| CTRI Number |
CTRI/2024/08/072281 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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To study clinical and radiographic difference between two techniques of maxillary sinus lifting and simultaneous implant placement
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Scientific Title of Study
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Comparative Evaluation of Clinical and Radiological Outcomes using
Crestal Approach Sinus Kit and Osseodensification by Densah Burs for
Sinus Membrane Elevation – A Randomized Controlled Trial.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Arvind Nagdeve |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department No. 202 Second Floor Government Dental College And Hospital Medical Square Hanuman Nagar Nagpur 440003 Maharashtra India
Nagpur MAHARASHTRA 440003 India |
| Phone |
917276900857 |
| Fax |
|
| Email |
drojayu.nagdeve@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vivek Thombre |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department No.202 Second Floor Government Dental College And Hospital ,Medical Square Hanuman Nagar Nagpur 440003
Nagpur MAHARASHTRA 440003 India |
| Phone |
9860478817 |
| Fax |
|
| Email |
drvivekthombre@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Vivek Thombre |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Department No.202 Second Floor Government Dental College And Hospital Medical Square Hanuman Nagar Nagpur 440003
Nagpur MAHARASHTRA 440003 India |
| Phone |
9860478817 |
| Fax |
|
| Email |
drvivekthombre@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Dental College And Hospital, Hanuman Nagar, Nagpur 440003 State-Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Ayushi Arvind Nagdeve |
| Address |
Department No 202, Department Of Periodontology Second Floor
Government Dental College And Hospital Nagpur 440003 |
| Type of Sponsor |
Other [Self sponsor ] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Nagdeve |
Government dental college and hospital |
Department no 202 Government Dental College And Hospital Nagpur 440003 Nagpur MAHARASHTRA |
7276900857
drojayu.nagdeve@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crestal Approach Sinus Kit for
Sinus Membrane Elevation |
Patients receiving Implants using Crestal Approach Sinus Kit for
Indirect Sinus lift procedure |
| Comparator Agent |
Osseodensification by Densah Burs for
Sinus Membrane Elevation |
Patients receiving Implants using Osseodensification by Densah Bur
Protocol for Indirect Sinus lift procedure
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients requiring and opting Dental
Implants for replacement of missing teeth in maxillary
posterior region
2. Patient with Sub-antral Height between
5-8mm (SA-2 / SA-3)
3. Adequate Bucco-palatal width in the
edentulous area
4. Patients Having D3 or D4 bone density
5. Patient with age between 25-55 years
|
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| ExclusionCriteria |
| Details |
1. Patients with systemic diseases that contraindicates the
surgery, immune compromised patients
2. Past or present treatment with intravenous aminobisphosphonates.
3. Infection , inflammation , Smokers, undergoing radiation
therapy, sinusitis
4. Pathological growth in the sinus
5. Pregnant or lactating females
6. Poor oral hygiene maintenance
7. Severe bruxism
8. Clenching habit
9. Patients not willing to participate in the study |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Evaluation of Stability of Implants , crestal bone loss, apical bone gain after Implant Placement |
Evaluation of Stability of Implants at baseline, 6 months ,9months,crestal bone loss and apical bone gain after 6 months and 9 months after Implant Placement |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
comparison of Implant Stability ,Crestal Bone Loss & Apical
Bone Gain after Implants placement |
comparison of Implant Stability at baseline, 6 months & 9 months ,Crestal Bone Loss
& Apical
Bone Gain after 6 months & 9 months after Implants placement |
|
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Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Partially, edentulous patients have a problem managing with a conventional prosthesis as they may hinder comfort, aesthetics, and speech.Placing dental implants in the posterior maxillary spaces is a challenging procedure due to maxillary sinus pneumatization which may be physiologic or caused by extraction of teeth Also vertical bone loss after extraction is a major complicating factor which results in decreased vertical bone height.The bone in the posterior maxilla is soft and poorly organized so, to increase stability of dental implant in the posterior maxilla, adequate length should be used., for which maxillary sinus floor elevation is needed in these situations..Primary Stability of dental implant is an important factor in the success rate and healing of bone around dental implant (osseointegration).Surgical sinus floor augmentation can increase the ridge height by approximately 3-5 mm, facilitating simultaneous implant placement . The conventional sinus lift techniques made use of standard drilling protocol with burs for preparing the site for implant placement.Osseodensification is a recent innovation that has the added benefits of preserving bone during osteotomy preparation, increasing the primary stability of the implant, which in turn helps in better osseointegration and success of the implant.The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation and allow for bone preservation and condensation through compaction autografting during osteotomy preparation, thereby increasing the bone density in the peri-implant areas and improving the implant mechanical stability.Despite the fact that there have been numerous studies on sinus membrane elevation ,the application of minimally invasive techniques /approaches has not been thoroughly documented. Not many human studies are available in literature where a comparison has been made between CAS KIT and the new technique of Osseodensification by Densah bur.Thus, this study aims to establish a comparison and highlight the merit (if any) of any one technique. Primary Hypothesis::Is there any difference in the Implant stability, Crestal Bone Loss and Apical Bone Gain around Implants placed by two techniques: viz Crestal Approach Sinus kit and Osseodensification by Densah Bur for Indirect Sinus Lift Null hypothesis:There is no significant difference in the Implant Stability ,Crestal Bone Loss and Apical Bone Gain around Implants Placed using Crestal approach sinus kit and Osseodensification technique by Densah Burs for Indirect Sinus lift procedure .
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