| CTRI Number |
CTRI/2024/06/069606 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how well amniotic membrane and platelet rich fibrin membranes help bone healing around dental implants after sinus lift surgery. |
|
Scientific Title of Study
|
Comparative evaluation of amniotic membrane and platelet rich fibrin membrane on osseous healing post direct maxillary sinus lift augmented with graft around dental implants A randomised controlled 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 |
Sonali Kaundal |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University, Lucknow, Uttar Pradesh |
| Address |
Resident room, sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University
Lucknow UTTAR PRADESH 226003 India |
| Phone |
6230006455 |
| Fax |
|
| Email |
sonalikaundal1964@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kaushal Kishor Agrawal |
| Designation |
Professor Junior Grade |
| Affiliation |
King George Medical University |
| Address |
sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University
Lucknow UTTAR PRADESH 226003 India |
| Phone |
8299612318 |
| Fax |
|
| Email |
drkaushalp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sonali Kaundal |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University, Lucknow, Uttar Pradesh |
| Address |
Resident room, sixth floor, Department of Prosthodontics and Crown and Bridge, King George Medical University
Lucknow UTTAR PRADESH 226003 India |
| Phone |
6230006455 |
| Fax |
|
| Email |
sonalikaundal1964@gmail.com |
|
|
Source of Monetary or Material Support
|
| New Dental building Sixth floor
King George Medical University
Lucknow Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Seminar room, sixth floor, Department of Prosthodontics, Crown and Bridge, New Dental Building, Lucknow |
| Type of Sponsor |
Government 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 Sonali Kaundal |
King George Medical University |
Department of Prosthodontics, Crown and Bridge,
New dental building, Sixth floor, Postgraduate Clinic Lucknow UTTAR PRADESH |
6230006455
sonalikaundal1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King George Medical University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic membrane |
After local anaesthesia and incision, mucoperiosteal buccal flap will be elevated to expose a portion of lateral bony wall of maxillary sinus and direct sinus lift procedure will be performed. Sinus membrane will be kept elevated and osteotomy for implant will be prepared. Implant will be placed and xenograft is placed followed by direct placement of amniotic membrane covering the window(defect area) over xenograft. Flap is closed and follow up of bone healing is done at one week, one month and at six months. |
| Comparator Agent |
Platelet rich fibrin membrane |
placement of Platelet rich fibrin membrane obtained from patients blood will be placed over xenograft. Rest all the procedure is same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult patients free from any compromising systemic diseases.
2. Patients need implant insertion in maxillary premolar/molar area.
3. Severely resorbed maxillae having less than 5mm in height and more than 7mm in width of residual alveolar bone.
4. Adequate inter occlusal space that could accommodate the implant abutment and the future restoration.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled systemic diseases which retard bone healing.
2. Patients who are under bisphosphonates.
3. Presence of any pathology in site of operation.
4. History of maxillary sinusitis or sinus surgery.
5. Heavy smokers
6. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare osseous healing around dental implants in both the groups |
1 week, 1 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absolute and percentage change in area
Change in Peak Systolic Velocity |
1 week, 1 month, 6 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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 |
|
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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
It is difficult to restore an edentulous posterior maxilla with dental implants due to poor bone equality & limited available bone length, and sinus floor augmentation may be a crucial surgical operation for bone augmentation in this area prior to implant placement. Implant insertion in an atrophic maxilla may be hampered by inadequate alveolar ridge breadth and bone height. The posterior maxilla implant rehabilitation may be more difficult due to ridge resorption, maxillary sinus pneumatization, and low bone quality. A reliable and efficient medical procedure is sinus floor augmentation.There have been a number of procedures proposed for the vertical augmentation of the maxillary sinus, with the conventional lateral osteotomy—introduced by Tatum in 1976—remaining the most popular. It is possible to complete the lateral augmentation surgery in one or two phases. The two-stage method refers to placing dental implants after bone healing, whereas the one-stage procedure refers to placing dental implants concurrently with sinus floor augmentation. In the lateral sinus floor augmentation surgery, there are some variations in the graft materials used for bone augmentation and the timing of implant insertion (simultaneous or delayed). Autogenous bone from the iliac crest or maxillary tuberosity, frozen bone, freeze-dried bone, xenogeneic bone, demineralized freeze-dried bone, and hydroxyapatite have all been studied for use in maxillary sinus grafts to speed up the bone healing process and prevent repneumonization of the maxillary sinus after grafting. Recent research on sinus transplants has revealed that the type of bone-graft material utilised can have a different impact on long-term outcomes. Human amniotic membrane (hAM), one of these biologically/naturally generated tissues, has been used in medicine since Dr. Nicholas Sabella first described a clinical case of burns treated by hAM in 1900.It has been documented to have an anti†inflammatory, antimicrobial, antiâ€tumorigenic nature and analgesic action on local application. The components of hAM, collagen, laminin, fibronectin, and elastin, make them ideal for creating a strong framework for tissue engineering. hAM is biologically active compared to other membranes because it releases growth factors that promote cell migration and promote repair. It can be used with different scaffolds and grafts, such as PRF and hydroxyapatite bone graft, or utilised as an occluding membrane in guided tissue regeneration (GTR). To the best of our knowledge, there have been no studies examining hAM’s impact on the maxillary sinus lift surgery with bovine bone graft in comparison to platelet-rich fibrin. Therefore, the purpose of the current study is to evaluate and compare the impact of hAM and Platelet-rich fibrin membrane on Osseous healing and Angiogenesis when combined with a xenograft around dental implants. Aim of the study is to compare the effect of amniotic membrane versus platelet rich fibrin membrane on osseous healing post direct sinus lift augmented with graft around dental implants. |