Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186690
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2017-05-27
Brief Title:
Similar Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine
Sponsor:
Jordan University of Science and Technology
Organization:
Jordan University of Science and Technology
Study Overview
Official Title:
1542013 Grant for Mineral Trioxide Aggregate and Biodentine for Vital Pulp Therapy
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
ACTIVE_NOT_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:
This study aimed to evaluate the clinical performance of White MTA MTA Angelus Londrina Brazil and Biodentine in pulp capping of cariously exposed mature permanent teeth
The investigator performed a prospective longitudinal randomized controlled study utilizing vital permanent mature teeth with deep caries Patients will be divided randomly into Biodentine and MTA groups Teeth will be assessed clinically and radiographically prior to the procedure Caries will be excavated under local anesthesia hemostasis is achieved after pulp exposure using NaOCl and will be capped with Biodentine or MTA Clinical and radiographical follow-up will be performed by a blinded calibrated evaluator after six months and one year and yearly after
The investigator performed a prospective longitudinal randomized controlled study utilizing vital permanent mature teeth with deep caries Patients will be divided randomly into Biodentine and MTA groups Teeth will be assessed clinically and radiographically prior to the procedure Caries will be excavated under local anesthesia hemostasis is achieved after pulp exposure using NaOCl and will be capped with Biodentine or MTA Clinical and radiographical follow-up will be performed by a blinded calibrated evaluator after six months and one year and yearly after
Detailed Description:
Study design and ethical approval This prospective longitudinal parallel-design randomized clinical trial was set up and is reported according to CONSORT statement It assessed the outcome of using Biodentine or MTA as a capping material in human mature permanent teeth Ethical approval for this study was obtained from the Institution Review Board IRB number 15413 All participants provided written informed consent after the purpose and methodology were explained in full
Patient recruitment All patients visiting the Initial Treatment Unit and Post Graduate Dental Clinics were screened for inclusion Dental examinations were performed to determine whether the patients fulfilled the needed criteria
Approximately 50 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis from a similar study The patients will be divided into two groups based on the capping material used Biodentine Septodont St Maur-des-Fossés France group and MTA reparative cement Angelus Londrina Brazil group Teeth will be randomly assigned to either group with a coin toss This included patients with a single offending tooth the following patient will be then assigned to the other group to keep sample sizes equal in both groups Patients with more than one offending tooth will have one tooth treated with Biodentine and the other with MTA using again coin toss to randomly distribute capping material among offending teeth
Clinical examination Pre-operative clinical examinations included a visual inspection of the extent of caries gingival health and adjacent soft tissue A percussion test will be performed and the periodontal status will be assessed Pulpal sensibility will also be assessed by cold test with Endo Ice F Colten-Whaledent Germany Patients reporting sharp pain to cold test that did not linger were diagnosed with reversible pulpitis Patients reporting severe lingering or spontaneous pain were diagnosed with irreversible pulpitis
Periapical and bitewing radiographs will be obtained for each offending tooth to assess the extent and location of caries proximity of caries to the pulp restorability of each tooth periapical status and presence of intra-radicular pathosis Radiographs will be taken using a parallel technique and will be viewed by the naked eye using a viewing box with uniform bright light in a darkened room All data will be collected by one examiner to ensure reliability
Clinical protocol Profound local anesthesia of each tooth will achieved by standard infiltration or inferior dental block injection with lidocaine and epinephrine 1100000 Xylestesin-A 3M ESPE Seefeld Germany Then the tooth will be isolated with a rubber dam The clinical crown disinfected with a cotton pellet soaked in chlorhexidine Caries will be excavated using a round high-speed diamond bur with adequate water cooling followed by a round carbide bur Every attempt will be carried to remove all carious tissue before exposing the pulp A cotton pellet moistened with 5 NaOCl to be placed into the cavity before pulpal exposure The size of the pellet varied according to the size of remaining caries The moistened cotton pellet was left in place for 1-5 minutes to achieve hemostasis Sodium hypochlorite-soaked cotton will be used to control bleeding in this study
Once bleeding stopped capping material will be placed over the exposed pulp Failure to stop bleeding within additional 3 minutes indicated incomplete removal of the inflamed pulp In these cases partial or complete pulpotomy will be performed before capping Failure to control bleeding after a full pulpotomy indicated propagation of the inflammation to the radicular pulp
Biodentine will be prepared according to the manufacturers instructions and used to fill half the cavity Biodentine should set within 12 minutes according to the manufacturer MTA reparative cement will be prepared at a powderliquid ratio of 31 using distilled water according to manufacturers instructions MTA to be applied to exposed pulp tissue and adjacent dentine at a thickness of 15 to 3 mm The final restoration will be a resin composite Z250 3M ESPE USA Patients are asked to contact the operator if they experience any pain The first review appointment to be scheduled a week after capping procedure The patient will be questioned about sensitivity mastication discomfort and sensations of pain
