| CTRI Number |
CTRI/2021/11/038147 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
13/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Radiation Therapy
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
special burs to increase bone thickness for dental implant placement |
|
Scientific Title of Study
|
THE EFFECT OF OSSEODENSIFICATION TECHNIQUE IN NARROW ALVEOLAR RIDGES- A PROSPECTIVE OBSERVATIONAL CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikar Gade |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
NO 18,2ND CROSS,BASAVESHWARA LAYOUT,BEML 3RD STAGE,RARAJESHWARI NAGAR ,BANGALORE 560098
Rajarajeswari Dental College And Hospital , no 14, Kumbolgodu,Mysore Road, Bangalore,560098
Bangalore
KARNATAKA
560098
India |
| Phone |
8073940324 |
| Fax |
|
| Email |
srikar0207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha NS |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery Rajarajeswari Dental College And Hospital , no 14, Kumbolgodu,Mysore Road, Bangalore,560098
Rajarajeswari Dental College And Hospital , no 14, Kumbolgodu,Mysore Road, Bangalore,560098
Bangalore
KARNATAKA
560098
India |
| Phone |
9880194412 |
| Fax |
|
| Email |
drmamathans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srikar Gade |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
NO 18,2ND CROSS,BASAVESHWARA LAYOUT,BEML 3RD STAGE,RARAJESHWARI NAGAR ,BANGALORE 560098
Rajarajeswari Dental College And Hospital , no 14, Kumbolgodu,Mysore Road, Bangalore,560098
Bangalore
KARNATAKA
560098
India |
| Phone |
8073940324 |
| Fax |
|
| Email |
srikar0207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College & Hospital |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital,No14,Kumbolgodu,Mysore Road,Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mamatha NS |
Rajarajeswari Dental College and Hospital,No14,Kumbolgodu,Mysore Road,Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srikar Gade |
Rajarajeswari Dental College & Hospital |
Department of Oral & Maxillofacial Surgery, Room No 3,RRDCH, No 14, Kumbolgodu, Mysore Road, Bangalore 47
Bangalore
KARNATAKA |
8073940324
srikar0207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Rajarajeswari Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
partially edentulous arch |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Radiographic intervention with CBCT
Application of densifying burs in narrow alveolar ridges |
Pre Operative CBCT measuring alveoloar ridge parameters
Application of densifying burs in narrow alveolar ridges
Post operative CBCT measuring alveolar ridge parameters
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged between 18 to 60 years
2)Systematically healthy Subjects
3)Edentulous space in the Maxillary and Mandibular arch
4)Patient with alveolar ridge width (3-4mm) inferior to the optimally placed diameter of implant.
5)Patient with adequate Alveolar bone height of at least 10mm.
|
|
| ExclusionCriteria |
| Details |
1)Atrophic ridges less than 3mm width with no interposition of cancellous bone between buccal and palatal or lingual plates.
2)Knife edge Ridges
3)Patients with active periodontal disease
4)Co-existing vertical defect of bone
5)Patients with tobacco habits
6)History of radiotherapy to head and neck region or treatment with Bisphosphonates
7)Poor oral hygiene and lack of compliance
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Alveolar ridge expansion
2)Increased Insertion Torque
3)Soft Tissue healing
4)Undamaged bone integrity |
baseline,day of surgery,6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue healing |
2 weeks post operatively |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2021 |
| 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) |
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
|
AIM · To evaluate efficacy of osseodensification technique for implant placement in narrow alveolar ridges. OBJECTIVES OF THE STUDY To compare alveolar ridge width before and after implant placement with osseodensification technique using Cone Beam Computed Tomography. To evaluate the Integrity of alveolar ridge after Osseodensification Technique and Implant Placement Clinically. To record the Insertion Torque Value after placement of an implant. To evaluate Soft tissue healing at 2 weeks using Healing index by Landry, Turnbull and Howley To evaluate the changes in the crestal bone levels after implant placement immediately and after a period of 6 months using Cone Beam Computed Tomography |