| CTRI Number |
CTRI/2021/05/033850 [Registered on: 28/05/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Regenerative Treatment for young traumatized teeth |
|
Scientific Title of Study
|
“REGENERATIVE ENDODONTIC TREATMENT IN NON-VITAL IMMATURE VERSUS MATURE PERMANENT INCISORS – A CLINICAL STUDY†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Taruna |
| Designation |
PG student |
| Affiliation |
SGT University |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University,
Gurgaon
Gurgaon HARYANA 122505 India |
| Phone |
9899917559 |
| Fax |
|
| Email |
tarunayadav313@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shalini Garg |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon
Gurgaon HARYANA 122505 India |
| Phone |
9215668621 |
| Fax |
|
| Email |
shaloosandeep@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Taruna |
| Designation |
PG student |
| Affiliation |
SGT University |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon
Gurgaon HARYANA 122505 India |
| Phone |
9899917559 |
| Fax |
|
| Email |
tarunayadav313@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT Dental College, Hospital and Research Center, SGT University, Budhera, Gurugram. |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Faculty of Dental Sciences, SGT University, Gurugram-122505 |
| Type of Sponsor |
Research institution 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 |
| Taruna |
SGT Hospital and Research centre, SGT University, Budhera, Gurgaon |
Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon Gurgaon HARYANA |
9899917559
tarunayadav313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHREE GURU GOBIND TRICENTENARY, GURUGRAM, HARYANA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tooth pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Immature teeth |
Rvascularization procedure will be done in immature teeth by using Biodentine. |
| Intervention |
Mature teeth |
Revascularization procedure will be done in mature teeth by using Biodentine. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Young non-vital permanent incisors both immature
and mature traumatized teeth.
2. Complete and Incompletely formed root.
|
|
| ExclusionCriteria |
| Details |
1. Children with any major illness or any history
of systemic disease.
2. Teeth undergoing root resorption.
3. Teeth with excessive bone loss and questionable
prognosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The elimination of symptoms and the evidence of bony healing. |
Clinical evaluation to be done at baseline, further at 3,6,9 and 12 months.
Radiographic evaluation to be done at 6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Positive response to pulp sensibility testing. |
Clinical evaluation to be done at baseline, further at 3,6,9 and 12 months.
Radiographic evaluation to be done at 6 and 12 months. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Dentistry, it is always a primary concern to
preserve the dentition. But when the pulp is necrotic or damaged, we try to
restore it by artificial restorative materials. The endodontic procedures have
some major limitations in the tooth such as – Discoloration, Prone to fracture,
devitalization of tooth. Overtime, these filling materials cause severe
destruction to the tooth structure and its longevity is severely compromised. Therefore,
we need to use natural method instead of artificial ones to maintain the vitality
of tooth. So, after the introduction of calcium silicate materials and tissue
regeneration based approaches, we are looking forward to use these biological
resources to preserve the tooth. Pulp regeneration treatment has gained popularity in
the recent years. Firstly, it was performed by Nygaard-Ostby in
1961. As per the American Association of Endodontists (AAE), the major aim of
revascularization procedure is to eliminate the symptoms and encourage the
natural healing of the tooth. The regenerative treatment can be done both in
teeth with mature roots (closed apices) and immature roots (open apices). Usually, when the immature permanent teeth undergo any trauma or infection, it is
conventionally treated by apexification or revascularization. Apexification is
a procedure to induce a calcific barrier at the root apex. There
are many drawbacks of apexification which include: long and multiple treatment
sessions, stunted root development, unfavorable crown-root ratio, thinning of
root canal walls which leads to brittle tooth structure and prone to fracture
after post-endodontic restoration.
On the other hand, revascularization procedure/pulp
dentin regenerative therapy promotes the natural development of continuous root
formation and thickening of root canal walls as well as the apical closure.
Thereby, eliminating the risk of root fracture. Revascularization
treatment yields better results in case of pulpal necrosis due to traumatic
injuries as compare to other etiological factors due to absence of bacteria
associated with caries. There are mainly three key factors for
the success of tissue regeneration, which involves namely, (a) Adult stem cells
– have the capacity to form hard tissue (b) Signaling molecules cause cellular
stimulation, proliferation and differentiation (c) A three dimensional (3-D)
physical scaffold for viable growth and differentiation on the cellular level
in regenerative endodontic procedures.
Young tissue may react differently to
regenerative treatment before and after the root formation in non-vital incisors
with etiologic of trauma. It may be due to the difference in size of apical
foramen, stage of maturogenesis at the time of trauma difference in type of
pulp developing structure and its microanatomy. So, the present study is
planned to know the effect of regenerative endodontic treatment in management
of traumatized, non-vital, immature versus mature permanent incisors. |