Recall protocol Six-month and yearly after follow-up appointments will be scheduled Patients who are not aware of the type of capping material received will be questioned about pain sensitivity and mastication discomfort Clinical examinations to be performed to detect soft tissue swelling sinus tract the integrity of the coronal restoration and tooth mobility The review visits to be performed blindly by another operator Radiographical examinations will also be performed to evaluate the periapical status the formation of the dentine bridge pulpal calcifications or canal obliteration and evidence of tooth discoloration Tooth vitality will be monitored by cold tests Treatment was considered successful based on the following features absence of severe spontaneous pain no discomfort while eating no soft tissue swelling mobility that is no greater than grade I the absence of periapical rarefaction internal or external resorption root canal obliteration and normal viability following pulpotomy
Statistical analysis The data will be processed using the JMP software SAS Institute Inc North Carolina United States with alpha005 The chi-square test significance level of 005 will be used to determine differences between the success rates of Biodentine and MTA The survival probabilities will be compared using The Wilcoxon and the log-rank tests
Patient recruitment All patients visiting the Initial Treatment Unit and Post Graduate Dental Clinics were screened for inclusion Dental examinations were performed to determine whether the patients fulfilled the needed criteria
Approximately 50 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis from a similar study The patients will be divided into two groups based on the capping material used Biodentine Septodont St Maur-des-Fossés France group and MTA reparative cement Angelus Londrina Brazil group Teeth will be randomly assigned to either group with a coin toss This included patients with a single offending tooth the following patient will be then assigned to the other group to keep sample sizes equal in both groups Patients with more than one offending tooth will have one tooth treated with Biodentine and the other with MTA using again coin toss to randomly distribute capping material among offending teeth
Clinical examination Pre-operative clinical examinations included a visual inspection of the extent of caries gingival health and adjacent soft tissue A percussion test will be performed and the periodontal status will be assessed Pulpal sensibility will also be assessed by cold test with Endo Ice F Colten-Whaledent Germany Patients reporting sharp pain to cold test that did not linger were diagnosed with reversible pulpitis Patients reporting severe lingering or spontaneous pain were diagnosed with irreversible pulpitis
Periapical and bitewing radiographs will be obtained for each offending tooth to assess the extent and location of caries proximity of caries to the pulp restorability of each tooth periapical status and presence of intra-radicular pathosis Radiographs will be taken using a parallel technique and will be viewed by the naked eye using a viewing box with uniform bright light in a darkened room All data will be collected by one examiner to ensure reliability
Clinical protocol Profound local anesthesia of each tooth will achieved by standard infiltration or inferior dental block injection with lidocaine and epinephrine 1100000 Xylestesin-A 3M ESPE Seefeld Germany Then the tooth will be isolated with a rubber dam The clinical crown disinfected with a cotton pellet soaked in chlorhexidine Caries will be excavated using a round high-speed diamond bur with adequate water cooling followed by a round carbide bur Every attempt will be carried to remove all carious tissue before exposing the pulp A cotton pellet moistened with 5 NaOCl to be placed into the cavity before pulpal exposure The size of the pellet varied according to the size of remaining caries The moistened cotton pellet was left in place for 1-5 minutes to achieve hemostasis Sodium hypochlorite-soaked cotton will be used to control bleeding in this study
Once bleeding stopped capping material will be placed over the exposed pulp Failure to stop bleeding within additional 3 minutes indicated incomplete removal of the inflamed pulp In these cases partial or complete pulpotomy will be performed before capping Failure to control bleeding after a full pulpotomy indicated propagation of the inflammation to the radicular pulp
Biodentine will be prepared according to the manufacturers instructions and used to fill half the cavity Biodentine should set within 12 minutes according to the manufacturer MTA reparative cement will be prepared at a powderliquid ratio of 31 using distilled water according to manufacturers instructions MTA to be applied to exposed pulp tissue and adjacent dentine at a thickness of 15 to 3 mm The final restoration will be a resin composite Z250 3M ESPE USA Patients are asked to contact the operator if they experience any pain The first review appointment to be scheduled a week after capping procedure The patient will be questioned about sensitivity mastication discomfort and sensations of pain
Recall protocol Six-month and yearly after follow-up appointments will be scheduled Patients who are not aware of the type of capping material received will be questioned about pain sensitivity and mastication discomfort Clinical examinations to be performed to detect soft tissue swelling sinus tract the integrity of the coronal restoration and tooth mobility The review visits to be performed blindly by another operator Radiographical examinations will also be performed to evaluate the periapical status the formation of the dentine bridge pulpal calcifications or canal obliteration and evidence of tooth discoloration Tooth vitality will be monitored by cold tests Treatment was considered successful based on the following features absence of severe spontaneous pain no discomfort while eating no soft tissue swelling mobility that is no greater than grade I the absence of periapical rarefaction internal or external resorption root canal obliteration and normal viability following pulpotomy
Statistical analysis The data will be processed using the JMP software SAS Institute Inc North Carolina United States with alpha005 The chi-square test significance level of 005 will be used to determine differences between the success rates of Biodentine and MTA The survival probabilities will be compared using The Wilcoxon and the log-rank tests
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