Deep CariesPhase 3NCT02868918
Evaluation of Biodentine Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions
A Phase 3 study testing biodentine, glass ionomer cement and DigoraH optium in people with Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- biodentine, glass ionomer cement and DigoraH optium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Mar 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients male or female older than 18 y in good general health
- A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
- Clinical symptoms of reversible pulpitis
- Positive pulp response to electric pulp test or thermal stimulation
- No PA changes viewed on PA radiograph
Who cannot join
- Clinical symptoms of irreversible pulpitis requiring endodontic treatment
- Presence of fistulas or swelling
- Mobile teeth or tenderness to percussion
- Anterior teeth with aesthetic concerns
- Pregnant women, in view of requirements for radiographs
- Patients younger than 18 y
- Patients unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial
The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.
Read the detailed description
Roles and responsibilities:
- Omnia Magdy Moustafa (O.M.) Operator, data entry \& corresponding author; Assistant lecturer ,
- Mohmed Riad Farid (M.R.) Main supervisor, data monitoring \& auditing; Professor, Conservative Dentistry
- Rasha Raffat (R.R.) Co-supervisor, data entry \& auditing; Lecturer, Conservative Dentistry Department
- Amir Hafez Ibrahim (A.H.), *Mohamed Refaat El-Bialy (M.E.) (A.H) Lecturer, Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University,(M.E.) Assistant lecturer , Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University outcome assessors and data collection.
- Omar Shalaan (O.S.) Demonstrator, Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University, for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.
Interventions:
- Pre-operative clinical assessment :
- Thermal testing using Refrigerant spray
- percussion test
- Palpation and clinical examination
- peri-apical radiographs using digital radiograph
- Caries removal procedure:
Local anesthesia will be given to the patient then complete isolation to the tooth using rubber dame the operator O.M. will open the enamel Then in caries removal from the walls carbon-steel rose-head bur. Finally the deeper caries will be removed using spoon excavator
- Intervention : Biodentine™ (Septodont, St. Maur-des-Fossés, France) The material will be applied according to manufacturer instructions
- Comparator: GC Fuji IX GP (GC America Inc, Alsip, IL, USA) The material will be applied according to manufacturer instructions
- Final restoration application:
Filtek™ Z250 Universal Restorative (3M Canada, London, Ontario Canada)
-Adhesive system: Scotchbond Universal Etchant (3M ESPE, St. Paul MN, USA) \& Single Bond Universal adhesive (3M ESPE, St. Paul MN, USA).
- The material will be applied according to manufacturer instruction
- Conditions
- Deep Caries
- Being tested
- biodentine, glass ionomer cement, DigoraH optium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biodentineDrug
Also called tricalcium silicate
tricalcium silicate cement used to replace the carious dentin
glass ionomer cementDrug
Also called Fuji ix
high viscosity glass ionomer used as a base material
DigoraH optiumDevice
Also called digital radiography
digital Xray for follow up
| Study group | Role | What they receive |
|---|---|---|
| biodentine | Experimental | bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention Receives: Drug: biodentine; Device: DigoraH optium |
| glass ionomer cement | Active comparator | high viscosity glass ionomer used as a base material comparator other name : - fuji ix Receives: Drug: glass ionomer cement; Device: DigoraH optium |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hypersensitivity using yes or no questionnaire
Measured: 6 months
Secondary outcomes (1)
Biocompatibility of biodentine using digital X-ray
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Magdy Moustafa, Cairo University
- Investigators
- Ahmed Elkhadem, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868918
- Sponsor's protocol ID
- CEBD-CU-2016-08-174
- Status last verified
- Sep 2022
- First submitted
- 6 Aug 2016
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02868918
- Acronym / sponsor ID
- CEBD-CU-2016-08-174
- Conditions
- Deep Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.
Detailed description
Roles and responsibilities:
- Omnia Magdy Moustafa (O.M.) Operator, data entry \& corresponding author; Assistant lecturer ,
- Mohmed Riad Farid (M.R.) Main supervisor, data monitoring \& auditing; Professor, Conservative Dentistry
- Rasha Raffat (R.R.) Co-supervisor, data entry \& auditing; Lecturer, Conservative Dentistry Department
- Amir Hafez Ibrahim (A.H.), *Mohamed Refaat El-Bialy (M.E.) (A.H) Lecturer, Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University,(M.E.) Assistant lecturer , Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University outcome assessors and data collection.
- Omar Shalaan (O.S.) Demonstrator, Conservative Dentistry Department, Faculty of Oral \& Dental Medicine Cairo University, for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.
Interventions:
- Pre-operative clinical assessment :
- Thermal testing using Refrigerant spray
- percussion test
- Palpation and clinical examination
- peri-apical radiographs using digital radiograph
- Caries removal procedure:
Local anesthesia will be given to the patient then complete isolation to the tooth using rubber dame the operator O.M. will open the enamel Then in caries removal from the walls carbon-steel rose-head bur. Finally the deeper caries will be removed using spoon excavator
- Intervention : Biodentine™ (Septodont, St. Maur-des-Fossés, France) The material will be applied according to manufacturer instructions
- Comparator: GC Fuji IX GP (GC America Inc, Alsip, IL, USA) The material will be applied according to manufacturer instructions
- Final restoration application:
Filtek™ Z250 Universal Restorative (3M Canada, London, Ontario Canada)
-Adhesive system: Scotchbond Universal Etchant (3M ESPE, St. Paul MN, USA) \& Single Bond Universal adhesive (3M ESPE, St. Paul MN, USA).
- The material will be applied according to manufacturer instruction
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biodentine | Experimental | Drug: biodentine, Device: DigoraH optiumbioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention |
| glass ionomer cement | Active comparator | Drug: glass ionomer cement, Device: DigoraH optiumhigh viscosity glass ionomer used as a base material comparator other name : - fuji ix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients male or female older than 18 y in good general health
- A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
- Clinical symptoms of reversible pulpitis
- Positive pulp response to electric pulp test or thermal stimulation
- No PA changes viewed on PA radiograph
Key exclusion criteria (7 listed)
- Clinical symptoms of irreversible pulpitis requiring endodontic treatment
- Presence of fistulas or swelling
- Mobile teeth or tenderness to percussion
- Anterior teeth with aesthetic concerns
- Pregnant women, in view of requirements for radiographs
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 |
|---|---|---|
| biodentineAlso: tricalcium silicatetricalcium silicate cement used to replace the carious dentin | Drug | biodentine |
| glass ionomer cementAlso: Fuji ixhigh viscosity glass ionomer used as a base material | Drug | glass ionomer cement |
| DigoraH optiumAlso: digital radiographydigital Xray for follow up | Device | biodentine, glass ionomer cement |
Primary outcome
postoperative hypersensitivity using yes or no questionnaire
Time frame: 6 months
1 secondary outcome
Biocompatibility of biodentine using digital X-ray
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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.
Ahmed Elkhadem, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biodentine, glass ionomer cement and DigoraH optium in people with Deep Caries, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative hypersensitivity using yes or no questionnaire (time frame: 6 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 15 Sep 2022.