Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars
ConditionIrreversible Pulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University
About this trial
The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children age 4 to 6 years
Medically free children
Cooperative children
Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis
Disqualifiers
Uncooperative children
Children with systemic disease
Children with physical disability
Children with mental disability
Trial design
Design model
Parallel
Treatments tested in this trial
Rotary Instrumentation
Procedure/SurgeryAfter opening the access cavity, the root canal patency will be checked for all the canals located using a size #15 (0.02%) K file, then a single rotary file (AF F One, FANTA, China) (20 taper 4) will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). This file will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.
Manual Instrumentation
Procedure/SurgeryAfter opening the access cavity, manual files (K files, Mani, Inc., Japan) of sizes 15, 20, 25, and 30 will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). These files will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Rotary Instrumentation GroupExperimental treatment 1 intervention
Group B: Manual Instrumentation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intracanal Bacterial Load Reduction
Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.
Time frame
Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.Secondary outcomes
1
Postoperative Pain
Asking the patient and/or Guardian using a 4-point pain scale, the parent of each participant will receive 6 flashcards that include four faces and a word describing each face.
Time frame
at 6, 12, 24, 48, and 72 hours and 1 week after treatment.2
child's behavior level.
will be recorded by using the FRANKEL behavior rating scale: rate 1 means definitely negative "refusal of treatment, fearfulness"; rate 2 means negative "reluctance to accept treatment, uncooperative"; rate 3 means positive "acceptance of treatment, patient follows the dentist's directions"; Rate 4 means definitely positive "good rapport with the dentist, laughter, and enjoyment."
Time frame
Immediately after treatment.3
Instrumentation time
stopwatch
Time frame
during the procedure, starting from anesthesia till end of procedure4
Clinical success
1. absence of swelling will be recorded by visual examination 2. absence of sinus or fistula will be recorded by visual examination 3. pathologic mobility will be recorded by mobility test (pressure using the end of two dental mirrors)
Time frame
At 3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: