
| ExclusionCriteria |
| Details |
Subjects having immunological diseases.
subjects having the habit of smoking.
Subjects having osteoporosis, hemophilia, anemia, bisphosphonate or steroid therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of bone gain after augmentation |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| amount of bone fill |
3 month & 6 month |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Congenital abnormalities , chronic edentulism , trauma, periodontal disease and infection are causes of osseous malformation.The remaining alveolar ridge must meet certain minimum requirements before placing an implant hence this study helps in increasing the bone ridge by using and comparing the two techniques used for vertical ridge augmentation .
|