| CTRI Number |
CTRI/2024/08/072596 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of powdered tooth combined with amniotic membrane in healing of third molar socket in patients undergoing extraction of tooth |
|
Scientific Title of Study
|
Effectiveness of autogenous dentin graft along with amniotic membrane in post extraction wound healing |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhisha L K |
| Designation |
Undergraduate Student |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Oral Surgery, Room NO 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore
Dakshina Kannada KARNATAKA 575004 India |
| Phone |
7619656032 |
| Fax |
|
| Email |
lknidhisha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Karthik Kumar |
| Designation |
Assistant Professor |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Oral Surgery, Room No 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore
Dakshina Kannada KARNATAKA 575004 India |
| Phone |
9901518944 |
| Fax |
|
| Email |
karthikkumar.kk69@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Karthik Kumar |
| Designation |
Assistant Professor |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Oral Surgery, Room No 2, Ground Floor, A.J. Institute of Dental Sciences, Kuntikana, Mangalore
Dakshina Kannada KARNATAKA 575004 India |
| Phone |
9901518944 |
| Fax |
|
| Email |
karthikkumar.kk69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences,4th T Block, Jayanagar, Bangalore 560041 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Nidhisha L K |
| Address |
A.J. Institute of Dental Sciences, NH 66, Kuntikan, Mangaluru, Karnataka 575004 India |
| Type of Sponsor |
Other [] |
|
|
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 Karthik Kumar |
A J Institute of Dental Sciences |
Department of Oral and Maxillofacial surgery, Room No 2, ground floor ,NH66, Kuntikan, Mangalore Karnataka 575008 Dakshina Kannada KARNATAKA |
9901518944
karthikkumar.kk69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z481||Encounter for planned postprocedural wound closure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autogenous dentin graft along with amniotic membrane |
Autogenous dentin graft along with amniotic membrane with standard of care will be used to facilitate wound healing which will placed once immediately after extraction. Patient will be assessed for wound healing at 10 days, 1 month and 3 months. |
| Comparator Agent |
Standard of Care |
Standard of Care will be provided immediately after extraction. Wound Healing will be assessed at 10 days, 1 month and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Indications for extractions of impacted lower third molar
Patients belonging to ASA I and II
Identical third molar impactions on either sides |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Patients with periodontal diseases
Patients with carious impacted tooth
Periapical pathologies associated with impacted lower molar |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing will be considered to be a success if more than 2/3rd of the socket is filled with bone, which will be assessed using radiograph at Ten days, one month and three months |
Ten days, one month and three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2024 |
| 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="3" 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
|
According to world health organization an
impacted tooth, is the one that is unable to
fully erupt in its normal functional
occlusion/location by its expected age of
eruption, because it is blocked by overlying
soft tissue or bone or another tooth. Impacted
third molars are classified by winters in 1926
according to the long axis of the second molar
as mesioangular impaction, distoangular
impaction, horizontal impaction, vertical
impaction, transverse impaction and inverted
impaction.
In Impacted lower third molar extraction . Surgery, whether prophylactic or therapeutic,
is a very common procedure in the field of
oral and maxillofacial surgery. In case where
the teeth are deeply impacted and covered by
large quantity of bone. The frequency of
impaction lies between 66% and 77% .
In addition to its high prevalence, third molar
extraction is a surgical procedure
accompanied by complications that include
periodontal problems characterized by bone
loss on the distal aspect of the second molar.
Post extraction socket healing is a
coordinated, sequence of biochemical,
physiological cellular response, aiming to
restore tissue integrity and functional
capacity. Over the years, surgical adjuvant,
bone grafting have been used to improve
periodontal status, regeneration, bone
quality .
Over the years, a lot of efforts have been
made to improve the periodontal status of 2nd
molar after surgical removal of third molar.
Osborne et al showed only minimal reduction. of PD or induction of reattachment of gingival
tissues achieved by root planning the distal
aspect of second molar after extraction of an
adjacent impacted third molar. Similarly, little
or no benefit was found with different flap
designs used in these situations. Guided tissue
regeneration (GTR)-based procedures with or
without bone grafting therapies provide some
adjunctive clinical benefit compared to
standard non-grafting procedures.
Augmentation of the osseous defect with
bone grafts has become one of the most
common surgical techniques in recent years.
Various bone-grafting materials have been
used in post extraction site, include
autogenous bone (harvested from the
mandible during the rotatory osteotomy),
allogenic bone, platelet rich plasma, plateletrich fibrin, synthetic bone graft substitutes
(eg, Bio-oss, bioactive glass, and synthetic
calcium hydroxyapatite) and a combination of
these materials. Although different degrees of
success were achieved, the autogenous bone. still proved to be the gold standard for bone
regeneration, because of its osteoconductive
and osteoinductive properties. The autotooth bone graft material is a system that
treats patients by manufacturing bone graft
material from their own extracted teeth. It has
first been introduced by the Korea Tooth Bank
R&D Center and has satisfied many clinicians
and patients for its osteoconduction as well as
osteoinduction capacity.
Human dentin is composed of 70% organic
content with four types of calcium phosphate
(hydroxyapatite, tricalcium phosphate,
octacalcium phosphate, and amorphous
calcium phosphate), which provide dentin
with its osteoconductive properties.
However few studies are done where
autogenous bone graft showed better results
than other bone grafts, but relatively less
studies have addressed combination of
autogenous dentin graft with amniotic
membrane in the extracted socket. Therefore,
the purpose of the study is to evaluate effectiveness of autogenous dentin graft
combined with amniotic membrane in wound
healing after impacted third molar extraction. |