Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
|ClinicalTrials.gov Identifier: NCT03119779|
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : July 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Caries, Dental||Drug: MTA-Anglus Drug: TheraCal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
Experimental: TheraCal vital pulp therapy
Using rubber dam isolation we 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. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
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.
Other Name: TheraCal vital pulp therapy
Active Comparator: MTA vital pulp therapy
Using rubber dam isolation we 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. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
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.
Other Name: MTA-Anglus vital pulp therapy
- Survival rate [ Time Frame: 12 months ]absence of any complication or complementary treatment (absence of spontaneous pain or swelling)
- periapical radiolucency [ Time Frame: 12 months ]presence or absence of periapical radiolucency radiographically
- internal/ external root resorption [ Time Frame: 12 months ]presence or absence of internal/ external root resorption radiographically
- Root maturation [ Time Frame: 12 months ]Root maturation assessment radiographically
- Time lapse till final restoration performed [ Time Frame: from 5 till 20 minutes ]measured using stop watch to assess which material needs less chair side time to be finished.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119779
|Principal Investigator:||Passant Nagi, MSc||Assisternt lecturer|