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Completed

NCT Number: NCT06412731

Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

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. Arrestment of caries lesion and the emergence of a new one 2. Time required for the treatment 3. Adverse events 4. Children's anxiety

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Key information

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Mustansiriyah University

Baghdad, Al-karkh, 10011, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cera-bur

Other

Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material

Other names: Ceramic bur

Brix3000

Other

Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material

Other names: Papain-based CMCR

E-SDF

Other

Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

Other names: 38% Silver Diamine fluoride

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. anxiety level

    Time frame: immediately after the procedure

    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

  2. Time

    Time frame: This will take about from 5 to 30 minutes

    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,

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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