| CTRI Number |
CTRI/2025/05/087422 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Find Out if a Special Bone-Compacting Drill Can Safely Lift the Sinus membrane and improve Dental Implant Success in the Upper Back Tooth Region |
|
Scientific Title of Study
|
Effectiveness Of Osseodensification in Indirect Sinus Lift With Implant 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 |
Dr Dhanalakshmi P |
| Designation |
Postgraduate resident |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no.03, Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital,
Velachery Main Road, Narayanapuram,
Chennai.
Chennai
TAMIL NADU
600100
India |
| Phone |
8883654999 |
| Fax |
|
| Email |
aishulakshmi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijay Ebenezer |
| Designation |
Professor, Head of the Department |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room No.03, Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital,
Velachery Main Road, Narayanapuram,
Chennai
Chennai
TAMIL NADU
600100
India |
| Phone |
9840136328 |
| Fax |
|
| Email |
drvijayomfs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanalakshmi P |
| Designation |
Postgraduate resident |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room No.03, Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital,
Velachery Main Road, Narayanapuram,
Chennai
Chennai
TAMIL NADU
600100
India |
| Phone |
8883654999 |
| Fax |
|
| Email |
aishulakshmi21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhanalakshmi P |
| Address |
Room No.03, Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital,
Velachery Main Road, Narayanapuram,
Pallikaranai,
Chennai |
| Type of Sponsor |
Private medical college |
|
|
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 Dhanalakshmi P |
Sree Balaji Dental College and Hospital |
Room No.03, Department of Oral and Maxillofacial Surgery, Sree Balaji Dental College and Hospital,
Velachery Main Road, Narayanapuram,
Pallikaranai,
Chennai
Chennai
TAMIL NADU |
888 365 4999
aishulakshmi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE(CLINICAL TRIAL) SREE BALAJI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional crestal approach sinus lift with implant placement |
Osteotomy and sinus membrane elevation were performed using the standard crestal approach drills, followed by Implant Placement in the Edentulous Posterior Maxilla of chronic edentulous patients |
| Intervention |
Effectiveness Of Osseodensification in Indirect Sinus Lift With Implant Placement |
Osteotomy and transcrestal sinus membrane elevation performed using Densah™ burs in Osseodensification mode, followed by Implant Placement in the Edentulous Posterior Maxilla of Chronic Edentulous Patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with a Maxillary vertical height of 4-7 mm in the edentulous area, a minimum width of 4mm, and a sloping sinus floor.
2. Edentulous area with tooth present anterior and posterior to it(Molar tooth region)
3. Patients with a History of extraction at least before 6 months
4.Decayed tooth |
|
| ExclusionCriteria |
| Details |
1. Systemic conditions (like Diabetes and osteoporosis) affecting bone healing.
2. Smokers
3. Chronic sinusitis or sinus with any other
benign pathology
4. Pregnant or lactating women.
5. Poor Oral Hygiene |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Implant stability,
2. Increased Bone Density,
3. Faster Healing time
4. Implant Success Rate.
5. Residual bone height
6. Sinus membrane integrity |
Immediate and 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient Satisfaction
2. Implant Survival Rate
3. Residual bone height
4. Sinus membrane integrity
5. Marginal bone loss |
3rd Week, 6th Week, 16th Week |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="1"
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
|
This prospective observational clinical study, conducted at Sree Balaji Dental College and Hospital, aims to assess the effectiveness of osseodensification using Densah burs in indirect sinus lift procedures with implant placement. The study focuses on patients with 4-7mm of residual maxillary bone height in the posterior region. It seeks to evaluate improvements in primary implant stability, implant success rates, and a reduction in procedural complications such as sinus membrane perforation. Fourteen patients will be selected based on strict inclusion and exclusion criteria. The procedure involves standard surgical protocols, including local anesthesia, crestal Incision, and osseodensification using Densah burs before implant placement. Patient will be monitored postoperatively at the 3rd,6th and 16th weeks. Assessment will include Resonance Frequency Analysis(RFA) for implant stability and imaging (IOPA and CBCT)for sinus membrane integrity. As an observational study, no additional intervention beyond standard care will be introduced. Ethical approval has been obtained from the institutional review board, and informed consent will be secured from all participants. Data will be analyzed using IBM SPSS software to evaluate outcomes related to implant performance, patient satisfaction, and sinus lift success. The study ensures adherence to ethical guidelines and regulatory compliance throughout |