Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05582317
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2022-09-12
Brief Title:
Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars - a Clinical and Experimental Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
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:
Objective This study was conducted to evaluate the efficacy of combination of biodentine with simvastatin as a pulpotomy agent for vital primary molars clinically and radiographically
Study design 60 primary molars in 20 children aged 4-7 years old were randomly allocated to three groups Biodentine Simvastatin and combination of Biodentine and simvastatin Clinical and radiographic examinations were conducted at 1 3 6 9 and 12 months after treatment
Key words Pulpotomy Primary teeth Biodentine Simvastatin
Study design 60 primary molars in 20 children aged 4-7 years old were randomly allocated to three groups Biodentine Simvastatin and combination of Biodentine and simvastatin Clinical and radiographic examinations were conducted at 1 3 6 9 and 12 months after treatment
Key words Pulpotomy Primary teeth Biodentine Simvastatin
Detailed Description:
Each tooth will be locally anesthetized using topical anesthetic gel benzocaine 20 on the mucosa after drying the area with gauze the application of local anesthesia using Mepivacaine Hydrocholride 2 with Levonordefrin 120000 to the tooth following the recommended technique for each tooth to be treated then the tooth will be isolated using rubber dam and high suction 3 The pulpotomy procedures will be performed as follow- All soft caries will be removed by large spoon excavator Cavity outline will be performed using a sterile 330 carbide bur at high speed 30000 rpm contra-angle hand piece will be used under a water coolant
Access to a pulp chamber will be detected with a probe or if the roof of the pulp chamber is sufficiently thin to see the pulpal tissue When the pulpal exposure is confirmed the roof of the pulp chamber will be removed with a sterile large low speed round bur 4 with water spray
The coronal pulp will be amputated using a sterile sharp spoon excavator until the orifices of the stumps can be seen clearly without remnant tags and the access will be refined with a sterile high speed fissure bur El sayed et al 2019
The pulp chamber will be irrigated with normal saline
Pulp hemostasis will be achieved using a wet cotton pellet with sterile saline applied on the radicular pulp stumps under slight pressure for 2 to 3 minutes
If bleeding cant be controlled within 5 minutes the tooth will be excluded from the study and the needed treatment will be done
4 Depending on group allocation the pulp stumps of molars will be dressed as follows
Group I 20 primary molars were treated with Biodentine -
The mixture of Biodentine will be made according to manufacturers directions as follow
i Biodentine is available in the form of a pre-measured capsule and a liquid in a pipette ii Before the Biodentine capsule is opened it is tapped gently on a hard surface to diffuse the powder
iii Five drops of liquid from the single-dose dispenser is poured into the capsule then it is placed in an amalgamator and mixed for 30 sec
iv The mixture is recovered with the aid of the manufacturer supplied spatula
The mixture of Biodentine is introduced into the pulp chamber using amalgam carrier uniformly placed over the floor of pulp chamber and compacted with a condenser
Group II20 primary molars were treated with Simvastatin -
Simvastatin powder 15 mg is mixed with distilled water to get homogenous paste Shaheen et al 2018
The mixture of Simvastatin then iss delivered to into the pulp chamber using a plastic instrument and compacted with a condenser
Group III 20 primary molars isre treated with combination of Biodentine and Simvastatin-
11 of mixture of Biodentine and Simvastatin paste using one measurable instrument they will be together and the mixture will be delivered to into the pulp chamber using a plastic instrument and compacted with a condenser
5 In three groups the access cavity of all treated molars is filled by restorative glass ionomer cement and all molars are finally restored with stainless steel crowns and cemented by glass ionomer cement
6 Post-operative digital radiograph will be taken at the same visit for all treated primary molars 0-baseline 7 The patients is instructed to perform oral hygiene measures teeth brushing twice daily under supervision of their parents
8 Clinical follow up will be done after one three six nine and twelve months
Digital Radiographic follow up will be done after three six nine and twelve months
Radiographic examination It will be done by taking aiagnostic pre-operative digital periapical radiograph using size 0 Phosphostimulable Phosphor plates PSP scanner and x-ray machine at Oral Radiology Department Faculty of Dentistry Suez Canal University to assess the inclusion and exclusion criteria
9 The patient is asked to come to the clinic between follow up visits if heshe has any complain from the treatment and the alternative treatment will be done according to the case
AII7 Methods of Evaluation
The pulpotomized teeth are judged as clinically and radiographically successful if they met the following criteria Elbardissy et al 2019
Clinically
Absence of pain No tender on percussion No swellingsinus No pathological tooth mobility
