| CTRI Number |
CTRI/2023/12/060904 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical outcomes of two different maxillary sinus floor augmentation procedures for Dental implant placement |
|
Scientific Title of Study
|
Clinical outcomes of two different maxillary sinus floor augmentation procedures for Dental implants placement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruthilaya G |
| Designation |
Post Graduate - oral and maxillofacial surgery |
| Affiliation |
MAHER UNIVERSITY |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9444615554 |
| Fax |
|
| Email |
dr.shruthilayaganesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Devadoss |
| Designation |
MDS - Associate proffessor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9840722457 |
| Fax |
|
| Email |
dr_pradeepds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Devadoss |
| Designation |
MDS - Associate proffessor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9840722457 |
| Fax |
|
| Email |
dr_pradeepds@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai 600095 |
|
|
Primary Sponsor
|
| Name |
Shruthilaya G |
| Address |
Meenakshi Ammal Dental College and hospital, Alapakkam main road, Maduravoyal chennai 600095 |
| 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 |
| Shruthilaya G |
Meenakshi Ammal Dental College and Hospital |
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai 600095
Chennai
TAMIL NADU |
9444615554
dr.shruthilayaganesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meenakshi Ammal Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pneumatized Maxillary Sinus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct sinus lift augmentation for dental implant placement |
patients with bone volume less than 4.5mm, Follow up for 3 months. |
| Comparator Agent |
Indirect sinus lift augmentation for dental implant placement |
Patients with bone volume more than 4.5 mm less than 8mm. Follow up of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with pneumatized maxillary sinus sinus
Patient consenting to the study
Patient with unilateral or bilateral edentulous space with pneumatized sinus
Patient with insufficient bone volume for implant placement
Alveolar bone height less than 8mm
Patient with controlled systemic condition
Patient with Good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Patient who are not consenting to the study
Patient with uncontrolled systemic conditions
Patient with history of previous failed sinus lift augmentation treatment
Patient with maxillary sinus pathology
Alveolar bone height more than 8 mm
Patient with poor oral hygiene
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sinus lift augmentation provide better implant stability in posterior maxilla |
patients evaluated in 1st week,1st month, 2nd month, 3rd month interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sinus lift augmentation provide better implant stability in posterior maxilla |
patients evaluated in 1st week,1st month, 2nd month, 3rd month interval |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
05/01/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Title - Clinical outcomes of two different maxillary sinus floor augmentation procedure for dental implant placement Type of study - clinical study Intervention - direct and indirect sinus floor augmentation for dental implant placement Outcome - Sinus lift augmentation provides better implant stability in posterior maxilla and increases bone quantity and quality |