| CTRI Number |
CTRI/2019/02/017745 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
19/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial study to compare the effect 0f three different root canal sealers on post operative pain and healing of tooth with periapical lesion. |
|
Scientific Title of Study
|
A Comparative Evaluation Of the effect of
various root canal sealers viz Bioceramic sealer ,Calcium hydroxide based sealer and
Resin based sealer on healing rate and post obturation pain after single visit endodontic
treatment in asymptomatic infected root canal-A randomized 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 |
Amrita Kumari |
| Designation |
Junior resident |
| Affiliation |
Faculty of dental sciences BHU Varanasi, UP |
| Address |
Faculty of dental science IMS BHU varanasi
Lady doctor hostel, near sir sundarlal hospital BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451865595 |
| Fax |
|
| Email |
amritakmr0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr H C Baranwal |
| Designation |
professor |
| Affiliation |
Faculty of dental sciences BHU Varanasi, UP |
| Address |
faculty of dental science BHU trauma center varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415286900 |
| Fax |
|
| Email |
dr.hcbaranwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Kumari |
| Designation |
Junior resident |
| Affiliation |
Faculty of dental sciences BHU Varanasi, UP |
| Address |
faculty of dental science BHU varanasi
Lady doctor hostel, near sir sundarlal hospital BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451865595 |
| Fax |
|
| Email |
amritakmr0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of dental science BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Amrita kumari |
| Address |
Endodontics department, Faculty of dental sciences, BHU |
| 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 |
| Amrita Kumari |
Department of Endodontics |
Faculty of Dental Science BHU
Varanasi
UTTAR PRADESH |
09451865595
amritakmr0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apperentaly normal patient with dental asymptomatic apical periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AH Plus root canal sealer |
AH Plus root canal sealer is a resin-based formula with excellent radiopacity, low shrinkage, low
solubility and outstanding flow characteristics. It features a 1:1, paste-to-paste mixing system
for fast, easy preparation and less waste. AH Plus is biocompatible and silver free. AH Plus
sealer offers a four-hour working time and eight-hour setting time. Its thermoplastic properties
make it easy to remove. |
| Intervention |
Bioceramic based sealer (Bioroot RCS) |
BioRoot RCS is the newest endodontic sealer based on tricalcic silicate materials, benefiting
from both Active Biosilicate Technology and Biodentine. BioRoot RCS is a mineral-based root
canal sealer using a tricalcium silicate setting system. The powder part additionally contains
zirconium oxide as a biocompatible radiopacifyier and a hydrophilic biocompatible polymer for
adhesion enhancing. The liquid part contains mainly water, calcium chloride as a setting
modifyier and a water reducing agent. BioRoot RCS is bioactive by stimulating bone
physiological process and mineralization of the dentinal structure (Camps 2015, Dimitrova-
Nakov 2015). Therefore, it creates a favourable environment for periapical healing and bioactive
properties, including biocompatibility (Reichl 2015), hydroxyapatite formation, mineralization of
dentinal structure, alkaline pH and sealing properties. |
| Intervention |
Sealapex |
Sealapex is the original non-eugenol, calcium hydroxide polymeric root canal sealant. This
formulation produces rapid healing and hard tissue formation.This sealer is available in a base
catalyst system. The base contains zinc oxide, calcium hydroxide, butyl benzene, sulfonamide
and zinc stearate. The catalyst contains resins, isobutyl salicylate, barium sulfate, titanium
dioxide and aerosol. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Single rooted mature permanent anterior tooth.
2. Necrotic, uncomplicated teeth with /without draining sinus tracts .
3. No clinical evidence of pathological mobility, root resorption,internal resorption
4. Patient has no medical problem. |
|
| ExclusionCriteria |
| Details |
1. Painful, necrotic tooth with no sinus tract for drainage.
2. Teeth with severe anatomic anomalies or cases with procedural difficulties. .
3. Patients who have acute apical periodontitis with severe pain on percussion.
ï‚· re-treatment cases.
ï‚· Medically compromised patient. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of post operative pain |
1day, 1week, 1month, 3month, 6month, 12month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Periapical healing by radiograph |
1month, 3month, 6month, 12month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/02/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM of study is to 1. To evaluate healing rate and post obturation pain in single visit root canal treatment using Bioceramic sealer (Bioroot RCS Septodont) as a root canal sealer. 2. To evaluate healing rate and post obturation pain in single visit root canal treatment using Calcium hydroxide based sealer (Sealapex Kerr Sybronendo) as a root canal sealer 3. To evaluate healing rate and post obturation pain in single visit root canal treatment using Resin based sealer (AH plus Dentsply DeTrey) as a root canal sealer. 4. To compare healing rate and post obturation pain in single visit root canal treatment with Bioceramic sealer (Bioroot RCS), Calcium hydroxide based sealer (sealapex) and Resin based sealer (AH plus) as a root canal sealer. Scope: In endodontic practice, the success of root canal therapy mainly depend on achieving a compact fluid tight seal of the apical end of the root canal, so as to prevent the ingress and accumulation of irritants causing biological breakdown of attachment apparatus leading to failure. Root canal sealers along with solid core material play a major role in achieving the fluid tight seal. Several types of root canal sealers are used in endodontic practice with each one having own merits and demerits. Sealers are basically selected based on their sealing ability, adhesive properties, biocompatibility & antimicrobial efficacy. Therefore ,with advent of new techniques and knowledge it becomes imperative that the use of advanced materials be used to increase the success rate of root canal treatment in single visit whenever possible. This study might help us to devise an advanced treatment modality directed at enhancing the success rate of root canal treatment and increasing tooth longevity. Method:1 The case will be allocated into three different groups of 20 in each based on sealer used. Initially access cavity will be made under rubber dam isolation using a high speed air motor with water coolant. After shaping and cleaning of canal using 5.25% sodium hypochlorite, 17% EDTA and 2% chlorhexidine as root canal irrigants, each group will be sonic activated and then the canal will be obturated with gutta-percha cones using sealer: in Group 1 bioroot RCS used as a sealer ,in group 2 sealapex used as a sealer and in group 3 AH plus used as sealer by Cold lateral condensation technique followed by GIC restoration . Teeth will then be reviewed clinically and radiographically at 1months,3 months,6 months and 12 months. An intraoral radiograph will be taken as baseline record. |