Clinical trial NCT03119779: Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
Official title: The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: pulpotomy
deep caries
permanent molars
MTA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective:

To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.

Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.

Detailed description: Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.

Eligibility criteria: Inclusion Criteria:

* Restorable permanent molars with deep caries and pain could be relieved with analgesics

Exclusion Criteria:

* criteria of exclusion of teeth were:

  * pathological mobility, swelling or tenderness to percussion/palpation;
  * pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
  * at the operative procedure, hemorrhage control is unachievable

Primary outcomes:
measure: Survival rate
timeFrame: 12 months
Secondary outcomes:
measure: periapical radiolucency
timeFrame: 12 months
measure: internal/ external root resorption
timeFrame: 12 months
measure: Root maturation
timeFrame: 12 months
Other outcomes:
measure: Time lapse till final restoration performed
timeFrame: from 5 till 20 minutes
Locations:
Study officials:
affiliation: Assisternt lecturer
name: Passant Nagi, MSc
role: PRINCIPAL_INVESTIGATOR
References: