Class II Dental CariesNCT04030117
Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars
A study testing ACTIVA Bioactive restoration and Compomer restoration in people with Class II Dental Caries, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Dental Caries
- What is being tested?
- ACTIVA Bioactive restoration and Compomer restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Class II Dental Caries
- Being tested
- ACTIVA Bioactive restoration, Compomer restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVA Bioactive restorationProcedure or surgery
Also called ACTIVA Bioactive Class II restoration
Removal of Class II decay in second primary molars and placement of ACTIVA restoration.
Compomer restorationProcedure or surgery
Also called Compomer Class II restoration
Removal of Class II decay in second primary molars and placement of Compomer restoration.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVA Test arm | Experimental | Treatment of decay in Class II second primary molars using ACTIVA restorative material. Receives: Procedure: ACTIVA Bioactive restoration |
| Compomer Comparator arm | Active comparator | Treatment of decay in Class II second primary molars using compomer restorative material. Receives: Procedure: Compomer restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study startSep 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohsen Ahmed Moustafa, Cairo University
- Investigators
- Cairo University, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030117
- Sponsor's protocol ID
- 19121987
- Status last verified
- Jul 2019
- First submitted
- 18 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After thesis defense the study will be published internationally to be available for the public.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04030117
- Acronym / sponsor ID
- 19121987
- Conditions
- Class II Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVA Test arm | Experimental | Procedure: ACTIVA Bioactive restorationTreatment of decay in Class II second primary molars using ACTIVA restorative material. |
| Compomer Comparator arm | Active comparator | Procedure: Compomer restorationTreatment of decay in Class II second primary molars using compomer restorative material. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVA Bioactive restorationAlso: ACTIVA Bioactive Class II restorationRemoval of Class II decay in second primary molars and placement of ACTIVA restoration. | Procedure or surgery | ACTIVA Test arm |
| Compomer restorationAlso: Compomer Class II restorationRemoval of Class II decay in second primary molars and placement of Compomer restoration. | Procedure or surgery | Compomer Comparator arm |
Primary outcome
Post-operative sensitivity
Time frame: 12 months
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).
9 secondary outcomes
Color match
Time frame: 12 months
Marginal discoloration
Time frame: 12 months
Marginal adaptation (integrity)
Time frame: 12 months
Surface texture
Time frame: 12 months
Anatomic form
Time frame: 12 months
Gross/restoration fracture
Time frame: 12 months
Tooth fracture
Time frame: 12 months
Secondary caries
Time frame: 12 months
Pulpal affection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Yes. After thesis defense the study will be published internationally to be available for the public.
Related trials for Class II Dental Caries
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Clinical Performance of Different Ion-Releasing Restorative Systems in Class II Cavities
Dental Caries
Active, not recruiting
Bioactive Restorative Materials for Class II Restorations
Bioactive Dental Restorative Materials, Class II Dental Caries
Recruiting
Clinical Performance of Bioactive Bulk-Fill in Class II Restorations
Dental Caries
Not yet recruiting
Bulk-Fill Composite Restorations: Clinical Evaluation
Composite Resins, Dental Caries Class II
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cairo University principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVA Bioactive restoration and Compomer restoration in people with Class II Dental Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Moustafa (00201111254041, reem.m.moustafa87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative sensitivity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.