Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars

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

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.

Study Overview

• Status: Unknown
• Conditions: Class II Dental Caries
• Intervention / Treatment: Procedure: ACTIVA Bioactive restoration; Procedure: Compomer restoration

Detailed Description

1. 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.

2. Trial design:

   • A pilot study, parallel group, two arm.
   • Allocation ratio is 1:1.
3. 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:

1. The tooth will be anesthetized using local anesthesia, and isolated using rubber dam.
2. Caries will be removed.
3. A proximal box is prepared.
4. A metal matrix band is fixed around the tooth and a wedge is placed interdentally.
5. The restorative material chosen according to the randomization is placed in the cavity according to the manufacturer's instructions.
6. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem Moustafa; Phone Number: 00201111254041; Email: reem.m.moustafa87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with Class II cavities in vital primary second molars.
2. Proximal enamel/dentin caries limited to outer half of dentin.
3. Age ranging from 4-8 years.
4. Good general health.

Exclusion Criteria:

1. Spontaneous pain related to carious molars.
2. Abscess or fistula on examination or during history taking.
3. Tooth mobility.
4. Radiographic evidence of root resorption or close shedding time.
5. Lack of patient co-operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTIVA Test arm; Treatment of decay in Class II second primary molars using ACTIVA restorative material.	Procedure: ACTIVA Bioactive restoration; Removal of Class II decay in second primary molars and placement of ACTIVA restoration.; Other Names: ACTIVA Bioactive Class II restoration
Active Comparator: Compomer Comparator arm; Treatment of decay in Class II second primary molars using compomer restorative material.	Procedure: Compomer restoration; Removal of Class II decay in second primary molars and placement of Compomer restoration.; Other Names: Compomer Class II restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
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).	12 months
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).	12 months
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).	12 months
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).	12 months
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).	12 months
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).	12 months
Secondary caries	Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).	12 months
Pulpal affection	Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration and (C) = clinically unacceptable restorations (failure).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary/recurrent caries	Using standardized bite-wing radiograph to check presence or absence of secondary caries.	12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: cairo university, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 19121987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• 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