| CTRI Number |
CTRI/2023/07/055065 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study of alternate method to root canal treatment in kids teeth |
|
Scientific Title of Study
|
Evaluation of lesion sterlisation and tissue repair (LSTR) technique for the treatment of non-vital primary molars present with pathological resorption |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Anushi Mehandiratta |
| Designation |
PG Student |
| Affiliation |
SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana |
| Address |
Room no 6, Department of Pediatric and Preventive Dentistry,
Faculty of Dental Sciences,
SGT University, Gurgaon
Gurgaon HARYANA 122505 India |
| Phone |
8091794193 |
| Fax |
|
| Email |
anu.meh101@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Anushi Mehandiratta |
| Designation |
PG Student |
| Affiliation |
SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana |
| Address |
Room no 6, Department of Pediatric and Preventive Dentistry,
Faculty of Dental Sciences,
SGT University, Gurgaon
HARYANA 122505 India |
| Phone |
8091794193 |
| Fax |
|
| Email |
anu.meh101@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR Shalini Garg |
| Designation |
Professor |
| Affiliation |
SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana |
| 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 |
|
|
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 |
| Dr Anushi |
SGT hospital and research center,SGT University, Chandu Bhudera, Gurugram, Haryana |
Room no. 6,
Department of Pediatric
and Preventive
Dentistry, Faculty of
Dental Sciences , SGT
university, Gurugram,
Haryana
Gurgaon
HARYANA Gurgaon HARYANA |
8091794193
anu.meh101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURUG RAM,HARYANA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATHOLOGICAL ROOT RESORPTION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lesion Sterlisation and Tissue Repair in the treatment of non vital primary molars in non resorb root |
40 children among 3-8 years with restorable posterior teeth were selected. clinical examination will be conducted at baseline, 3, 6, 9 and 12 months follow up and radiographic examination will be conducted at 6 and 12 months follow up |
| Intervention |
Lesion Sterlisation and Tissue Repair in the treatment of non vital primary molars in resorb root |
40 children among 3-8 years with restorable posterior teeth were selected. clinical examination will be conducted at baseline, 3, 6, 9 and 12 months follow up and radiographic examination will be conducted at 6 and 12 months follow up |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group – 3-8yrs
2. Restorable teeth.
|
|
| ExclusionCriteria |
| Details |
Patient with any systemic disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of this case control study is to compare the success of lesion sterlisation & tissue repair in resorb & non resorb teeth |
the clinical follow up will be assessed at baseline 3 6 9 and 12 months and radiographic follow up will be done at 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To maintain the primary tooth as a natural space maintainer. |
clinical 3, 6, 9, 12 months
radiographical 6 & 12 months. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
28/07/2023 |
| 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="0" 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
|
Preservation of the primary tooth is the best
method of space maintenance for its successor. However, teeth
with infected root canals are a common clinical problem. Pediatric dentists
routinely counter primary teeth showing signs of irreversible pulpitis and
pulpal necrosis. The treatment in such cases are conventional approach or teeth
extraction. Conventional root canal was introduced in early 1932 to save primary
teeth that otherwise would have been extracted. Conventional endodontic therapy is aimed at
elimination of microorganisms from the infected root canals and prevention of
reinfection. Premixed calcium hydroxide and iodoform paste is a universally accepted
obturating material for pulpectomy in primary teeth. However, root resorption of primary molars has been found to be
accelerated following pulpectomy with conventional iodoform containing filling
materials, leading to their early shedding in comparison with homologous teeth
without endodontic treatment.
The further challenge presented to the pediatric
dentist in such conditions where extraction has to be advised and pulpectomy
can’t be done in cases of pathological like internal or external root
resorption. Premature loss of primary teeth bring about disturbances like
ectopic eruption, altered eruption sequence, crowding, delayed eruption, space
loss, functional and speech impairment. So, these types can be managed
with 86.4% of success rate with LSTR.
Hoshino of Niigata University School of Dentistry
invented the concept of LSTR therapy in 1990, and popularized by Takushige ,
in which a mixture of antibacterial medications was used to sterilise root
canals. These new medication combinations were discovered to be capable of
sterilising carious lesions as well as infected necrotic pulps of deciduous
teeth. It
has been also demonstrated that having LSTR in resorbed teeth, the
periradicular radiolucent lesions like inflammatory root resorptions
disappeared or reduced, thus the lesions repaired.
Keeping in view all these things, this technique
which is less invasive, less time consuming, and come with primary aim of
elimination of all the microorganism i.e, sterilization of root canal spaces
which results in good healing. This proves to the beneficial alternative to the
conventional root canals which has limitations in various fields like extensive
root resorption, inadequate bone, and periodontal support, a child belonging to
pre-cooperative age group, and which is also less time consuming and can be
done in one or two sittings.
As it needs the application
of a different antibiotic combinations known as "Triple Antibiotic Paste"
(TAP) which was developed in major part by Hoshino and colleagues . Eventually, the antibiotic paste and its impact on microorganisms
present in carious dentine and diseased pulp received special attention. The
results indicated that the microorganisms had been completely removed from the
radicular system. TAP is a triple antibiotic that contains ciprofloxacin,
metronidazole, and minocycline. TAP can affect both
gram-negative and gram-positive bacteria, and this combination can be effective
against odontogenic microorganisms .
Numerous studies have found
that minocycline causes tooth discoloration . So, in this vivo study
we are using Double Antibiotic Paste(DAP) as it was found to cause minimum or
no tooth discoloration in comparison to minocycline containing TAP
Thus, in this present case control study
we will compare the success of LSTR technique in non vital primary teeth with
and without incidence of pathological resorption using DAP with propylene
glycol as vehicle. |