| CTRI Number |
CTRI/2022/01/039464 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative clinical and X-ray evaluation of mixtures of Zinc oxide – tulsi extract, Zinc oxide - ozonated oil and Zinc oxide eugenol as root canal filling materials in milk teeth |
|
Scientific Title of Study
|
Comparative clinical and radiographic evaluation of mixtures of Zinc oxide – tulsi extract, Zinc oxide - ozonated oil and Zinc oxide eugenol as obturating materials in primary molars: An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishnaben Vachhani |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Room No:09, Department of Pediatric Dentistry, Pacific Dental College and Hospital,
Airport road,
Debari - Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
7490983838 |
| Fax |
|
| Email |
krishna.vachhani969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of the Department |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,
Pacific Dental College and Hospital,
Airport road,
Debari - Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
941458235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of the Department |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,
Pacific Dental College and Hospital,
Airport road,
Debari - Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
941458235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.TULSI 51–JOLLY PHARMA
2. Dr.Jignasha - Ozonil, Ozone Forum of India, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Dr Krishnaben Vachhani |
| Address |
Pacific Dental College and Hospital,
Airport road,
Debari - Udaipur |
| Type of Sponsor |
Other [Self] |
|
|
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 krishnaben Vachhani |
Pacific dental college and hospital |
Room No:09, Department of Pediatric Dentistry, Pacific Dental College and Hospital,
Airport road,
Debari - Udaipur
Udaipur
RAJASTHAN |
7490983838
krishna.vachhani969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers visiting Department OPD |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
zinc oxide eugenol |
mix both the powder and liquid in the ratio 4:1 and obturate the root canals of primary molars using this mixture, clinical and radiographic follow-up for the same will be done at 1 month and 6 and 12 months respectively. |
| Comparator Agent |
Zinc oxide tulsi extract, zinc oxide ozonated oil |
For all the groups of material mix both the powder and liquid in the ratio 4:1 and obturate the root canals of primary molars using this mixture, clinical and radiographic follow-up for the same will be done at 1 month and 6 and 12 months respectively. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Co-operative child
Patient with clinical characteristics showing one or more signs and symptoms like (a) spontaneous pain or tender to percussion, (b) deep caries with pulp exposure, (c) uncontrolled hemorrhage after removal of coronal pulp tissue, (d) presence of chronic apical abscess or sinus tract, and (e) the tooth should be restorable.
Radiographic characteristics include (a) coronal‑radiographic evidence of a deep carious lesion or lesion approximating pulp (b) radicular‑ (i) discontinuity of lamina dura and (ii) furcation involvement less than or equal to half of shortest root in vertical dimension.
|
|
| ExclusionCriteria |
| Details |
Non-restorable teeth
Teeth with physiologic root resorption more than one third of its length or if they have the presence of obliteration of the root canal
Excessive internal resorption
Internal calcifications
Perforation into the bifurcation
Dentigerous cysts.
Patients with any systemic illness or with the previous history of allergy to the antibiotics to be used in the study
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| When both clinical and radiographic success criteria are taken into consideration, the overall success rate of ZnO-ozonated oil is 93.3 %, zinc oxide tulsi extract is 87% and that of ZOE is 70 % |
Radiographic outcome will be taken at 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Introduction The
best space maintainer in both primary and mixed dentition is the primary tooth
itself. This
is not only because of the clinical crown, but also due to the presence of the
roots and periodontium that guide the eruption of the succedaneous permanent tooth. Thus, preserving the integrity of primary dentition is important for
the adequate development of permanent dentition. Primary
teeth should be preserved until they are ready to be replaced. Thus, primary
tooth pulpectomy should be done as a routine procedure after proper examination
and diagnosis confirms its necessity. In view of this, endodontic treatment is
considered the last option for keeping a primary tooth that has irreversibly
affected pulp tissue, due to caries or traumatic lesions, in a child.Presently, the most
commonly used primary teeth root canal filling materials is zinc oxide. It has been reported that
zinc oxide eugenol is an irritant to the periapical tissues does
not resorb at the same rate as the roots and has less
antimicrobial activity. It has been found that eugenol is generally cytotoxic at high concentrations
and has an adverse effect on fibroblasts and osteoblast-like cells. Tulsi
has
been examined pharmacologically for antimicrobial, immunomodulatory,
anti-inflammatory, hypoglycemic,
chemoprotective
and analgesic activities. Ozone
has bactericidal
action,
debriding effect, angiogenesis stimulation capacity
and high
oxidising power. So that we can replace zinc oxide eugenol with zinc oxide tulsi extract and zinc oxide ozonated oil. Aim To evaluate and to compare in
vivo, the clinical and radiographic success of mixtures of zinc oxide –
tulsi extract, zinc oxide - ozonated oil and zinc oxide eugenol as obturating
materials in pulpectomy of primary molars. Method Methodology: A total
of 90 infected primary mandibular molar teeth of healthy children (age 4–9
years) will be included in the study. These infected primary molars will be randomly allocated in three groups i.e zinc oxide tulsi extract, zinc oxide ozonated oil and zinc oxide eugenol. these willl be mixed in powder: liquid ratio of 4:1 and the root canals will be obturated using the same. a clinical follow-up will be taken after a period of 1 month and the radiographic follow-up will be taken after a period of 6 and 12 months. Expected conclusion: When both clinical and radiographic success criteria are taken into consideration, the overall success rate of ZnO-ozonated oil is 93.3 %, zinc oxide tulsi extract is 87% and that of Zinc oxide eugenol is 70 % approximately
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