Dental Caries in Primary MolarsCARICLAST-RCTNCT07270458
Clinical Comparison of Cariclast Gel and Rotary Drilling Technique for Caries Removal in 2d Primary Molars
A study testing cares removal using cariclast gel and Conventional Mechanical Caries Removal in people with Dental Caries in Primary Molars, run by Cairo University.
Trial summary
This randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Primary Molars
- What is being tested?
- cares removal using cariclast gel and Conventional Mechanical Caries Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- children aged 4-7 years
- in good general health, and medically free according to parent history.
- Cooperative patients
- Children whom their parents will comply with follow-ups.
- Children whom their parents who accept to sign informed consent
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- Tooth:
- Broad cavitated occlusal lesion with dentinal involvement
- (Black's Class I cavity) and occlusal access.
- Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
- The consistency of carious lesions ranges from soft to medium hard.
- Color of carious lesion ranges from light yellow to brown
Who cannot join
- Children:
- Medically or developmentally compromising conditions
- Children who will be unable to attend follow-up visits.
- Children whom their parents refuse to give written formed consent.
- Teeth:
- Cases requiring restorative treatment that is not of the Class I variety.
Show all 9Show fewer
- Extensively damaged teeth.
- Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
- Caries involving pulp or extending below the gingiva.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Pain Perception and Patient Acceptance During Chemomechanical Caries Removal Using Cariclast Versus Conventional Caries Removal in 2nd Primary Molars With Occlusal Caries in Children: A Randomized Clinical Trial
This randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. The study will evaluate and compare the pain perception, patient acceptance, and operative time associated with both techniques in children aged 5-7years.
Read the detailed description
Dental caries is one of the most common chronic diseases in children, and the management of carious lesions in primary teeth should be both effective and minimally invasive. Traditional caries removal using rotary instruments is associated with discomfort and anxiety among pediatric patients.
Chemomechanical caries removal (CMCR) agents such as Cariclast have been developed as a more conservative and less traumatic alternative. Cariclast works by softening the infected dentin chemically, allowing its gentle removal without pain or vibration.
This randomized controlled clinical trial will compare Cariclast with the conventional rotary drilling method regarding:
Pain perception assessed using the FLACC scale.
Patient acceptance evaluated using the Visual Analog Scale (VAS).
Operative time required to complete the caries removal procedure.
All procedures will be performed on cooperative children with occlusal caries in primary molars, without pulpal involvement, attending the Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.
- Conditions
- Dental Caries in Primary Molars
- Being tested
- cares removal using cariclast gel, Conventional Mechanical Caries Removal
- Keywords
- Chemomechanical caries removal, Rotary method, Sodium hypochlorite gel, caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cares removal using cariclast gelProcedure or surgery
Also called Sodium hypochlorite-based CMCR agent
Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.
Conventional Mechanical Caries RemovalProcedure or surgery
Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.
| Study group | Role | What they receive |
|---|---|---|
| cariclast group | Experimental | Participants in this arm will undergo chemomechanical caries removal using Cariclast gel (sodium hypochlorite-based CMCR agent). The gel will be applied on the carious lesion according to the manufacturer's instructions, followed by gentle removal of the softened dentin using hand excavators. Receives: Procedure: cares removal using cariclast gel |
| Conventional Mechanical Caries Removal | Active comparator | Participants in this arm will undergo conventional mechanical caries removal using a high-speed rotary handpiece under adequate water cooling. The procedure will follow standard clinical principles for removing infected dentin while maintaining a conservative approach to preserve sound tooth structure in primary molars. Receives: Procedure: Conventional Mechanical Caries Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception During Caries Removal
Pain perception will be evaluated using the Wong-Baker FACES Pain Rating Scale. Before starting caries removal, the child will be briefly shown the six facial expressions and given age-appropriate instructions to ensure proper understanding of how to express discomfort. During the procedure, immediately at the moment of peak stimulation, the child will be asked to point to the face that best reflects their pain experience. The selected score (ranging from 0 to 10) will be recorded as an objective standardized measure of procedural pain.
Measured: During the caries removal procedure (immediate intraoperative assessment)
Secondary outcomes (1)
Child Acceptance of the Caries Removal Technique
Patient acceptance will be measured immediately after completion of the caries removal procedure using a Visual Analog Scale (VAS). The scale consists of a 100-mm horizontal line with descriptors at each end indicating the extremes of comfort, ranging from "no discomfort" to "worst possible discomfort." Each child will be asked to mark a point on the line that best represents their overall comfort during the procedure. The distance in millimeters from the "no discomfort" anchor to the child's mark will be measured to quantify the level of acceptance. Higher scores indicate lower acceptance of the technique.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in Primary MolarsStudies 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran Mohamed Kamel Bayoumi, Cairo University
- Investigators
- randa youssef abdelgawad, professor, Study director, Cairo Universityrana sobhy saeed, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270458
- Sponsor's protocol ID
- NK2025-CARICLAST
- Acronym
- CARICLAST-RCT
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gupta N, Marwah N, Nigam A, Vishwanathaiah S, Alessa N, Almeslet A, Alhakami K, Dawood T, Masha FM, Maganur PC. Evaluation of Papacarie(R), Carie-Care, BRIX3000 and conventional hand instrumentation for caries removal in primary teeth: a randomized control study. J Clin Pediatr Dent. 2024 May;48(3):131-138. doi: 10.22514/jocpd.2024.066. Epub 2024 May 3.
PubMed 38755991Nagaveni, N. B., Radhika, N. B., Satisha, T. S., Ashwini, K. S., Sridhar, N., & Gupta, S. (2016). Efficacy of new chemomechanical caries removal agent compared with conventional method in primary teeth: An in vivo study. International Journal of Oral Health Sciences, 6(2), 52-58. doi: 10.4103/2231-6027.199986
Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407.
PubMed 33114249Al Agili DE. A systematic review of population-based dental caries studies among children in Saudi Arabia. Saudi Dent J. 2013 Jan;25(1):3-11. doi: 10.1016/j.sdentj.2012.10.002. Epub 2012 Nov 10.
PubMed 23960549Chaussain-Miller C, Decup F, Domejean-Orliaguet S, Gillet D, Guigand M, Kaleka R, Laboux O, Lafont J, Medioni E, Serfaty R, Toumelin-Chemla F, Tubiana J, Lasfargues JJ. Clinical evaluation of the Carisolv chemomechanical caries removal technique according to the site/stage concept, a revised caries classification system. Clin Oral Investig. 2003 Mar;7(1):32-7. doi: 10.1007/s00784-003-0196-5. Epub 2003 Feb 20.
PubMed 12673435Kotb RM, Abdella AA, El Kateb MA, Ahmed AM. Clinical evaluation of Papacarie in primary teeth. J Clin Pediatr Dent. 2009 Winter;34(2):117-23. doi: 10.17796/jcpd.34.2.f312p36g18463716.
PubMed 20297701
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pain Perception and Patient Acceptance During Chemomechanical Caries Removal Using Cariclast Versus Conventional Caries Removal in 2nd Primary Molars With Occlusal Caries in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07270458
- Acronym / sponsor ID
- CARICLAST-RCT / NK2025-CARICLAST
- Conditions
- Dental Caries in Primary Molars
- Keywords
- Chemomechanical caries removal, Rotary method, Sodium hypochlorite gel, caries removal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Dec 2025 (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 randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. The study will evaluate and compare the pain perception, patient acceptance, and operative time associated with both techniques in children aged 5-7years.
Detailed description
Dental caries is one of the most common chronic diseases in children, and the management of carious lesions in primary teeth should be both effective and minimally invasive. Traditional caries removal using rotary instruments is associated with discomfort and anxiety among pediatric patients.
Chemomechanical caries removal (CMCR) agents such as Cariclast have been developed as a more conservative and less traumatic alternative. Cariclast works by softening the infected dentin chemically, allowing its gentle removal without pain or vibration.
This randomized controlled clinical trial will compare Cariclast with the conventional rotary drilling method regarding:
Pain perception assessed using the FLACC scale.
Patient acceptance evaluated using the Visual Analog Scale (VAS).
Operative time required to complete the caries removal procedure.
All procedures will be performed on cooperative children with occlusal caries in primary molars, without pulpal involvement, attending the Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cariclast group | Experimental | Procedure: cares removal using cariclast gelParticipants in this arm will undergo chemomechanical caries removal using Cariclast gel (sodium hypochlorite-based CMCR agent). The gel will be applied on the carious lesion according to the manufacturer's instructions, followed by gentle removal of the softened dentin using hand excavators. |
| Conventional Mechanical Caries Removal | Active comparator | Procedure: Conventional Mechanical Caries RemovalParticipants in this arm will undergo conventional mechanical caries removal using a high-speed rotary handpiece under adequate water cooling. The procedure will follow standard clinical principles for removing infected dentin while maintaining a conservative approach to preserve sound tooth structure in primary molars. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children:
- Broad cavitated occlusal lesion with dentinal involvement
- (Black's Class I cavity) and occlusal access.
- Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
- The consistency of carious lesions ranges from soft to medium hard.
Key exclusion criteria (9 listed)
- Children:
- Cases requiring restorative treatment that is not of the Class I variety.
- Extensively damaged teeth.
- Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
- Caries involving pulp or extending below the gingiva.
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 |
|---|---|---|
| cares removal using cariclast gelAlso: Sodium hypochlorite-based CMCR agentChemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments. | Procedure or surgery | cariclast group |
| Conventional Mechanical Caries RemovalConventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars. | Procedure or surgery | Conventional Mechanical Caries Removal |
Primary outcome
Pain Perception During Caries Removal
Time frame: During the caries removal procedure (immediate intraoperative assessment)
Pain perception will be evaluated using the Wong-Baker FACES Pain Rating Scale. Before starting caries removal, the child will be briefly shown the six facial expressions and given age-appropriate instructions to ensure proper understanding of how to express discomfort. During the procedure, immediately at the moment of peak stimulation, the child will be asked to point to the face that best reflects their pain experience. The selected score (ranging from 0 to 10) will be recorded as an objective standardized measure of procedural pain.
1 secondary outcome
Child Acceptance of the Caries Removal Technique
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 38755991Gupta N, Marwah N, Nigam A, Vishwanathaiah S, Alessa N, Almeslet A, Alhakami K, Dawood T, Masha FM, Maganur PC. Evaluation of Papacarie(R), Carie-Care, BRIX3000 and conventional hand instrumentation for caries removal in primary teeth: a randomized control study. J Clin Pediatr Dent. 2024 May;48(3):131-138. doi: 10.22514/jocpd.2024.066. Epub 2024 May 3.
- Results publicationNagaveni, N. B., Radhika, N. B., Satisha, T. S., Ashwini, K. S., Sridhar, N., & Gupta, S. (2016). Efficacy of new chemomechanical caries removal agent compared with conventional method in primary teeth: An in vivo study. International Journal of Oral Health Sciences, 6(2), 52-58. doi: 10.4103/2231-6027.199986
- Results publication: PubMed 33114249Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407.
- Results publication: PubMed 23960549Al Agili DE. A systematic review of population-based dental caries studies among children in Saudi Arabia. Saudi Dent J. 2013 Jan;25(1):3-11. doi: 10.1016/j.sdentj.2012.10.002. Epub 2012 Nov 10.
- Results publication: PubMed 12673435Chaussain-Miller C, Decup F, Domejean-Orliaguet S, Gillet D, Guigand M, Kaleka R, Laboux O, Lafont J, Medioni E, Serfaty R, Toumelin-Chemla F, Tubiana J, Lasfargues JJ. Clinical evaluation of the Carisolv chemomechanical caries removal technique according to the site/stage concept, a revised caries classification system. Clin Oral Investig. 2003 Mar;7(1):32-7. doi: 10.1007/s00784-003-0196-5. Epub 2003 Feb 20.
- Results publication: PubMed 20297701Kotb RM, Abdella AA, El Kateb MA, Ahmed AM. Clinical evaluation of Papacarie in primary teeth. J Clin Pediatr Dent. 2009 Winter;34(2):117-23. doi: 10.17796/jcpd.34.2.f312p36g18463716.
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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.
randa youssef abdelgawad, professor study director
Cairo University
rana sobhy saeed study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing cares removal using cariclast gel and Conventional Mechanical Caries Removal in people with Dental Caries in Primary Molars, 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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact noran mohamed kamel, bechelor (011464949811, mnourr211@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception During Caries Removal (time frame: During the caries removal procedure (immediate intraoperative assessment)). 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 NCT07270458, which also lists 6 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 21 Apr 2026.