| CTRI Number |
CTRI/2024/02/062822 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different apical preparation sizes and taper on outcome of root canal treatment |
|
Scientific Title of Study
|
Effect of different apical preparation sizes and taper on outcome of primary orthograde endodontic treatment assessed using CBCT - a randomized clinical trial |
| 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 Kaadhambari S |
| Designation |
Post Graduate student |
| Affiliation |
R.V..S Dental College and Hospital |
| Address |
Room No -7b
Department of conservative dentistry and endodontics,
R.V.S Dental College and Hospital , Sulur R.V.S.Dental College and Hospital,
Sulur Coimbatore TAMIL NADU 641402 India |
| Phone |
9095958998 |
| Fax |
|
| Email |
kaadha98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sibi Swamy |
| Designation |
Reader (M.D.S) |
| Affiliation |
R.V..S Dental College and Hospital |
| Address |
Room No 7b,Department of Conservative Dentistry and Endodontics,
R.V.S Dental College and Hospital ,Sulur, Coimbatore R.V.S.Dental College and Hospital,
Sulur Coimbatore TAMIL NADU 641402 India |
| Phone |
7811808888 |
| Fax |
|
| Email |
drsibiswamy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kaadhambari S |
| Designation |
Post Graduate student |
| Affiliation |
R.V..S Dental College and Hospital |
| Address |
Room No 7b,Department of Conservative Dentistry and Endodontics,R.V.S Dental College and Hospital , Sulur,Coimbatore R.V.S.Dental College and Hospital,
Sulur Coimbatore TAMIL NADU 641402 India |
| Phone |
9095958998 |
| Fax |
|
| Email |
kaadha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.V.S Dental College and Hospital ,Sulur,Coimbatore 641 402 |
|
|
Primary Sponsor
|
| Name |
Dr Kaadhambari S |
| Address |
R.V.S. Dental College and Hospital |
| 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 Kaadhambari S |
R.V.S Dental College and Hospital |
Room No -7b,
Department of Conservative Dentistry and Endodontics. Coimbatore TAMIL NADU |
9095958998
kaadha98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.V.S INSTITUTIONAL ETHICAL COMMITTEE |
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 |
Effect of apical preparation size of # 30,0.06% taper |
Duration - 6 months |
| Intervention |
Effect of apical preparation size of #25 0.04 taper |
Duration - 6 months |
| Intervention |
Effect of apical preparation size of #25 0.06% taper |
Duration - 6 months |
| Intervention |
Effect of apical preparation size of #30 0.04% taper |
Duration - 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Those who are able to provide informed consent
2.Mature permanent teeth
3.Carious mandibular molars with asymptomatic apical periodontitis
4.Radiographic evidence of periapical lesion in mesial root of mandibular first molars |
|
| ExclusionCriteria |
| Details |
1.Allergies to local anaesthetics or sulphites.
2.Below the age of 18 years.
3.History of significant medical conditions.
4.Teeth with cracks,fractures,endo perio lesion, periapical abscess,furcation involvement.
5.Teeth with more than two canals in mesial root of mandibular molars.
6.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Reduction in size of the periapical lesion after root canal treatment with the different apical preparation sizes and taper |
at baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
24/02/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
After confirming the eligibility
, the patients will be informed about the study design, the clinical procedure
involved, and the associated risks.They will be ensured that root canal
treatment will be performed regardless of whether they decided to participate
in the study or not. Once the patient agreed to participate, verbal and written
consent will be obtained, and the patient will be randomly assigned to 1 of the
4 designated groups. Randomization will be developed to eliminate any bias on
the part of the investigators and to balance the number of patients between the
treatment protocol types.The clinical and CBCT findings will be verified before
the Root Canal Treatment.
Clinical Procedure
After the administration of local anesthesia (Lignocaine HCl with 2% adrenaline 1:80,000 (Lignox 2%
A,Indoco Warren) caries will be excavated, and the access cavity
will be prepared under rubber dam isolation. The working length will
be determined with the help of an electronic apex locator (Coltene Whaledent
Private LTD) and will be confirmed with straight and angled radiographs. Then
canals will be prepared using the step-back technique with 0.02% taper ISO
stainless steel hand files.The apical preparation will be done with No.25,0.04%
; No.25,0.06% ; No.30,0.04% ; No.30,0.06% rotary files ( Hyflex CM) in groups
A,B,C,D respectively and it will be accompanied by irrigation with 5 mL
of 5.25% NaOCl (Prime Dental product
Private Ltd, INDIA) after
each instrumentation cycle. Canal patency will be ensured by passing
a #10 stainless steel file approximately 0.5 to 1.0 mm beyond the working
length. After enlarging, the canals will be irrigated with 5
mL of 17% EDTA for 1 minute. After drying with sterile absorbent points,
the canals will be filled with paste made by mixing calcium
hydroxide powder with 2% chlorhexidine liquid using a
lentulo spiral. The tooth will then temporarily restored with
Intermediate Restorative Material (Prime Dental
product Private Ltd, INDIA). The patient will be recalled
after 1 week. At the next appointment, the paste will be removed with the help
of XP Endo Finisher and copious irrigation with 5.25% NaOCl followed by a final
rinse of 5.0 mL 17% EDTA. If the patient is asympomatic then the canals be
obturated with gutta-percha and bioceramic sealer(CERASEAL,
MetaBiomed,Europe) using lateral condensation technique, if the
patient is symptomatic the canals will be cleaned and shaped and the intracanal
medicament will be placed again and patient will be recalled again after 1 week
. After obturation, the access cavity will be restored. An immediate
postoperative radiograph will be taken using preset exposure parameters and
will be processed manually. Follow-up examinations will be performed after
6 months and it consists of history taking and clinical and CBCT
examination.
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