Radiographically
No loss of lamina dura Normal periodontal ligament space No externalinternal resorption No periapical furcation radiolucency Evaluation will be done by two independent evaluators Treatment is considered as clinically failure when one or more of the following signs pain tender on percussion swellingsinus or pathological tooth mobility were detected and radiographically failure when one or more of the following signs lamina dura widening in periodontal ligament space presence of externalinternal resorption or presence of periapical furcation radiolucency were detected Time for teeth with pulpotomy failure was defined as the time elapsed between treatment and the first visit in which pathologic finding was detected When failure was detected the tooth was traditionally treated with zinc oxide eugenol pulpectomy or extracted and excluded from the study
Access to a pulp chamber will be detected with a probe or if the roof of the pulp chamber is sufficiently thin to see the pulpal tissue When the pulpal exposure is confirmed the roof of the pulp chamber will be removed with a sterile large low speed round bur 4 with water spray
The coronal pulp will be amputated using a sterile sharp spoon excavator until the orifices of the stumps can be seen clearly without remnant tags and the access will be refined with a sterile high speed fissure bur El sayed et al 2019
The pulp chamber will be irrigated with normal saline
Pulp hemostasis will be achieved using a wet cotton pellet with sterile saline applied on the radicular pulp stumps under slight pressure for 2 to 3 minutes
If bleeding cant be controlled within 5 minutes the tooth will be excluded from the study and the needed treatment will be done
4 Depending on group allocation the pulp stumps of molars will be dressed as follows
Group I 20 primary molars were treated with Biodentine -
The mixture of Biodentine will be made according to manufacturers directions as follow
i Biodentine is available in the form of a pre-measured capsule and a liquid in a pipette ii Before the Biodentine capsule is opened it is tapped gently on a hard surface to diffuse the powder
iii Five drops of liquid from the single-dose dispenser is poured into the capsule then it is placed in an amalgamator and mixed for 30 sec
iv The mixture is recovered with the aid of the manufacturer supplied spatula
The mixture of Biodentine is introduced into the pulp chamber using amalgam carrier uniformly placed over the floor of pulp chamber and compacted with a condenser
Group II20 primary molars were treated with Simvastatin -
Simvastatin powder 15 mg is mixed with distilled water to get homogenous paste Shaheen et al 2018
The mixture of Simvastatin then iss delivered to into the pulp chamber using a plastic instrument and compacted with a condenser
Group III 20 primary molars isre treated with combination of Biodentine and Simvastatin-
11 of mixture of Biodentine and Simvastatin paste using one measurable instrument they will be together and the mixture will be delivered to into the pulp chamber using a plastic instrument and compacted with a condenser
5 In three groups the access cavity of all treated molars is filled by restorative glass ionomer cement and all molars are finally restored with stainless steel crowns and cemented by glass ionomer cement
6 Post-operative digital radiograph will be taken at the same visit for all treated primary molars 0-baseline 7 The patients is instructed to perform oral hygiene measures teeth brushing twice daily under supervision of their parents
8 Clinical follow up will be done after one three six nine and twelve months
Digital Radiographic follow up will be done after three six nine and twelve months
Radiographic examination It will be done by taking aiagnostic pre-operative digital periapical radiograph using size 0 Phosphostimulable Phosphor plates PSP scanner and x-ray machine at Oral Radiology Department Faculty of Dentistry Suez Canal University to assess the inclusion and exclusion criteria
9 The patient is asked to come to the clinic between follow up visits if heshe has any complain from the treatment and the alternative treatment will be done according to the case
AII7 Methods of Evaluation
The pulpotomized teeth are judged as clinically and radiographically successful if they met the following criteria Elbardissy et al 2019
Clinically
Absence of pain No tender on percussion No swellingsinus No pathological tooth mobility
Radiographically
No loss of lamina dura Normal periodontal ligament space No externalinternal resorption No periapical furcation radiolucency Evaluation will be done by two independent evaluators Treatment is considered as clinically failure when one or more of the following signs pain tender on percussion swellingsinus or pathological tooth mobility were detected and radiographically failure when one or more of the following signs lamina dura widening in periodontal ligament space presence of externalinternal resorption or presence of periapical furcation radiolucency were detected Time for teeth with pulpotomy failure was defined as the time elapsed between treatment and the first visit in which pathologic finding was detected When failure was detected the tooth was traditionally treated with zinc oxide eugenol pulpectomy or extracted and excluded from the study
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