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Chemomechanical caries removal in primary teeth

Performance Evaluation of Enzyme Pepsin-based Gel in Chemomechanical caries removal (CMCR) for primary Anterior teeth

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001759886
Enrollment
46
Registered
2021-12-23
Start date
2019-11-11
Completion date
2020-12-15
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the clinical and radiographic effectiveness of Enzyme Pepsin-based Gel compared with carisolv solution as chemomechanical caries removal agents in Primary teeth. Randomized controlled clinical trial The null hypothesis tested is that there is no statistically significant difference in clinical and radiographic success rates between Enzyme Pepsin-based Gel and carisolv solution.

Interventions

Anterior primary teeth with class V caries in children aged 4-7 years, who screen in the Department of Pediatric Dentistry at Damascus university, will be involved in this split mouth design study Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed. The carious lesion will be covered with Enzyme Pepsin-based Gel and left undisturbed for 40 s. Then, it will be removed by scraping gently with a spoon excav

Anterior primary teeth with class V caries in children aged 4-7 years, who screen in the Department of Pediatric Dentistry at Damascus university, will be involved in this split mouth design study Intra- and extraoral examinations of patients will be performed before the treatment and their initial radiologic examinations will be performed. The carious lesion will be covered with Enzyme Pepsin-based Gel and left undisturbed for 40 s. Then, it will be removed by scraping gently with a spoon excavator without application of any vertical pressure, under the isolation of rubber dam, this process will be repeated until the cavity appeare clean. caries detector dye will be used to confirm that the cavity is free of caries. All teeth will be restored with Glass inomer cement. The expected duration for the whole procedure is 20 minutes A single practitioner will perform excavation of caries for all teeth so that caries removal and excavation will be identical. Clinical and radiographic evaluation will be performed after 3 and 6 Months.

Sponsors

Damascus University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
4 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria of participants: 1. Healthy and Cooperative patients approving the trial. Inclusion Criteria of teeth: 1. Teeth with symmetric, open access ,buccal dentinal carious lesions in need of cosmetic restorations (the dental digital value by DIAGNOdent is 28-35) 2. vital teeth with no clinical or radiographic signs of pulpal involvement 3. have no defects in tooth formation or tooth development

Exclusion criteria

1. unhealthy or non-Cooperative patients. 2. Clinical or radiographic Signs and symptoms that indicate an infected pulp 3. extensive depth of caries extend the pulpal third of dentine

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026