Dental Caries in ChildrenNCT06412731
Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
A study testing Cera-bur, Brix3000 and E-SDF in people with Dental Caries in Children, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes: 1. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Cera-bur, Brix3000 and E-SDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 2 Jan 2024to 1 Jul 2024
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth.
- These lesions should affect the dentin but not expose the pulp.
- The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization
Who cannot join
- Children were excluded if parents were unwilling to be assigned to any of the approaches
- Children that had any abnormal medical condition or silver or papain allergy
- Chose molars with clinical or radiographic signals of pulp involvement
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Dentistry, Mustansiriyah University
Baghdad, Al-karkh, 10011
About this study
This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:
- Arrestment of caries lesion and the emergence of a new one
- Time required for the treatment
- Adverse events
- Children's anxiety
Read the detailed description
The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp.
The purpose of this research was to evaluate three minimally invasive therapies via the assessment of:
- Duration of treatment
- (feeling of pain) and the need for anesthetic
- Incidents with negative outcomes that have been officially documented
- Filling material adhesiveness fellow up
The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect
Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur)
Setting:
Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions.
- Conditions
- Dental Caries in Children
- Being tested
- Cera-bur, Brix3000, E-SDF
- Keywords
- CMCR, SDF, Ceramic bur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cera-burOther
Also called Ceramic bur
Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material
Brix3000Other
Also called Papain-based CMCR
Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material
E-SDFOther
Also called 38% Silver Diamine fluoride
Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling
| Study group | Role | What they receive |
|---|---|---|
| Ceramic bur (Cerabur) C | Active comparator | Cera bur (Ceramic Bur) Komet, Lemgo, Germany Receives: Other: Cera-bur |
| Silver Diamine Fluoride (e-SDF) S | Active comparator | e-SDF (SDF 38%) E-kids, India Receives: Other: E-SDF |
| CMCR gel (Brix3000) B | Active comparator | Brix3000 (Papain based gel) S.R.L., Argentina Receives: Other: Brix3000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
The following adverse events will be investigated: Pain, sensitivity, tooth discoloration, burning in the mouth, allergy altered taste of food, irritation of the gums or mucosa
Measured: during the first two weeks
Filling fellow up
The evaluation was done using the community periodontal index (CPI)-probe (WHO-probe) and a dental mirror. The treated lesions were classified according to the evaluation scores which were modified from those used by Francis et al.: score 1 - the restoration intact, covering all pits and fissures; score 2 - the restoration partially lost, the tooth is sound (no active/soft caries); score 3 - the restoration partially lost, the tooth is carious(active/soft caries); score 4 - the restoration completely lost, the tooth is sound; and score 5 - the restoration completely lost, the tooth is carious. The tooth was considered sound if its surface felt hard and shiny
Measured: after 3 months
Secondary outcomes (2)
anxiety level
Anxiety level prescribed by the patient using a facial image scale to measure the children' anxiety. Each kid was instructed to indicate the facial expression that most accurately conveyed their current emotional state, which may be categorized as either (very happy; happy; neutral; unhappy; or very unhappy
Measured: immediately after the procedure
Time
the time required for the treatment in each group using a digital timer A digital timer which triggers as soon as the tooth brushing starts. During the first appointment starting from dental caries removal until sound dentin reached before Glass ionomer filling placement,
Measured: This will take about from 5 to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Jan 2024
- Primary completion23 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alhamzah thaer hasan Ankaz, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412731
- Sponsor's protocol ID
- MUPRU004
- Status last verified
- May 2025
- First submitted
- 25 Apr 2024
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Satyarup D, Mohanty S, Nagarajappa R, Mahapatra I, Dalai RP. Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):217-223. doi: 10.17219/dmp/143547.
PubMed 35506381Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.
PubMed 31279925
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
- ClinicalTrials.gov ID
- NCT06412731
- Acronym / sponsor ID
- MUPRU004
- Conditions
- Dental Caries in Children
- Keywords
- CMCR, SDF, Ceramic bur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 May 2024 (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.
This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:
- Arrestment of caries lesion and the emergence of a new one
- Time required for the treatment
- Adverse events
- Children's anxiety
Detailed description
The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp.
The purpose of this research was to evaluate three minimally invasive therapies via the assessment of:
- Duration of treatment
- (feeling of pain) and the need for anesthetic
- Incidents with negative outcomes that have been officially documented
- Filling material adhesiveness fellow up
The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect
Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur)
Setting:
Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ceramic bur (Cerabur) C | Active comparator | Other: Cera-burCera bur (Ceramic Bur) Komet, Lemgo, Germany |
| Silver Diamine Fluoride (e-SDF) S | Active comparator | Other: E-SDFe-SDF (SDF 38%) E-kids, India |
| CMCR gel (Brix3000) B | Active comparator | Other: Brix3000Brix3000 (Papain based gel) S.R.L., Argentina |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth.
- These lesions should affect the dentin but not expose the pulp.
- The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization
Key exclusion criteria (3 listed)
- Children were excluded if parents were unwilling to be assigned to any of the approaches
- Children that had any abnormal medical condition or silver or papain allergy
- Chose molars with clinical or radiographic signals of pulp involvement
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 |
|---|---|---|
| Cera-burAlso: Ceramic burDental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material | Other | Ceramic bur (Cerabur) C |
| Brix3000Also: Papain-based CMCRChemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material | Other | CMCR gel (Brix3000) B |
| E-SDFAlso: 38% Silver Diamine fluorideArresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling | Other | Silver Diamine Fluoride (e-SDF) S |
Primary outcome
Adverse event
Time frame: during the first two weeks
The following adverse events will be investigated: Pain, sensitivity, tooth discoloration, burning in the mouth, allergy altered taste of food, irritation of the gums or mucosa
Filling fellow up
Time frame: after 3 months
The evaluation was done using the community periodontal index (CPI)-probe (WHO-probe) and a dental mirror. The treated lesions were classified according to the evaluation scores which were modified from those used by Francis et al.: score 1 - the restoration intact, covering all pits and fissures; score 2 - the restoration partially lost, the tooth is sound (no active/soft caries); score 3 - the restoration partially lost, the tooth is carious(active/soft caries); score 4 - the restoration completely lost, the tooth is sound; and score 5 - the restoration completely lost, the tooth is carious. The tooth was considered sound if its surface felt hard and shiny
2 secondary outcomes
anxiety level
Time frame: immediately after the procedure
Time
Time frame: This will take about from 5 to 30 minutes
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 8 May 2025.
- Results publication: PubMed 35506381Satyarup D, Mohanty S, Nagarajappa R, Mahapatra I, Dalai RP. Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):217-223. doi: 10.17219/dmp/143547.
- Results publication: PubMed 31279925Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.
- Evaluation of the Efficacy of Caries Removal Using Papain Gel (Brix 3000) and Smart Preparation Bur(in vivo Comparative Study)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cera-bur, Brix3000 and E-SDF in people with Dental Caries in Children, run by Al-Mustansiriyah University at 1 site in Iraq.
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 3 inclusion and 3 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 8 May 2025. 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 Iraq. 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.
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?
Adverse event (time frame: during the first two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412731, which also lists 2 linked publications.
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 8 May 2025.