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Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biodentine
Simvastatin
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Apparently healthy children free from any known systemic diseases.
  • Parent willing to participate in the study and signed an informed consent.
  • Patient had at least three restorable primary molars with a caries- exposed vital pulp

Exclusion Criteria:

  • history of spontaneous pain or provoked pain.
  • clinical signs and ̸ or symptoms suggesting a non-vital tooth such as (fistula, sinus tract, soft tissue swelling, mobility or tenderness to percussion).
  • non-Restorable tooth
  • pathologic or physiologic mobility

Sites / Locations

  • Faculty of dentistry, Suez canal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Biodentine

Simvastatin

combination of Biodentine and Simvastatin

Arm Description

20 primary molars were treated by Biodentine

20 primary molars were treated by Biodentine

20 primary molars were treated by Biodentine

Outcomes

Primary Outcome Measures

Clinical assessment
Pain, tenderness, Swelling No tender on percussion. No swelling/sinus. No pathological tooth mobility.

Secondary Outcome Measures

Radiographically:
Lamina dura, periodontal ligament space, resorption Normal periodontal ligament space. No external/internal resorption. No periapical /furcation radiolucency.

Full Information

First Posted
September 12, 2022
Last Updated
October 12, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05582317
Brief Title
Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 1:20000 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 (30,000 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 manufacturer's 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 (II):20 primary molars were treated with Simvastatin :- Simvastatin powder 1.5 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:- • 1:1 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 he/she has any complain from the treatment, and the alternative treatment will be done according to the case. A.II.7: 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 swelling/sinus. No pathological tooth mobility. Radiographically: No loss of lamina dura. Normal periodontal ligament space. No external/internal 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 swelling/sinus 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 external/internal 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biodentine
Arm Type
Active Comparator
Arm Description
20 primary molars were treated by Biodentine
Arm Title
Simvastatin
Arm Type
Active Comparator
Arm Description
20 primary molars were treated by Biodentine
Arm Title
combination of Biodentine and Simvastatin
Arm Type
Active Comparator
Arm Description
20 primary molars were treated by Biodentine
Intervention Type
Drug
Intervention Name(s)
Biodentine
Intervention Description
Tricalcium silicate, dicalcium silicate, calcium carbonate and oxide filler, iron oxide shade and zirconium oxide
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor
Primary Outcome Measure Information:
Title
Clinical assessment
Description
Pain, tenderness, Swelling No tender on percussion. No swelling/sinus. No pathological tooth mobility.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiographically:
Description
Lamina dura, periodontal ligament space, resorption Normal periodontal ligament space. No external/internal resorption. No periapical /furcation radiolucency.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Apparently healthy children free from any known systemic diseases. Parent willing to participate in the study and signed an informed consent. Patient had at least three restorable primary molars with a caries- exposed vital pulp Exclusion Criteria: history of spontaneous pain or provoked pain. clinical signs and ̸ or symptoms suggesting a non-vital tooth such as (fistula, sinus tract, soft tissue swelling, mobility or tenderness to percussion). non-Restorable tooth pathologic or physiologic mobility
Facility Information:
Facility Name
Faculty of dentistry, Suez canal university
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars

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