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Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

ConditionDeep Caries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-6
SponsorCairo University

About this trial

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 4 to 6 years , in good general health

The parents provided written informed consent.

Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.

Restorable teeth.

Disqualifiers

Physical or mental disability.

Unable to attend follow-up visits.

Previously accessed teeth.

Swelling, tenderness to percussion or palpation, or pathological mobility.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulpotomy

    Procedure/Surgery

    After the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.

  • Partial Pulpectomy

    Procedure/Surgery

    Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol. The tooth with then be restored with stainless steel crown

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: MTA PulpotomyExperimental treatment 1 intervention
Group B: Chlorohexidine PulpectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic assessment

Absence of periapical radiolucency or absence of internal/ external root resorption

Time frame
Month 6 , Month 12

Secondary outcomes

1

Clinical effectiveness

absence of any complication or complementary treatment: Absence of spontaneous pain \& Absence of swelling.

Time frame
Month 3,Month 6,Month 9,Month 12
2

Child cooperation

Modified frankl scale ,Categorical rating (rating 1 is definitly negative \- Rating 5 is definitely positive )

Time frame
Day 0
3

Time elapsed till final restoration performed

Stopwatch , measured in minutes

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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