3Mixtatin and MTA Vital Pulpotomy in Primary Molars
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University
About this trial
The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Children 4-8 years old
Vital deeply carious primary molars.
No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
Disqualifiers
• Uncooperative children to avoid time waste and attrition bias.
Unrestorable molars
Sign of radiolucency in periapical or furcation area
Widening of PDL space or loss of lamina dura continuity
Trial design
Design model
Parallel
Treatments tested in this trial
3 mixtatin pulpotomy
Drugpulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
MTA pulpotomy
Drugpulp treatment with applying MTA
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: MTA pulpotomyActive comparator 1 intervention
Group B: 3 Mixtatin pulpotomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical success Clinical success clinical success
absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula
Time frame
1 week , 3 months , 6 months , 9 months and 12 monthsSecondary outcomes
1
Radiographic success radiographic success
Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones, internal or external root resorption )
Time frame
3 months , 6 months , 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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