| CTRI Number |
CTRI/2024/05/067147 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the bone height changes around the dental implants with the use of rh-BMP-2 as a coating around implants. |
|
Scientific Title of Study
|
Evaluation of the effect of Recombinant Human Bone Morphogenic Protein-2 on crestal bone height and osseointegration around endosseous implants |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moturi Padmini Raj |
| Designation |
MDS |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000198079 |
| Fax |
|
| Email |
prajmoturi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Lakshmi Kanth |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441081047 |
| Fax |
|
| Email |
drkanth99@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Lakshmi Kanth |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9441081047 |
| Fax |
|
| Email |
drkanth99@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509,India. |
|
|
Primary Sponsor
|
| Name |
Moturi Padmini Raj |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences,Takkellapadu,522509 |
| 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 |
| Moturi Padmini Raj |
Sibar Institute of Dental Sciences |
Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH |
9000198079
prajmoturi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences |
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 |
Recombinant human bone morphogenic protien 2 |
implants will be placed with
rhBMP-2 gel coating and patients will be followed up at 3 months and 6 months for evaluating parameters. |
| Comparator Agent |
Without Recombinant human bone morphogenic protien 2 |
implants will be placed without rhBMP-2 gel coating and patients will be followed up at 3 months and 6 months for evaluating parameters. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with an age group of 25-50 years of either gender.
2.Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
3.Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
4.Apparently healthy individuals.
5.Individuals with bone density classified as D2 and D3 type of bone.
|
|
| ExclusionCriteria |
| Details |
1.Any forms of tobacco users.
2.Pregnant and lactating women.
3.Subjects taking any medication which effect healing and bone metabolism.
4.Individuals with parafunctional habits.
5.History of radiotherapy to head and neck.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the implant stability around implants coated with rhBMP-2 gel. |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the crestal bone level around implants coated with rhBMP-2 gel. |
Baseline ,3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
02/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
BMPs are growth factors, belonging to the transforming growth factor-β family, which induces new bone formation by stimulating the differentiation of multipotent cells. They are osteoinductive in nature. Though 20 types of BMP were identified, BMP-2, 7, 8 and 9 were proved effective in enhancing osteogenic activity; and BMP 2 and 7 are approved for human use promoting bone cell migration, differentiation, and proliferation to enable bone remodeling around the implant. Patient selection will be done after the assessment of eligibility criteria. In Phase I therapy oral prophylaxis and surgical stunt fabrication will be done. And patient will be recalled after 1 week for surgical procedure.The procedure will be performed under local anesthesia using 2% lignocaine containing adrenaline 1:80,000.A midcrestal incision will be given in both cases. A mucoperiosteal flap will be elevated and osteotomy site will be prepared. In Group 1 patients, implants will be placed without rhBMP-2 gel coating and in Group 2 implants will be coated with rhBMP-2 gel. After placement, stability will be checked with RFA at baseline.Cover screw will be given following the implant
placement and flaps will be approximated and sutured. Patient will be recalled after 3 months and 6 months for evaluation of parameters like RFA and IOPA.
. |