Comparison of 3Mixtatin Pulpotomy and Metapex Pulpectomy in Primary Molars With Irreversible Pulpitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-9
SponsorCairo University
About this trial
The present study aims to evaluate the clinical and radiographic success of pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to 9 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged from 4 to 9 years with vital primary molars showing signs of irreversible pulpitis.
Children with spontaneous pain lasting a few seconds to several hours.
Pain is intensified by thermal stimulus and persists after its removal.
Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
Disqualifiers
Unrestorable primary molars.
Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
Medically compromised patients who have systemic disease.
Uncooperative children who refuse treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Metapex
DrugPulpectomy using Metapex
3Mixtatin
Drugpulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: metapex pulpectomyActive comparator 1 intervention
Group B: 3Mixtatin PulpotomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical success
* Pain to percussion will be assessed by applying a light-tapping force to the relevant tooth using the blunt end of the dental probe. Tapping will be applied as gently as possible from a 1 cm distance, either present or absent. * Swelling will be assessed through clinical examination, either present or absent. * The sinus tract or fistula will be assessed through clinical examination, either present or absent. * The mobility of teeth will be assessed by applying pressure to the ends of two metal instruments, either present or absent. * The principal investigator and the co-supervisor will undertake this clinical assessment on every recall visit during the 3, 6, 9, and 12 months follow-up period.
Time frame
3, 6, 9, and 12 months follow-up periodSecondary outcomes
1
Radiographic Success
* Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs. * The radiographic assessments will be performed as baseline data at the first visit following the procedure completion and at 6 and 12 months after the baseline * The Two blind assessors will independently evaluate the radiographic outcomes.
Time frame
6 and 12 months2
Post operative pain
After the completion of treatment, post-operative pain will be assessed using the Visual analog scale. This scale comprises six faces, with numbers ranging from 0 to 10 and word descriptions. During follow-up visits, the patients are asked to point to the face that best represents their feelings.
Time frame
1 week, 3, 6, 9, and 12 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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