Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06027931 |
| Other study ID # |
Ahmed Alani 1983 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2022 |
| Est. completion date |
May 12, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Baghdad |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aims of the study:
1. Assess the clinical and radiographical outcomes (success/failure) of root canal
treatments performed after traditional vs conservative access cavities in permanent
posterior teeth after one-year follow-up.
2. Assess the level of disinfection in root canals accessed by traditional vs conservative
access cavities in permanent posterior teeth before obturation.
Null hypothesis:
1. There is no difference in the clinical and radiographical outcomes of root canal
treatments performed after traditional and conservative access cavities preparation in
posterior teeth after one-year of follow-up.
Description:
Objectives:
1- Primary outcomes:
1. A single-blind, 2- arms, parallel 2-groups, randomized controlled clinical trial will be
conducted in two groups of patients to assess the clinical and radiographical outcomes
(success/failure) of root canal treatments after one year follow-up of posterior teeth
accessed by traditional or conservative access cavities using CBCT as a strict
radiographic adjunct in the assessment in addition to the conventional clinical tests
and the 2- dimensional radiographs.
The successful outcome will include:
I. The absence of clinical signs and symptoms (pain, tenderness to percussion, sinus
tract, swelling).
II. No pathosis is evident on the recall CBCT such as root resorption, new furcal, or
periapical rarefaction.
III. Complete radiographic healing or reduction in the radiolucency if periapical
rarefaction was present preoperatively.
The clinical assessment will be performed by a blind clinical observer and the
radiographical outcome will include an assessment of pretreatment and posttreatment CBCT
scans by blinded two observers (a consensus panel).
2. A microbiological study will be performed to assess the level of disinfection in the
root canals accessed by traditional versus the conservative access cavities by measuring
the total bacterial count before and after the instrumentation of the root canals.
2- Secondary outcomes of the trial:
1- Assessment of crown fracture during the one-year follow-up period (if any). 2-
Assessment of fracture file events during treatment phase. 3- Assess the accuracy of
CBCT vs periapical radiographs in detection of periapical lesion in baseline and
follow-up radiographical assessment.
Materials & Method:
Study design:
This single blind, 2-arms, parallel groups, randomized clinical trial study is planned
to be conducted in a private dental center in Baghdad, Iraq. Ethical approval will be
granted from the Ethics committee in the College of Dentistry/University of Baghdad.
CBCT scan and periapical radiograph will be taken for each case preoperatively, and
another CBCT will be acquired after 1-year follow-up. These scans and radiographs will
be assessed by a consensus panel of two academic endodontists in the department of
Esthetic and restorative dentistry.
A customized case sheet was prepared to be filled before starting with the treatment,
after getting patient approval on participation in the study and signature the consent
form. Case sheets and consent forms in Arabic and English languages are in the last
pages in this protocol.
3.2. Sample size calculation: This study was designed to have 80% power with an alpha
margin of error of 5%, the sample size was calculated using G-power to detect an
expected difference of 25% in failed outcomes between the two groups after one year of
follow-up, a total sample size of 84 root canal treatments in two groups (each group =
42) was calculated anticipating 10% loss of follow-up after one year.
Cases selection:
Inclusion criteria: mature maxillary and mandibular (first molars, first, and second
premolars) that have clinical signs and symptoms of irreversible pulpitis or necrotic
pulps that may or may not show apical periodontitis or chronic apical lesions on the
preoperative CBCT scan or periapical radiograph.
Exclusion criteria: pregnancy, immunosuppression, patients received radiotherapy,
unrestorable teeth, teeth with periodontal probing depths greater than 3 mm,
uncontrolled periodontal disease, presence of airways disease or allergy, vertical root
fractures, signs of root resorption, or patient age over 70 years old.
3.4. Randomization and patients Grouping: Block randomization will be performed using
computer software, the tooth will be the unit of randomization. The following factors
will be equalized during the allocation of teeth to the study arms: Gender
(male/female), Age median, tooth type (molar/premolar), periapical lesion
(presence/absence).
Materials and Equipment:
List of materials:
1. Barbed broaches (Dentsply Maillefer, USA). 2. Disposable nitril gloves (Provi,
Malaysia). 3. Disposable syringe 5ml (Malaysia) 4. EDTA solution 17% (Produits Dentaires
SA, Switzerland) 5. Glyde (Dentsply, Sirona). 6. Bioceramic root canal sealer (BioRoot
™Flow, Septodont). 7. K-files #10 (Dentsply Maillefer, Switzerland). 8. K-files #15
(Dentsply Maillefer, Switzerland). 9. NAOCL 5.25 % (Cerkamed, Poland). 10. Protaper Gold
rotary files (Dentsply, Sirona). 11. Transfer sponges (Dentsply Maillefer, Switzerland).
