Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars
Primary Purpose
Class II Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACTIVA Bioactive restoration
Compomer restoration
Sponsored by
About this trial
This is an interventional treatment trial for Class II Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Children with Class II cavities in vital primary second molars.
- Proximal enamel/dentin caries limited to outer half of dentin.
- Age ranging from 4-8 years.
- Good general health.
Exclusion Criteria:
- Spontaneous pain related to carious molars.
- Abscess or fistula on examination or during history taking.
- Tooth mobility.
- Radiographic evidence of root resorption or close shedding time.
- Lack of patient co-operation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACTIVA Test arm
Compomer Comparator arm
Arm Description
Treatment of decay in Class II second primary molars using ACTIVA restorative material.
Treatment of decay in Class II second primary molars using compomer restorative material.
Outcomes
Primary Outcome Measures
Post-operative sensitivity
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Secondary Outcome Measures
Color match
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Marginal discoloration
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Marginal adaptation (integrity)
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Surface texture
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Anatomic form
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Gross/restoration fracture
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Tooth fracture
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Secondary caries
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
Pulpal affection
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04030117
Brief Title
Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars
Official Title
Clinical and Radiographic Assessment of Bioactive Restorative Material Versus Polyacid Modified Composite Resin in Treatment of Class II Restorations in Primary Molars: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Successful restoration of cavities in primary molars can be considered challenging. It is different from restoring cavities in permanent molars because factors such as the level of co-operation of the child and the handling properties and setting time of the restorative material will have some influence on the success rate of the restoration. The ideal requirements that a filling material should possess include that it bears the occlusal force, withstands the acidic and bacterial attack, survives in the oral environment in addition to being biocompatible with the oral tissues.
In an attempt to achieve this idealism, a new class of restorative materials known as "bioactive materials" has been developed. The concept of bioactive materials was introduced in 1969 and later defined as "one that elicits a specific biological response at the interface of the material which results in the formation of a bond between tissues and the material." An example of bioactive materials is ACTIVA™ BioACTIVE (Pulpdent, USA). These materials are ionic composite resins which combine the biocompatibility, chemical bond and the ability to release fluoride of glass ionomers with the mechanical properties, esthetic and durability of composite resins.
Compomer is widely accepted as a standard restorative material for primary dentition for Class I and II cavities. Its range of success rate in Class II restorations in primary molars is 78-96%. Many randomized clinical trials have reported comparable clinical performance to composite resin with respect to color matching, marginal discoloration, anatomical form, marginal integrity and secondary caries. In comparison to glass ionomer and Resin Modified Glass Ionomer, compomers tend to have better physical properties in the primary dentition. However, their cariostatic properties didn't differ significantly from those materials.
Detailed Description
Hypothesis:
The null hypothesis is that there is no difference between using ACTIVA and Dyract® in children to restore Class II cavities in carious vital primary second molars.
Trial design:
A pilot study, parallel group, two arm.
Allocation ratio is 1:1.
Method
Intervention:
A) Diagnosis:
Diagnostic chart will be filled with personal, medical and dental history.
The intra-oral examination will be made using gloves, mask, gauze and dental mirror.
A pre-operative radiograph (bitewing) will be taken for diagnosis. b) The intervention in this pilot study will be (ACTIVA™ BioACTIVE, Pulpdent, USA) - Gp1 while the comparator will be (Dyract® DENTSPLY, Germany)- Gp2.
Three follow up visits for restoration at:
T1 (3 months), T2 (6 months) and T3 (12 months).
Same procedure in both groups will be followed:
The tooth will be anesthetized using local anesthesia, and isolated using rubber dam.
Caries will be removed.
A proximal box is prepared.
A metal matrix band is fixed around the tooth and a wedge is placed interdentally.
The restorative material chosen according to the randomization is placed in the cavity according to the manufacturer's instructions.
A post-operative digital bitewing radiograph will be taken immediately after the treatment as a base line reference and to check for voids or any defect in the restoration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTIVA Test arm
Arm Type
Experimental
Arm Description
Treatment of decay in Class II second primary molars using ACTIVA restorative material.
Arm Title
Compomer Comparator arm
Arm Type
Active Comparator
Arm Description
Treatment of decay in Class II second primary molars using compomer restorative material.
Intervention Type
Procedure
Intervention Name(s)
ACTIVA Bioactive restoration
Other Intervention Name(s)
ACTIVA Bioactive Class II restoration
Intervention Description
Removal of Class II decay in second primary molars and placement of ACTIVA restoration.
Intervention Type
Procedure
Intervention Name(s)
Compomer restoration
Other Intervention Name(s)
Compomer Class II restoration
Intervention Description
Removal of Class II decay in second primary molars and placement of Compomer restoration.
Primary Outcome Measure Information:
Title
Post-operative sensitivity
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Color match
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Marginal discoloration
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Marginal adaptation (integrity)
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Surface texture
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Anatomic form
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Gross/restoration fracture
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Tooth fracture
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Secondary caries
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Title
Pulpal affection
Description
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Secondary/recurrent caries
Description
Using standardized bite-wing radiograph to check presence or absence of secondary caries.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with Class II cavities in vital primary second molars.
Proximal enamel/dentin caries limited to outer half of dentin.
Age ranging from 4-8 years.
Good general health.
Exclusion Criteria:
Spontaneous pain related to carious molars.
Abscess or fistula on examination or during history taking.
Tooth mobility.
Radiographic evidence of root resorption or close shedding time.
Lack of patient co-operation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Moustafa
Phone
00201111254041
Email
reem.m.moustafa87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cairo University
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After thesis defense the study will be published internationally to be available for the public.
IPD Sharing Time Frame
Data will be available within one year and a half
IPD Sharing Access Criteria
Not yet
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Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars
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