Caries, Dental
Conditions
Keywords
pulpotomy, deep caries, permanent molars, MTA
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.
Interventions
DRUGMTA-Anglus
MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.
DRUGTheraCal
TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 12 months | absence of any complication or complementary treatment (absence of spontaneous pain or swelling) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| periapical radiolucency | 12 months | presence or absence of periapical radiolucency radiographically |
| internal/ external root resorption | 12 months | presence or absence of internal/ external root resorption radiographically |
| Root maturation | 12 months | Root maturation assessment radiographically |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time lapse till final restoration performed | from 5 till 20 minutes | measured using stop watch to assess which material needs less chair side time to be finished. |
Outcome results
None listed