| CTRI Number |
CTRI/2025/03/081642 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the success of a combined endodontic therapy to preserve primary posterior teeth with partial root loss |
|
Scientific Title of Study
|
Strategic management of selectively resorbed roots in primary molars: A prospective cohort study evaluating combined Lesion Sterilization-Tissue Repair and Pulpectomy in 5- to 8-year-old children |
| 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 Mugilan Ravi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry, Ground floor, C Block, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
Raipur
CHHATTISGARH
492099
India |
| Phone |
09538548436 |
| Fax |
|
| Email |
drmugilanravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mugilan Ravi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry, Ground floor, C Block, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
Raipur
CHHATTISGARH
492099
India |
| Phone |
09538548436 |
| Fax |
|
| Email |
drmugilanravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mugilan Ravi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry, Ground floor, C Block, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
a
Raipur
CHHATTISGARH
492099
India |
| Phone |
09538548436 |
| Fax |
|
| Email |
drmugilanravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur(Infractucture) |
|
|
Primary Sponsor
|
| Name |
Mugilan Ravi |
| Address |
AIIMS Raipur, GE Road, Tatibandh, Chhattisgarh, 492099 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Mugilan Ravi |
All India Institute of Medical Sciences, Raipur |
Department of Dentistry, Ground floor, C Block,AIIMS Raipur Campus,GE Road,Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
09538548436
drmugilanravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
K04- Diseases of pulp and periapical tissues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endofusion therapy |
Obturation of the canals in the intact root will be performed using a freshly prepared mixture of Endoflass FS. In the canal(s) of the resorbed root, a freshly prepared mixture of modified triple antibiotic paste using tablets of Ciprofloxacin 500mg, Ornidazole 500mg and Cefaclor 250mg will be used to perform the LSTR procedure |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
i. Spontaneous pain or tenderness to percussion
ii. Deep carious lesion with or without pulp exposure
iii. Presence of chronic apical abscess or sinus tract
iv. Clinically restorable (at least 1 intact wall in the coronal structure) |
|
| ExclusionCriteria |
| Details |
i.
Children with any medical, physical, cognitive or intellectual condition/abnormality
ii.
Clinically non-restorable
iii.
Physiologic or pathologic root resorption of all roots greater than 1/3rd of original length
iv.
Excessive mobility beyond grade 2, as per the classification by Ramfjord(1967).
v.
Internal calcifications or root canal obliteration
vi.
Excessive internal resorption (involving greater than half the radicular width)
vii.
Perforation of the pulpal floor during caries excavation
viii.
Presence of an underlying pathology (cyst/calcified lesion)
ix.
Deviation of the successor tooth germ beyond 30° |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical –Pain, tenderness, swelling,mobility, sinus formation
|
3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic-Size of Radiolucency, reduction in radiolucency, internal resorption |
3,6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pathological root resorption is a sequala of pulp necrosis, which in case of multi-rooted teeth, may lead to selective resorption of a single root, while the other root(s) remains intact. This predisposes to premature tooth extraction, which in children can compromise space management, mastication and speech. A systematic review by Coll et al(2020) suggests performing lesion-sterilisation-tissue-repair(LSTR) therapy when root resorption is greater than one-third and expected duration of survival is less than 12 months, while pulpectomy is recommended for teeth with minimal to no resorption. Pathological root resorption is a sequala of pulp necrosis, which in case of multi-rooted teeth, may lead to selective resorption of a single root, while the other root(s) remains intact. In this study, involving deciduous molars with selective root resorption, pulpectomy and LSTR will be performed in the intact and resorbed root(s), respectively. Irrigation will be done using 2.5% Sodium hypochlorite and normal saline. The intact root(s) will be obturated using Endoflass material, while LSTR will be performed using di-antibiotic paste in the resorbed root. Following the single-visit procedure, all teeth will be restored with a stainless-steel crown and recalled after 3,6 and 12 months for clinical and radiographic evaluation. |