| CTRI Number |
CTRI/2024/05/068115 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [absorbable nano-hydroxyapetite/gelatin/carboxymethylcellulose scaffold] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the bone regrowth with and without the use of 3D scaffold material after lower molar tooth removal |
|
Scientific Title of Study
|
Comparative evaluation of the bone regeneration with and
without use of 3d scaffold matrix in adult patients in defects
following intra-alveolar extraction of mandibular molars – An
Observer Blind Prospective Randomized 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 |
Gaury Agrawal |
| Designation |
1st MDS student |
| Affiliation |
MGM Dental College and Hospital Kamothe |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and 19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9657866583 |
| Fax |
|
| Email |
agrawalgauri92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srivalli Natarajan |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital Kamothe |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and 19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivalli.shrikanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srivalli Natarajan |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital Kamothe |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and 19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivalli.shrikanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai 410209
|
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
|
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 Srivalli Natarajan |
MGM DENTAL COLLEGE AND HOSPITAL |
MGM Dental College &
Hospital Kamothe 4th
Floor, Department of
Oral & Maxillofacial
Surgery, Plot No. 1 & 2,
Sector - 01(Old 18 &
19), Kamothe, Navi
Mumbai, 410209.
Raigarh
MAHARASHTRA |
9769088803
srivalli.shrikanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No use of 3D scaffold matrix |
Immediately after the extraction, for participant
from Group B no nano hydroxyapatite scaffold will be placed in the extraction socket to evaluate the quality and quantity of bone regeneration |
| Intervention |
Use of 3D scaffold matrix |
Immediately after the extraction, for participant
from Group A nano hydroxyapatite scaffold will be placed in the extraction socket and evaluate quality and quantity of bone regeneration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Participants undergoing dental extraction of
Mandibular 1st or 2nd molars.
b) Participants within age group from 18-60 years of
either gender.
c) Participants willing to be followed up for 12 weeks.
d) Participants willing to undergo Dental Implant
placement following extraction of the Mandibular
Molar at 12 weeks post extraction. |
|
| ExclusionCriteria |
| Details |
a) Participants demonstrating periapical infection/
osteomyelitis/ tissue space infection in association with
the Mandibular molar indicated for extraction.
b) Teeth which require trans-alveolar method of extraction
under local anaesthesia
c) Lone standing Mandibular first or second molars indicated
for extraction.
d) Patients suffering from systemic disease like diabetes
mellitus, osteoporosis, auto immune diseases and on
Medications which are proven to affect bony wound
healing.
e) Female patients who are pregnant.
f) Participants indicated for Mandibular third molar
extractions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the defect fill and alveolar crest resorption along with height and width of the residual alveolar ridge at the site of extraction of mandibular molars by means of CBCT following extraction in adult participants with and without the use of 3D scaffold matrix |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Primary objective 2- To evaluate & compare the bony
regenerate in the extraction socket at 12 weeks for Bone
mineral density (BMD), Bone tissue volume/ total tissue
volume (BTV/TV), Trabecular thickness (Tb.Th), &
trabecular separation/spacing (Tb.sp) through High
resolution Micro CT in adult participants with & without
the use of 3D scaffold matrix. |
At 12 weeks |
Primary objective 3- To evaluate & compare the
Histomorphometry of the bony regenerate in the extraction socket at 12 weeks post extraction for presence or absence of Woven bone, Lamellar bone, Nonviable
bone, Residual scaffold material & Connective tissue in adult participants with & without the use of 3D scaffold
matrix. |
At 12 weeks |
To evaluate and compare the socket wound healing at 3 days and
7 days following extraction with and without use of 3D Scaffold
Matrix in adult participants in defects following intra-alveolar
extraction of Mandibular Molars. |
Day 3 and day 7 post extraction |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
10/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Alveolar Bone resorption is an inevitable consequence of tooth extraction. The basic premise of ridge healing mechanisms post extraction have clearly led to overall volumetric reduction in both horizontal (2.46 to 4.56mm) and vertical (0.8 to 1.5 mm) dimensions averaging up to 50% within 12 months, two thirds of which occurs within the first three months (Lang et al). Socket preservation techniques have always aimed to neutralize these early dimensional changes and maintain the ridge volumes within the envelope at the time of extraction. This is particularly relevant in cases where immediate or early implant placement as socket preservers is not feasible. Advances in biomaterials, and research unravelling the molecular mechanisms of alveolar bone resorption have led to the advent of multiple options ranging from autografts, xenografts, allografts and alloplastic bone substitutes. Factors which have been considered when selecting the appropriate choice have been the site and size of defect, healing time, evidence for safety and effectiveness, price of the graft, and availability of the graft material. The market demand for Alloplast is bound to grow rapidly over other modalities because of various advantages like no risk of transmission of infection, unlimited availability and avoidance of donor site morbidity and slower degradation. The alloplast is segmented into allograft & synthetic materials. The allografts segment includes demineralized bone matrix and others, whereas the synthetic segment is further broken down into ceramic, composite, polymers, and Bone Morphogenic Proteins (BMP). A good blend of osteoconductive, osteoinductive, osteopromotive and osteogenic properties have always governed the performance of these materials and outcomes. Alloplasts also may carry the advantage of being 3 D printable to match the defect in size, shape and volume for customization. While many materials and techniques have been studied to prevent post extraction resorption, none of the currently used techniques provides complete efficacy in terms of time required for regeneration, ridge preservation dimensionally and quality of regenerate. The use of growth factors and tissue engineering concepts is still in its nascent stage and, while promising, requires more clinical trials before we arrive at an economically viable, resorbable, biologically effective and an option amenable to 3 D printing as a one stop solution. Thus a novel three dimensional (3D) scaffold has been developed with the unique combination of nano hydroxyapatite/ gelatin/ carboxymethyl cellulose (nano Hydroxyapetite/ gelatin /Carboxy Methyl Cellulose) for bone tissue engineering by using the solvent-casting method combined with vapor-phase crosslinking and freeze-drying. The aim of this study is to evaluate the potential of absorbable nano Hydroxyapetite /gelatin/ Carboxy Methyl Cellulose as a scaffold to enhance bone formation in defects generated following a Mandibular Molar extraction in Human adults. |