12. Irrigation needles 0.3 x 25(Cerkamed, Poland). 13. Normal saline. 14. Paper point
(Dentsply, Maillefer, Switzerland). 15. Dam sheets (Sanctuary). 16. Gutta percha cones
(Dentsply Maillefer, Switzerland). 17. Burs (Endo Z).
Instruments:
1. Diagnostic instruments (mirror, probe, and Tweezers) (Medesey, Italy).
2. Rubber Dam kit.
3. Endodontic plugger (Medesey, Italy)
4. Endodontic ruler (Dentsply, Sirona).
5. Ultrasonic Endotips.
6. Ethyl chloride and electric pulp tester.
Equipment:
1. X-Smart IQ Cordless Endodontic Motor (Dentsply, Sirona).
2. High-speed handpiece (Bien Air, Optima, Switzerland).
3. Low-speed handpiece (NSK, Japan)
4. Apex locator (NSK, Apex II, Japan).
5. An ultrasonic scaler (Ultramint & Ultramint Pro, Eighteeth).
Endodontic procedure:
1. Tooth Preparation: An individual patient's data, including case history, clinical and
radiological assessment, treatment plan and periodic follow-up of the patients will be
recorded. Preoperative CBCT and periapical radiograph will be taken for each patient
before starting the treatment. The time required for complete endodontic procedure will
be recorded from the start of treatment for each case. Following anesthesia caries
removal will be performed and restorability will be confirmed. In case of missing walls
(Class II) cavity, pre-endodontic build-up will be performed. With rubber dam isolation,
endodontic treatment will be started, after a straight-line access cavity is prepared by
maintaining standard protocol, with confirmation of patency with size 8 and 10 k files.
Working length will be confirmed with an electronic apex locator and radiograph, canals
will be enlarged using Protaper Gold file system to Size F2 at minimum and for MB2 size
F2 will be considered the master apical file with 2% sodium hypochlorite irrigation
throughout the procedure, finally, the irrigant will be left in the canal and activated
by smooth ultrasonic file (size 15, 0.02 taper) that placed into the canal to 1 mm short
of the WL without touching the walls, enabling it to vibrate freely for 1 min (Hegde and
Arora, 2015). Then final irrigation was done with 17% liquid ethylenediamine tetra
acetic acid (17%EDTA) to remove the smear layer then irrigation with 2.5% NaOCl solution
was placed and agitated for 60 seconds followed by a final irrigation with 1 mL of
saline solution (Tavares, 2020). The canals will be dried with paper point, and master
cone (gutta-percha) to be selected depending on master apical file for canals.
Obturation will be performed with bioceramic sealer (BC) using single cone technique.
2 Bacterial Count (Sample Collection): During sample collection, a sterile absorbent
paper points size F2 will be introduced individually in the pulp chamber space before
access cavity preparation and remained in this position for 60 seconds. After this, the
paper point will be stored in a sterile microtube (2 mL) containing 1 mL pyrogenic water
for subsequent microbiological analysis of Colony Forming Unit (CFU). This will be
considered the base line measurement. After access cavity preparation and
instrumentation, the second paper point will be inserted in the root canal space and
remain in this position for 60 seconds and then will be stored in a sterile microtube (2
mL) containing 1 mL pyrogenic water for subsequent microbiological analysis of Colony
Forming Unit (CFU). This will be regarded as a second measurement for comparison
purposes.
3. Obturation BC sealer is chosen to be used in this study as it has exceptional
dimensional stability and does not shrink upon setting; it is non-resorbable inside root
canal. Furthermore, the formation of calcium hydroxide as a by-product of the setting
reaction (initiated by moisture present in dentinal tubules) produces a very high
alkaline pH (12.8) rendering the material antibacterial. It exhibits excellent
biocompatibility; significant stimulation of periodontal regeneration and it is
osteoconductive. All teeth will be referred back for final restoration within 1 month.
Bioceramic root canal sealer is supplied in premix tube with disposable tips of narrow
caliber. The syringe cap is to be removed from the syringe and intra canal tip to be
attached with a clockwise twist to the hub of the syringe. Sealer will be injected into
the coronal half of the canal and premeasured master gutta-percha (GP) point will be
inserted it into the canal very slowly. GP carried sufficient sealer to the apex. Excess
GP points will be removed from the pulp chamber by a heated plugger.
4. Review of patients: Patients will be reviewed with a clinical and radiographic
examination, one year after treatment. During this examination, CBCT will be taken using
the same exposure settings as the initial scan.
5. Radiographic assessment: Two examiners who had not been involved in clinical
examination or treatment of patients will assess all the CBCT scans. Preoperative and
follow-up CBCT images will be assessed for the presence of apical periodontitis, and
dimension of periapical lesion.
The assessment will be carried out on the coronal and sagittal slices at the equatorial
level of the tooth of interest.
