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OpenTrials
Completed

NCT Number: NCT04005872

Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment

The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.

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Key information

Conditions

Deep Caries

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba Mohamed Refaat Fouad Genena

Cairo, Egypt

About this study

This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients:

  • Cooperative children.
  • Both genders.
  • In age range from 4 to 7 years.

Teeth:

  • Vital second primary molars with deep caries limited to occlusal surface.
  • No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
  • No radiographic abnormalities
  • Restorable teeth.

Exclusion criteria

  • • Children with known history of allergy to any of the tested materials.
  • Children with systemic conditions.
  • Parents who refused to participate.

Treatment and study plan

Nano Silver Fluoride

Drug

Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.

Other names: NSF

Calcium hydroxide

Drug

Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.

Other names: CaoH

Primary outcomes

  1. Spontaneous pain or pain on biting

    Time frame: 12 months

    By asking patient

  2. Pain on percussion

    Time frame: 12 months

    By the back of mirror

  3. Swelling

    Time frame: 12 months

    Clinical examination by operator

  4. Mobility

    Time frame: 12 months

    Clinical examination by operator

  5. Sinus or fistula tract

    Time frame: 12 months

    Clinical examination by operator

Secondary outcomes

  1. Furcation or perapical radiolucency

    Time frame: 12 months

    Periapical radiograph

  2. External or internal root resorption

    Time frame: 12 months

    Periapical radiograph

  3. Widening periodontal membrane space

    Time frame: 12 months

    Periapical radiograph

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial

Acronym: RCT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2019
Registry last updated
Dec 20, 2022

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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