Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03741816
Status:
UNKNOWN
Last Update Posted:
2019-01-08
First Post:
2018-11-12
Brief Title:
Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Randomized Blind Clinical Trial Two-armed Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians Vital pulp therapy includes indirect and direct pulp capping partial pulpotomy and full pulpotomy Indirect pulp capping is a procedure in which a material is placed on a thin layer of remaining soft dentin that if removed might expose the pulp The objective is dentin bridge formation and pulp vitality preservation
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions
Detailed Description:
Treatment options for permanent mature molars with deep carious lesions and a preoperative diagnosis of reversible pulpitis are varied among clinicians In the last few years a more biological approach is arising interest in the field of Endodontics through the development of calcium-silicate based cements that are used in vital pulp therapy
A great variety of materials have been employed for indirect pulp capping Although calcium hydroxide has been the gold standard for decades for this procedure nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate MTA are preferred The second generation of these cements among which Biodentine Septodont Saint Maur-des-Fossés France and TheraCal LC Bisco Schaumburg IL USA stand out try to overcome the first generation limitations
On the other hand there is a paradigm shift in caries removal techniques Nowadays the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions
The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics Medical and Dental School of University of Valencia Spain
The study protocol that will be followed is
1 Sample size estimation 212 participants 106 per group
2 Informed written consent will be obtained from all participants
3 A full dental and medical history will be obtained from all patients
4 Clinical thermal and electric pulp tests and palpation and percussion and a radiographic examination periapical radiograph and a small-volume cone beam computed tomography CBCT
5 Anesthesia administration and rubber dam placement
6 Selective caries removal technique with high-speed diamond burs with airwater spray for enamel and Cariosolv gel and hand instruments until soft dentin
7 Allocation to one of the two groups Biodentine control or TheraCal LC experimental for indirect pulp capping procedures
8 Final direct composite restoration using the selective etching technique and an universal adhesive
9 Baseline periapical radiograph
10 Follow-up clinical and radiographic follow-up examinations will be conducted at one month six months and twelve months 2 weeks In the one-year follow-up examination a small-volume CBCT will be taken
A great variety of materials have been employed for indirect pulp capping Although calcium hydroxide has been the gold standard for decades for this procedure nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate MTA are preferred The second generation of these cements among which Biodentine Septodont Saint Maur-des-Fossés France and TheraCal LC Bisco Schaumburg IL USA stand out try to overcome the first generation limitations
On the other hand there is a paradigm shift in caries removal techniques Nowadays the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions
The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics Medical and Dental School of University of Valencia Spain
The study protocol that will be followed is
1 Sample size estimation 212 participants 106 per group
2 Informed written consent will be obtained from all participants
3 A full dental and medical history will be obtained from all patients
4 Clinical thermal and electric pulp tests and palpation and percussion and a radiographic examination periapical radiograph and a small-volume cone beam computed tomography CBCT
5 Anesthesia administration and rubber dam placement
6 Selective caries removal technique with high-speed diamond burs with airwater spray for enamel and Cariosolv gel and hand instruments until soft dentin
7 Allocation to one of the two groups Biodentine control or TheraCal LC experimental for indirect pulp capping procedures
8 Final direct composite restoration using the selective etching technique and an universal adhesive
9 Baseline periapical radiograph
10 Follow-up clinical and radiographic follow-up examinations will be conducted at one month six months and twelve months 2 weeks In the one-year follow-up examination a small-volume CBCT will be taken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None