Clinical trial NCT04030117: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative sensitivity
timeFrame: 12 months
Secondary outcomes:
measure: Color match
timeFrame: 12 months
measure: Marginal discoloration
timeFrame: 12 months
measure: Marginal adaptation (integrity)
timeFrame: 12 months
measure: Surface texture
timeFrame: 12 months
measure: Anatomic form
timeFrame: 12 months
measure: Gross/restoration fracture
timeFrame: 12 months
measure: Tooth fracture
timeFrame: 12 months
measure: Secondary caries
timeFrame: 12 months
measure: Pulpal affection
timeFrame: 12 months
Other outcomes:
measure: Secondary/recurrent caries
timeFrame: 12 months
Locations:
Study officials:
affiliation: Cairo University
name: Cairo University
role: PRINCIPAL_INVESTIGATOR
References: