Dental CariesNCT05733923
Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal
A study testing Traditional Escavation, Excavation with Sodium Hypochlorite Gel 2.5%. and Excavation with Papacarie Duo in people with Dental Caries, run by Damascus University at 1 site in Syria.
Trial summary
The evolution of conservative dentistry that adopts the preservation of tooth structure and affected dentin that can remineralize and save the pulp from exposure, in addition to pain and fear that companies' traditional caries removal methods had led to the development of chemomechanical caries removal materials… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Traditional Escavation, Excavation with Sodium Hypochlorite Gel 2.5%. and Excavation with Papacarie Duo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSyria
- Study dates
- 25 Feb 2023to 15 May 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Wide carious lesion (Class 1 Black) on Molars at the middle third of dentine confirmed with a periapical x-ray
- No pulp involvement is assured with a periapical radiograph.
- Good oral hygiene
- Cooperated patient.
- No oral diseases.
Who cannot join
- Pulp exposure or bleeding during excavation.
- Pregnancy
- Systematic diseases
- Gingival and periodontal involvement.
- Lack of patient cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Papain-based Materials Compared With NaOCl-based Materials in Chemo-mechanical Caries Removal: A Randomized Controlled Trial
- The evolution of conservative dentistry that adopts the preservation of tooth structure and affected dentin that can remineralize and save the pulp from exposure, in addition to pain and fear that companies' traditional caries removal methods had led to the development of chemomechanical caries removal materials (CMCR).
The old generations of CMCR agents were NaOcl-based materials which have disadvantages such as odor taste, Unpleasant smell, high cost, Limited shelf life, and time consumption.
Read more
- All of the reasons described led to a new generation of CMCR materials depending on Enzymes such as Papain.
Brix3000 and Papacarie duo are Papain-based materials with promising effects in caries removal and fewer disadvantages.
Selecti-solve is a dental gel whose active ingredient is papain enzyme, it removes dental caries without the need for anesthesia and is selective for the infected dentin layer only which avoids the unnecessary loss of dentin, enamel breaking, and pulp exposure.
This study aims to evaluate the efficacy of Papain-based materials compared to old NAOcl-Based materials in reducing the disadvantages of CMCR agents.
Read the detailed description
In previous literature, there has not been any study that compared the whole group of chemo-mechanical caries removal materials with such a unique collection of Papain-based CMCR agents.
Papain-based agents could be promising materials in the evolution of Atraumatic Restorative treatment (ART) and Chemomechanical Caries removal methods that support conservative dentistry and the conservation of tooth structure and pulp vitality.
Brix3000 has EBE technology (Encapsulating Buffer Emulsion) that claims to elevate the efficiency of Papain Enzyme and permits the use of a higher concentration of Papain 3,000 U/mg in the whole material (10%).
Papacarie Duo has a unique combination of the main component of Papain Enzyme 6,000 U/mg and a small percentage of chloramine t that claims to increase efficiency and reduce the side effect of chloramine-based CMCR materials.
Selecti-solve is a new material that consists of Papain as the main product and has promising effects in chemo-mechanical caries removal methods.
- Conditions
- Dental Caries
- Being tested
- Traditional Escavation, Excavation with Sodium Hypochlorite Gel 2.5%., Excavation with Papacarie Duo, Excavation with Brix3000, Excavation with Selecti-solve
- Keywords
- Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional EscavationProcedure or surgery
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling.
- Group 6: 15 carious teeth will be excavated chemo-mechanically using Selecti-solve.
Excavation with Sodium Hypochlorite Gel 2.5%.Procedure or surgery
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using Sodium Hypochlorite Gel 2.5%.
Excavation with Papacarie DuoProcedure or surgery
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Papacarie Duo.
Excavation with Brix3000Procedure or surgery
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Brix3000.
Excavation with Selecti-solveProcedure or surgery
Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Selecti-solve.
| Study group | Role | What they receive |
|---|---|---|
| Traditional excavation | Active comparator | Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling. Receives: Procedure: Traditional Escavation |
| Sodium Hypochlorite CMCR | Experimental | chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%. Receives: Procedure: Excavation with Sodium Hypochlorite Gel 2.5%. |
| Papacarie duo CMCR | Experimental | chemomechanical caries removal using Papacarie duo. Receives: Procedure: Excavation with Papacarie Duo |
| Selecti-solve CMCR | Experimental | chemomechanical caries removal using Selecti-solve Gel. Receives: Procedure: Excavation with Brix3000 |
| Brix3000 CMCR | Experimental | chemomechanical caries removal using Brix3000. Receives: Procedure: Excavation with Selecti-solve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in caries removal by a detecting dye
The efficacy of caries removal will be assessed by a sharp probe aided by Caries Detector dye.
The Cavity will be inspected after every application by a sharp probe to feel any tacky sensation in dentin, when it is all hard dentin, caries detector dye will be applied to aid the investigation.
Caries detector dye will be left for 10 seconds and then rinsed with water, it will stain the organic matrix of less mineralized dentin so the cavity should be stained homogeneously so high-intensity colored spots refer to infected dentin and it will be removed.
Measured: After procedure completion, which is expected to be within 20 minutes on average.
Secondary outcomes (2)
Time required for caries removal
Time from the beginning of the caries excavation to the end of the process will be recorded in minutes using a stopwatch.
Measured: After procedure completion, which is expected to be within 20 minutes on average.
Pain perception during caries removal
Visual analog scale (VAS) will be used to evaluate the pain perception during the procedure of caries removal.
The patient will be asked to choose a number from 0 to 10 matching the intensity of his or her pain experience during the procedure.
The higher the score, the more painful the procedure is.
Measured: After procedure completion, which is expected to be within 20 minutes on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start25 Feb 2023
- Primary completion15 Oct 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Souad Abboud, DDS MSc PhD, Study chair, Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, DamascusMHD Baraa Alsayed, DDS, Principal investigator, MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733923
- Sponsor's protocol ID
- UDDS-OperativeDent-01-2023
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. Comparison of two minimally invasive restorative techniques in improving the oral health-related quality of life of pregnant women: a six months randomized controlled trial. BMC Oral Health. 2021 Apr 30;21(1):221. doi: 10.1186/s12903-021-01581-5.
PubMed 33931037AlHumaid J, Al-Harbi F, El Tantawi M, Elembaby A. X-ray microtomography assessment of Carisolv and Papacarie effect on dentin mineral density and amount of removed tissue. Acta Odontol Scand. 2018 May;76(4):236-240. doi: 10.1080/00016357.2017.1406614. Epub 2017 Nov 21.
PubMed 29161950Cardoso 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 33114249de Souza TF, Martins ML, Tavares-Silva CM, Fonseca-Goncalves A, Maia LC. Treatment time, pain experience and acceptability of the technique for caries removal in primary teeth using the ART approach with or without Brix3000 papain gel: a preliminary randomised controlled clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):777-785. doi: 10.1007/s40368-021-00669-4. Epub 2021 Oct 2.
PubMed 34599744Divya G, Prasad MG, Vasa AA, Vasanthi D, Ramanarayana B, Mynampati P. Evaluation of the Efficacy of Caries Removal Using Polymer Bur, Stainless Steel Bur, Carisolv, Papacarie - An Invitro Comparative Study. J Clin Diagn Res. 2015 Jul;9(7):ZC42-6. doi: 10.7860/JCDR/2015/12705.6202. Epub 2015 Jul 1.
PubMed 26393204Santos TML, Bresciani E, Matos FS, Camargo SEA, Hidalgo APT, Rivera LML, Bernardino IM, Paranhos LR. Comparison between conventional and chemomechanical approaches for the removal of carious dentin: an in vitro study. Sci Rep. 2020 May 15;10(1):8127. doi: 10.1038/s41598-020-65159-x.
PubMed 32415190Katiyar A, Gupta S, Gupta K, Sharma K, Tripathi B, Sharma N. Comparative Evaluation of Chemo-mechanical and Rotary-mechanical Methods in Removal of Caries with Respect to Time Consumption and Pain Perception in Pediatrc Dental Patients. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):115-119. doi: 10.5005/jp-journals-10005-1896.
PubMed 34326596Mancini L, Pisaneschi A, Mancini V, Ginoble M, Quinzi V, Marchetti E, Marzo G. BRIX3000(R) Papain Gel for Cavity Treatment in the Adult Patient. Case Rep Dent. 2021 Jun 12;2021:6624825. doi: 10.1155/2021/6624825. eCollection 2021.
PubMed 34194848Matsumoto SF, Motta LJ, Alfaya TA, Guedes CC, Fernandes KP, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo: randomized longitudinal clinical trial. Indian J Dent Res. 2013 Jul-Aug;24(4):488-92. doi: 10.4103/0970-9290.118393.
PubMed 24047844
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Papain-based Materials Compared With NaOCl-based Materials in Chemo-mechanical Caries Removal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05733923
- Acronym / sponsor ID
- UDDS-OperativeDent-01-2023
- Conditions
- Dental Caries
- Keywords
- Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 17 Feb 2023 (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.
- The evolution of conservative dentistry that adopts the preservation of tooth structure and affected dentin that can remineralize and save the pulp from exposure, in addition to pain and fear that companies' traditional caries removal methods had led to the development of chemomechanical caries removal materials (CMCR).
The old generations of CMCR agents were NaOcl-based materials which have disadvantages such as odor taste, Unpleasant smell, high cost, Limited shelf life, and time consumption.
- All of the reasons described led to a new generation of CMCR materials depending on Enzymes such as Papain.
Brix3000 and Papacarie duo are Papain-based materials with promising effects in caries removal and fewer disadvantages.
Selecti-solve is a dental gel whose active ingredient is papain enzyme, it removes dental caries without the need for anesthesia and is selective for the infected dentin layer only which avoids the unnecessary loss of dentin, enamel breaking, and pulp exposure.
This study aims to evaluate the efficacy of Papain-based materials compared to old NAOcl-Based materials in reducing the disadvantages of CMCR agents.
Detailed description
In previous literature, there has not been any study that compared the whole group of chemo-mechanical caries removal materials with such a unique collection of Papain-based CMCR agents.
Papain-based agents could be promising materials in the evolution of Atraumatic Restorative treatment (ART) and Chemomechanical Caries removal methods that support conservative dentistry and the conservation of tooth structure and pulp vitality.
Brix3000 has EBE technology (Encapsulating Buffer Emulsion) that claims to elevate the efficiency of Papain Enzyme and permits the use of a higher concentration of Papain 3,000 U/mg in the whole material (10%).
Papacarie Duo has a unique combination of the main component of Papain Enzyme 6,000 U/mg and a small percentage of chloramine t that claims to increase efficiency and reduce the side effect of chloramine-based CMCR materials.
Selecti-solve is a new material that consists of Papain as the main product and has promising effects in chemo-mechanical caries removal methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Traditional excavation | Active comparator | Procedure: Traditional EscavationMechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling. |
| Sodium Hypochlorite CMCR | Experimental | Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%. |
| Papacarie duo CMCR | Experimental | Procedure: Excavation with Papacarie Duochemomechanical caries removal using Papacarie duo. |
| Selecti-solve CMCR | Experimental | Procedure: Excavation with Brix3000chemomechanical caries removal using Selecti-solve Gel. |
| Brix3000 CMCR | Experimental | Procedure: Excavation with Selecti-solvechemomechanical caries removal using Brix3000. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Wide carious lesion (Class 1 Black) on Molars at the middle third of dentine confirmed with a periapical x-ray
- No pulp involvement is assured with a periapical radiograph.
- Good oral hygiene
- Cooperated patient.
- No oral diseases.
Key exclusion criteria (5 listed)
- Pulp exposure or bleeding during excavation.
- Pregnancy
- Systematic diseases
- Gingival and periodontal involvement.
- Lack of patient cooperation.
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 |
|---|---|---|
| Traditional EscavationPatients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. - Group 6: 15 carious teeth will be excavated chemo-mechanically using Selecti-solve. | Procedure or surgery | Traditional excavation |
| Excavation with Sodium Hypochlorite Gel 2.5%.Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using Sodium Hypochlorite Gel 2.5%. | Procedure or surgery | Sodium Hypochlorite CMCR |
| Excavation with Papacarie DuoPatients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Papacarie Duo. | Procedure or surgery | Papacarie duo CMCR |
| Excavation with Brix3000Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Brix3000. | Procedure or surgery | Selecti-solve CMCR |
| Excavation with Selecti-solvePatients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Selecti-solve. | Procedure or surgery | Brix3000 CMCR |
Primary outcome
Success in caries removal by a detecting dye
Time frame: After procedure completion, which is expected to be within 20 minutes on average.
The efficacy of caries removal will be assessed by a sharp probe aided by Caries Detector dye. The Cavity will be inspected after every application by a sharp probe to feel any tacky sensation in dentin, when it is all hard dentin, caries detector dye will be applied to aid the investigation. Caries detector dye will be left for 10 seconds and then rinsed with water, it will stain the organic matrix of less mineralized dentin so the cavity should be stained homogeneously so high-intensity colored spots refer to infected dentin and it will be removed.
2 secondary outcomes
Time required for caries removal
Time frame: After procedure completion, which is expected to be within 20 minutes on average.
Pain perception during caries removal
Time frame: After procedure completion, which is expected to be within 20 minutes on average.
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 9 Jul 2024.
- Background: PubMed 33931037Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. Comparison of two minimally invasive restorative techniques in improving the oral health-related quality of life of pregnant women: a six months randomized controlled trial. BMC Oral Health. 2021 Apr 30;21(1):221. doi: 10.1186/s12903-021-01581-5.
- Background: PubMed 29161950AlHumaid J, Al-Harbi F, El Tantawi M, Elembaby A. X-ray microtomography assessment of Carisolv and Papacarie effect on dentin mineral density and amount of removed tissue. Acta Odontol Scand. 2018 May;76(4):236-240. doi: 10.1080/00016357.2017.1406614. Epub 2017 Nov 21.
- Background: 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.
- Background: PubMed 34599744de Souza TF, Martins ML, Tavares-Silva CM, Fonseca-Goncalves A, Maia LC. Treatment time, pain experience and acceptability of the technique for caries removal in primary teeth using the ART approach with or without Brix3000 papain gel: a preliminary randomised controlled clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):777-785. doi: 10.1007/s40368-021-00669-4. Epub 2021 Oct 2.
- Background: PubMed 26393204Divya G, Prasad MG, Vasa AA, Vasanthi D, Ramanarayana B, Mynampati P. Evaluation of the Efficacy of Caries Removal Using Polymer Bur, Stainless Steel Bur, Carisolv, Papacarie - An Invitro Comparative Study. J Clin Diagn Res. 2015 Jul;9(7):ZC42-6. doi: 10.7860/JCDR/2015/12705.6202. Epub 2015 Jul 1.
- Background: PubMed 32415190Santos TML, Bresciani E, Matos FS, Camargo SEA, Hidalgo APT, Rivera LML, Bernardino IM, Paranhos LR. Comparison between conventional and chemomechanical approaches for the removal of carious dentin: an in vitro study. Sci Rep. 2020 May 15;10(1):8127. doi: 10.1038/s41598-020-65159-x.
- Background: PubMed 34326596Katiyar A, Gupta S, Gupta K, Sharma K, Tripathi B, Sharma N. Comparative Evaluation of Chemo-mechanical and Rotary-mechanical Methods in Removal of Caries with Respect to Time Consumption and Pain Perception in Pediatrc Dental Patients. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):115-119. doi: 10.5005/jp-journals-10005-1896.
- Background: PubMed 34194848Mancini L, Pisaneschi A, Mancini V, Ginoble M, Quinzi V, Marchetti E, Marzo G. BRIX3000(R) Papain Gel for Cavity Treatment in the Adult Patient. Case Rep Dent. 2021 Jun 12;2021:6624825. doi: 10.1155/2021/6624825. eCollection 2021.
- Background: PubMed 24047844Matsumoto SF, Motta LJ, Alfaya TA, Guedes CC, Fernandes KP, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo: randomized longitudinal clinical trial. Indian J Dent Res. 2013 Jul-Aug;24(4):488-92. doi: 10.4103/0970-9290.118393.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Souad Abboud, DDS MSc PhD study chair
Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus
MHD Baraa Alsayed, DDS principal investigator
MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Escavation, Excavation with Sodium Hypochlorite Gel 2.5%. and Excavation with Papacarie Duo in people with Dental Caries, run by Damascus University at 1 site in Syria.
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 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: finished, as of the sponsor's last update on 9 Jul 2024. 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 Syria. 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?
Success in caries removal by a detecting dye (time frame: After procedure completion, which is expected to be within 20 minutes on average.). 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 NCT05733923, which also lists 9 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 9 Jul 2024.