| CTRI Number |
CTRI/2024/02/062321 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of artificial bone Substitute on firmness of Dental Implants |
|
Scientific Title of Study
|
NIL |
| 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 sattyam Wankhade |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9423421428 |
| Fax |
|
| Email |
drsvw6@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr sattyam Wankhade |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Nagpur |
| Address |
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9423421428 |
| Fax |
|
| Email |
drsvw6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr sattyam Wankhade |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Nagpur |
| Address |
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9423421428 |
| Fax |
|
| Email |
drsvw6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded, Department of Prosthodontics, Government Dental College and Hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Sattyam Wankhade |
| Address |
Department of Prosthodontics, Government Dental College and Hospital, Nagpur |
| 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 Sattyam Wankhade |
Government Dental College and Hospital, Nagpur |
Room No 13, Department of Prosthodontics, Government Dental College and Hospital, Nagpur 440003 Nagpur MAHARASHTRA |
9423421428
drsvw6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VYWS Dental College and Hospital, Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers with missing maxillary molars requiring indirect sinus lift procedure. |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autograft, Xenograft and bone putty materials. |
Lifting of sinus membrane with indirect sinus lift procedure and placing of Autograft, Xenograft and bone putty material mixture to maintain the lift of the membrane. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.Maxillary posterior edentulous area
3.Good oral hygiene
4.Healed edentulous area for atleast 6 month- 6mm height and 5mm width
5.Patients providing due informed consent
|
|
| ExclusionCriteria |
| Details |
•Medically compromised (Diabetetic, Hyperthyrodisim, Epilectic etc)
•Carcinoma
•Pregnant
•Smokers
•Chronic alcoholic
•Poor oral hygiene
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in bone level support and stability of implant |
baseline, six months and nine months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount of bone graft resorption |
Six months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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 4 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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
|
The application of Dental implants for the prosthetic rehabilitation of missing teeth has provided a multitude of treatment options for patients. Loss of teeth in posterior maxillary area can lead to adverse consequences. Maxillary sinus pneumatisation is one of these that precludes placement of implants due to anatomical constraints. In this anatomical situation, it can be very difficult to obtain effective primary stability. Maxillary sinus augmentation has been shown to be a predictable method to increase posterior maxillary bone height, and allow placing dental implants when the residual alveolar ridge is deficient in bone volume. Following post extraction resorption amounting to deficient bone volume in posterior maxilla, many approaches have been described to augment the residual bone ridge by ensuring sinus membrane elevation up to 5mm without tearing it. Boyne and James first described the sinus lift technique based on a modification of the Caldwell-Luc sinus revision, involving a lateral approach to the sinus that allows a remarkable bone augumentation upto >10mm even in atrophic ridges. This STUDY Evaluates the effect of grafting materials on implant stability and bone regeneration in patients with transcrestal approach for sinus augmentation at three different time intervals- An Experimental study |