| CTRI Number |
CTRI/2024/08/072247 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different indirect sinus lift techniques to achieve sinus lift |
|
Scientific Title of Study
|
Comparative evaluation of extent of sinus lift achieved by crestal approach and Osseodensification: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Pawar |
| Designation |
PG-1 |
| Affiliation |
SMBT IDSR, Dhamangaon, Nashik |
| Address |
Department of periodontology, SMBT IDSR, Dhamangaon, Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9834813326 |
| Fax |
|
| Email |
pooja.pawar0880@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Kurdukar |
| Designation |
Reader |
| Affiliation |
SMBT IDSR, Dhamangaon, Nashik |
| Address |
Department of periodontology, SMBT IDSR, Dhamangaon, Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9881808776 |
| Fax |
|
| Email |
drabhikurdukar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr POOJA PAWAR |
| Designation |
PG student |
| Affiliation |
SMBT IDSR, DHAMANGAON, NASHIK |
| Address |
Department of Periodontology, SMBT IDSR, Dhamangaon, Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9834813326 |
| Fax |
|
| Email |
pooja.pawar0880@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, SMBT IDSR Dhamangaon, Nashik, Maharashtra, PIN - 422403, India |
|
|
Primary Sponsor
|
| Name |
Department of Periodontology SMBT IDSR Dhamangaon Nashik |
| Address |
SMBT IDSR, Dhamangaon Nashik |
| 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 Pawar |
Sau Mathurabai Bhausaheb Thorat IDSR, DHAMANGAON NASHIK |
Department no. 303, Department of Periodontology
Nashik
MAHARASHTRA |
9834813326
pooja.pawar0880@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OD SMBT IDSR, DHAMANGAON, GHOTI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Maxillary sinus lift conditions by placement of implant |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAS kit and Osseodensification |
CAS kit is a indirect sinus elevation technique which includes specific reamers for elevation and osseodensification is the other technique which includes densah burs that densifies the bone while drilling and thus elevates the sinus floor |
| Intervention |
Indirect sinus lift technique |
comparing two different techniques of indirect sinus lift for elevating the sinus floor and placement of implant. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Single or multiple edentulous sites in posterior maxillary region indicated for implant placement.
2. Residual bone height (between alveolar crest and sinus floor) is in the range of 4 -8 mm
3. Systemically healthy individuals
4. Pneumatized maxillary sinus
|
|
| ExclusionCriteria |
| Details |
1. Pregnant patients
2. Active sinus infection and inflammation
3. Recent or unhealed extraction sites
4. Patients with medically compromised health
5. Smokers or patient having any adverse habits.
6. Immediate implant placement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be extent of sinus lift achieved |
Preoperative and baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operators satisfaction & time required for surgery in minutes from baseline to 60 mins |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
02/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - PUBLICATION
- For how long will this data be available start date provided 02-12-2024 and end date provided 30-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
With the rise of implant dentistry, dental implants have become the favored and reliable method for replacing missing teeth. However, optimal osseointegration after implant placement requires sufficient quality and quantity of live bone surrounding the osteotomy, ideally 2mm or more. Sinus pneumatization poses a challenge to successful endosseous implant placement in the posterior maxilla. Elevating the sinus is often necessary to facilitate implant placement, requiring the operating clinician’s familiarity with sinus anatomy to prevent intraoperative complications. Various techniques for sinus augmentation have been developed and proven to yield successful outcomes. Over half of implants inserted in the posterior maxilla necessitate sinus floor elevation (SFE). This necessity arises from continuous ridge resorption following tooth extraction, coupled with progressive sinus pneumatization and the common occurrence of poor bone quality in the maxilla. Sinus membrane perforation is identified as the primary complication during SFE procedures, with the incidence varying based on the technique employed. Perforations may occur during either the fracturing of the sinus floor or the elevation of the mucosa. Here, we will compare two distinct techniques of indirect sinus lift, known interchangeably as sinus lift, sinus augmentation, sinus floor elevation, or augmentation of an atrophic maxillary sinus. The two techniques of indirect sinus lifting we will compare are 1.) Crestal approach 2.) Osseodensification approach The crestal approach to the sinus offers a safe and effective method for sinus elevation. This approach utilizes a reamer, known as the CAS drill, to create a conical-shaped osteotomy and fracture the bony floor. The osseodensification (OD) technique involves a specialized set of burs that operate through a non-excavating drilling process. Rotating counterclockwise, these burs induce low plastic deformation of trabecular bone, leading to bone accumulation apically and laterally. This approach has demonstrated high success rates in crestal sinus floor elevation with minimal risk of membrane perforation, utilizing osseodensification (OD) burs, which rotate in the noncutting counterclockwise (CCW) direction |