| CTRI Number |
CTRI/2018/05/014019 [Registered on: 21/05/2018] Trial Registered Prospectively |
| Last Modified On: |
11/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical survival of root canal treated teeth restored with reinforced composite restoration. |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical performance of Endodontically treated teeth restored with Short-Fiber reinforced and Zirconia reinforced composite resins as core material – An In vivo Study |
| 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 M Anand |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
2nd floor, Department of Conservative Dentistry and Endodontics,
SRM Dental College,
Bharathi Salai,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
044-22490526 |
| Fax |
|
| Email |
anandsrmbds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Mahalaxmi |
| Designation |
Professor & Head |
| Affiliation |
SRM dental college, Ramapuram |
| Address |
Bharathi Salai, Ramapuram
Chennai, Tamil Nadu , India
Chennai
TAMIL NADU
600089
India |
| Phone |
9381018598 |
| Fax |
|
| Email |
researchmaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Mahalaxmi |
| Designation |
Professor & Head |
| Affiliation |
SRM dental college, Ramapuram |
| Address |
Bharathi Salai, Ramapuram
Chennai, Tamil Nadu , India
Chennai
TAMIL NADU
600089
India |
| Phone |
9381018598 |
| Fax |
|
| Email |
researchmaha@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College,Department of Conservative dentistry and Endodontics,II Floor, Bharathi Salai, Ramapuram
Chennai- 600 089, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
SRM Dental College,Department of Conservative dentistry and Endodontics,II Floor, Bharathi Salai, Ramapuram
Chennai- 600 089, Tamil Nadu, India.
|
| 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 |
| Anand |
SRM Dental College |
2nd floor, Department of Conservative Dentistry and Endodontics,
SRM Dental College,
Bharathi salai,
Ramapuram,
Chennai-89
Chennai
TAMIL NADU |
8344721473
anandsrmbds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Review Board And Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers satisfying ASA criteria I and II between age groups 16 - 45 years |
| Patients |
Patients diagnosed with irreversible pulpitis in mandibular molars, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post endodontic restoration using short fiber reinforced composite |
Root canal treatment followed by post endodontic restoration using Short-Fiber reinforced composite. |
| Comparator Agent |
post endodontic restoration with zirconia reinforced composite |
post endodontic restoration with short fiber reinforced composite in comparison with zirconia reinforced composite |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to actively participate in this in vivo study for periodic follow-ups will be selected.
2. Patients age from 16 to 45 years.
3. Patients with no wall defect (occlusal caries with intact proximal wall) and one wall defect either MO or DO (occlusal caries with involving proximal wall) diagnosed with irreversible pulpitis in mandibular first and second molars.
4. Mature teeth with closed apices.
5. Patients with class I occlusion with intact adjacent and opposing teeth.
6. Patients categorized under ASA (American Society of Anesthesiologists) 1 and 2.
|
|
| ExclusionCriteria |
| Details |
1. Patients categorized under ASA (American Society of Anesthesiologists) 3 and 4.
2. Poor oral hygiene with periodontal diseases and gingival index score more than 1.
3. Patients with non-vital teeth with periapical abscess
4. Patients with fractured teeth, obliterated canals, root resorption and retreatment cases.
5. Buccal and Lingual wall defect and wall thickness less than 2mm.
6. Presence of any para functional habits, wasting disease and maligned teeth.
7. Patients having TMJ problem.
8. Immature teeth with open apex. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To provide proper marginal adaptation, restoration integrity and prevent tooth fracture. |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It increases the longevity of the post endodontic restoration |
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
08/06/2018 |
| 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="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
|
This study is to compare the clinical performance of endodontically treated teeth
restored with short-fiber reinforced composite and zirconia reinforced
composite resin as core material. A 100 patients diagnosed with
irreversible pulpitis will be chosen according to inclusion and exclusion
criteria from the out-patient block, Department of Conservative Dentistry and
Endodontics, SRM Dental College. And the patients divided into 2 groups, group1
fiber reinforced composite and group 2 zirconia reinforced composite, A standardized endodontic procedure
performed using rotary instruments and the canals will be obturated using
standardized GP points and AH Plus resin sealer. Following obturation, the pulp chamber will be cleared of sealer, gutta
percha up to 1 mm apical into the root canal orifice, following which post
endodontic restoration will be done based on the group. The post-endodontic restorations will be clinically evaluated immediately
and in recall visit by two calibrated examiners, blinded to the materials used
and any disagreements during evaluation will be resolved by consensus among the
examiners. Modified US Public Health Service (USPHS) criteria will be used
by calibrators for recall evaluation for a period of 1,
3, 6, 12 and 24months. Evaluation of the functional restorations will
be done in terms of marginal discoloration and adaptation, restoration
integrity, secondary caries and tooth/restoration fracture. The obtained data
will be tabulated and statistically analyzed. |