NCT03119779

Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries, Dental

Interventions

Type	Name	Description
DRUG	MTA-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.
DRUG	TheraCal	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-04-30
• Completion: 2017-04-30
• First posted: 2017-04-19
• Last updated: 2017-07-25