| CTRI Number |
CTRI/2024/02/063221 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessing Periapical Healing: A Comparative Study using three different endodontic sealer using radiograph |
|
Scientific Title of Study
|
Comparative Evaluation of Periapical Healing in
response to Calcium hydroxide, Polydimethyl
siloxane and Calcium Silicate based endodontic
sealers using radiograph. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utkarsh Umre |
| Designation |
PG Student |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH(DU) |
| Address |
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7385588814 |
| Fax |
|
| Email |
utkarshumre24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Sedani |
| Designation |
Associate Professor |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL |
| Address |
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9561468222 |
| Fax |
|
| Email |
doc.shwets@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Sedani |
| Designation |
Associate Professor |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL |
| Address |
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
103,Department of Endodontics Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research (DU) Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9561468222 |
| Fax |
|
| Email |
doc.shwets@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital DMIHER |
|
|
Primary Sponsor
|
| Name |
Institutional funding Sharad Pawar Dental College and Hospital DMIHER |
| Address |
Sharad Pawar Dental College and Hospital DMIHER Sawangi Meghe Warrdha 442001 |
| 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 |
| Utkarsh Umre |
Sharad Pawar Dental College and Hospital DMIHER |
103 DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS Sharad Pawar Dental College and Hospital DMIHER
Wardha
MAHARASHTRA |
7385588814
utkarshumre24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical science Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium Hydroxide based |
With calcium hydroxide, Dia-ProSeal possesses excellent antimicrobial activity. Fast and easy preparation with no wasted material: 1:1 ratio. Low solubility: resistant to material breakdown over time with long-term dimensional stability. Highly biocompatible(for one year). |
| Intervention |
Calcium Silicate based |
Test result shows that even if CeraSeal has high pH(12.73), it has the excellent biocompatibility. So its harmless to human body, also it has excellent biocompatibility understandably. CeraSeal never shrinks in the root canal(for one year). |
| Comparator Agent |
Polydimethyl siloxane based |
NanoSeal-S is a polydimethylsiloxane based self curing, antibacterial root canal sealer fortified with nano silver. It is used in conjunction with gutta-percha for effective sealing root canals of permanent teeth. It exhibits an excellent sealing ability and superior radio-opacity(for one year)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring endodontic treatment
Periapical radiolucency of teeth ranging from (0.5mm – 8 mm)
|
|
| ExclusionCriteria |
| Details |
• Medically / systemically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
• Teeth with Inability to reach the full working length
• Open apex cases
• Pregnant or lactating women
• Root fracture cases
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - It is expected that among the material used in the study Calcium silicate base sealer may give better results |
- It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Poly dimethyl siloxane baased sealer may give better results as compared to Calcium hydroxide used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability. |
1 day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Abstract Background: Success of root canal treatment depends upon 3-D seal obtained after obturation without any presence of post-operative symptoms. The focus of this investigation is on ability of a sealer to form 3D seal and to reduce periapical lesion. The study aims to evaluate periapical healing of teeth treated with calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph. The objectives of this study will be to evaluate periapical healing ability of root canal treated teeth with Diaproseal, Nanoseal-S and Bio-ceramic sealers over the time period of 3, 6 and 9 months; and to compare the periapical healing ability of a root canal treated tooth. Methods: A total of 60 subjects having periapical radiolucencies will be divided into 3 groups of 20 subjects each; Group I- Calcium hydroxide based, Group II- Polydimethyl siloxane based and Group III- Calcium Silicate based sealers. Root canal procedure will be done. Patients will be recalled after 3, 6, 9 months for the evaluation of periapical healing and PAI score check-up using intraoral periapical radiograph. Expected results: It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability. AIM: To evaluate periapical healing of teeth treated with Calcium hydroxide, Polydimethyl siloxane and Calcium Silicate based endodontic sealers using radiograph. METHOD AND MATERIALS: Materials required: - Dia-proseal, Calcium hydroxide based Root Canal Sealer Compositions: Paste A Epoxy resin, zirconium oxide, calcium hydroxide Paste B Calcium tungstate, zirconium oxide, calcium hydroxide Manufacturer: Diadent, Cheongju, Korea Nanoseal-S Composition: Polydimethyl siloxane, Nano Silver powder, Silicone Oil, Platinum Catalyst, Zirconium Dioxide, Paraffin Liquid. Manufacturer: PrevestDenpro, USA Meta CeraSeal Calcium Silicate-based Bio-ceramic Root Canal Sealer Composition: Zirconium oxide, calcium silicates, calcium phosphate, calcium hydroxide, filler, and thickening agents. Manufacturer: Meta Biomed, Korea
Criteria used for evaluation: - Radiograph Periapical index (PAI) | Score | Quantitative bone alterations in mineral structures | | 0 | Intact periapical bone structures | | 1 | Diameter of periapical radiolucency 0.5–1 mm | | 2 | Diameter of periapical radiolucency 1–2 mm | | 3 | Diameter of periapical radiolucency 2–4 mm | | 4 | Diameter of periapical radiolucency 4–8 mm | | 5 | Diameter of periapical radiolucency >8 mm | | E | Expansion of periapical cortical bone | | D | Destruction of periapical cortical bone | SELECTION CRITERIA🞂 Inclusion criteria · Patients requiring endodontic treatment · Periapical radiolucency of teeth ranging from (0.5mm – 8 mm) 🞂 Exclusion criteria · Medically / systemically compromised patients (with immunosuppressive/systemic diseases, patients on medications) · Teeth with Inability to reach the full working length EXPECTED RESULT: - It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability. Conclusion Comparison amongst the three sealers would provide us with the information about the best material which offers better periapical healing to get the best outcome of the root canal treatment by clinician.
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