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

NCT04030117 | Unknown

• 1 other identifier: 19121987
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Class II Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Color match

  12 months

• Marginal discoloration

  12 months

• Marginal adaptation (integrity)

  12 months

• Surface texture

  12 months

• Anatomic form

  12 months

Other Outcomes (1)

• Secondary/recurrent caries

  12 months

Study Arms (2)

ACTIVA Test arm

EXPERIMENTAL

Treatment of decay in Class II second primary molars using ACTIVA restorative material.

Procedure: ACTIVA Bioactive restoration

Compomer Comparator arm

ACTIVE COMPARATOR

Treatment of decay in Class II second primary molars using compomer restorative material.

Procedure: Compomer restoration

Interventions

ACTIVA Bioactive restoration PROCEDURE

Removal of Class II decay in second primary molars and placement of ACTIVA restoration.

Also known as: ACTIVA Bioactive Class II restoration

ACTIVA Test arm

Compomer restoration PROCEDURE

Removal of Class II decay in second primary molars and placement of Compomer restoration.

Also known as: Compomer Class II restoration

Compomer Comparator arm

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Cairo University

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Moustafa

CONTACT

00201111254041; reem.m.moustafa87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within one year and a half
• Access Criteria: Not yet