Postoperative Pain 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
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 4-6years, Medically free and Cooperative.
Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.
Absence of internal or external root resorption.
Absence of periapical or inter-radicular radiolucencies.
Disqualifiers
Uncooperative children.
Children with systemic disease.
Physical or mental disabilities.
Refusal of participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Fanta AF F one rotary files 20 taper 4
DeviceFanta AF F one rotary files 20 taper 4 single rotary file system
Manual files (k files ,Mani, Inc., Japan).
Devicemanual files (k files, Mani, Inc., Japan) size 15,20,25,30
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group I pulpectomy using single rotary file systemExperimental treatment 1 intervention
Group B: Group II pulpectomy using manual files systemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative pain
: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- Severe: Intense pain; unable to concentrate, requires immediate action or medication
Time frame
At 6, 12, 24, 48 and 72 hours and 1 week after TreatmentSecondary outcomes
1
child's behavior level
child's behavior level: will be recorded by using 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)2
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, 12 months)3
Instrumentation time
will be recorded using a stopwatch
Time frame
(During procedure start from anathesia till end of procedure)4
The obturation quality
will be assessed using a radiograph(Using Coll and Sadrian criteria)
Time frame
(Immediately after treatment)Sponsors 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: