| CTRI Number |
CTRI/2024/07/069719 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Two-Year Study on Clinical and CBCT Outcomes of Indirect Sinus Lift Procedure Without Bone Graft Material in Patients Missing Upper Back Teet |
|
Scientific Title of Study
|
Clinical and cbct evaluation of indirect sinus lift procedure without using bone graft material in maxillary posterior edentulous patients- a 2-year prospective study |
| 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 Purushottam Rakhewar |
| Designation |
Professor and hod |
| Affiliation |
SMBT dental college and hospital |
| Address |
G-02 Department of Periodontics SMBT Dental college and hospital
amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Professor and hod |
| Affiliation |
SMBT dental college and hospital |
| Address |
G-02 Department of Periodontics SMBT Dental college and hospital
amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Professor and hod |
| Affiliation |
SMBT dental college and hospital |
| Address |
G-02 Department of Periodontics SMBT Dental college and hospital
amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India
Ahmadnagar MAHARASHTRA 422608 India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental college and Hospital,amrutnagar,sangamner-422608 |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [none] |
|
|
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 Purushottam Rakhewar |
SMBT Dental college and hospital |
G-02 Department of
Periodontics Sangamner Ahmadnagar MAHARASHTRA |
9370017343
drpsrakhewar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Commitee on Ethics, SMBT Dental College,Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
to perform the indirect sinus lift procedure without
bone graft material in
partially edentulous patients requiring implant treatment in the posterior maxilla |
indirect sinus lift procedure will be performed in partially edentulous patients without using bone graft and simultaneously osstem implants will be placed in the posterior maxilla. All patients will have an initial baseline examination of clinical and radiographic parameters and then measurements will be taken immediately
at stage 1 surgery, stage 2 surgery, 6 months and 1 year and 2 year follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1] patients that require implant treatment in the posterior maxilla.
2] Patients requiring indirect sinus lift procedure without bone grafting.
3] residual bone height (RBH) should be ≤8 mm on mesial or distal implant side.
4] Patients with age group 18 years or older, and able to understand and sign a written informed
consent form
5] Both male and female
6] Absence of any local anatomical limitations
7] Patient willing for surgery |
|
| ExclusionCriteria |
| Details |
1] Medical history indicating acute or chronic sinusitis
2] Presence of active periodontal disease, diabetes, or metabolic bone disease
3] Insufficient primary implant stability
4] General contraindications to implant surgery
5] Local and systemic conditions affecting bone
6] Poor oral hygiene and motivation
7] Unable to commit to 2-year follow-up
8] Treated or under treatment with intravenous amino-bisphosphonates
9] Lacking antagonistic occlusal surfaces for the study implants at implant loading. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the long-term outcomes of implants placed in the edentulous posterior maxilla using sinus floor
elevation without grafting. |
at baseline, at stage
2, 6 months, 1 year and 2 year interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to measure and analyze bone levels around these implants after sinus floor elevation without grafting |
at baseline, 1 year and 2 year interval |
|
|
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" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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 aim of this study is to evaluate the clinical and radiographic outcomes of the indirect sinus lift procedure without bone graft material in edentulous patients requiring implant treatment in the posterior maxilla over a 2-year period. All the participants will be explained the need and design of the study. Informed and written consent will be obtained from the patients. Thorough clinical case history will be recorded. A full mouth supragingival and subgingival scaling and root planing procedure will be performed. 2 weeks after phase I therapy, clinical evaluation and radiographic evaluation will be performed to confirm the suitability of the sites for this study. Clinical parameters like pain intensity from implant region, implant stability, modified plaque index (PI), modified sulcus bleeding index (mBI), probing pocket depth and width of masticatory mucosa (Wma) will be measured and radiographic parameters like RBH (residual bone height) at implant placement, peri-implant sinus bone levels, implant protrusion into the sinus and peri-implant crestal bone levels will be evaluated. Intraoral antisepsis will be performed with 0.2% chlorhexidine digluconate rinse and an iodine solution will be used to carry out extra oral antisepsis. After administration of local anaesthesia, horizontal crestal incision following, mucoperiosteal flaps will be reflected. To perform indirect sinus lift using CAS kit, first twist drill with appropriate size stopper will be used to reach 2mm short of the sinus floor. After this, CAS drills will be used sequentially till the implant size is reached using the same stopper. The goal will be to widen the osteotomy till the desired implant size. After performing the osteotomy, we will start going deeper by changing the stopper sequentially in 1mm increments till the drop into the sinus floor is felt. Depth gauge will be used to check if the sinus floor has been reached. The membrane will now be lifted using the hydraulic lift system provided. Saline will be used to aid in the lifting procedure. A suitable size OSSTEM implant body will be placed with the help of a rachet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk surgical suture. The interrupted suture will be placed. At Stage 2 – cover screw will be removed and healing abutment will be placed (4 months after stage 1 surgery). 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. In postoperative care antibiotics like amoxcillin 500mg tid for 5 days and analgesic diclofenac sodium 50mg + paracetamol 500mg tid for 5 days will be prescribed, along with chlorhexidine digluconate rinse twice daily for 2 weeks. Sutures will be removed after 10 days postoperatively. Each patient will be reinstructed for proper oral hygiene measures at each appointment, and re-examined at 6 months, 1 year and 2 year. Soft and hard tissue evaluation will be performed at at stage 1 surgery, stage 2 surgery, 6 months,1 year and 2 year follow up. For hard tissue re-evaluation, CBCT of the same study site will be carried out. |