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NCT Number: NCT04236830

Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars

The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.

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Key information

Conditions

Tertiary Dentine Dental Pulp Diseases Dentin, Secondary Indirect Pulp Capping Stomatognathic Diseases Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For children:

  • Children who are generally healthy.
  • Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
  • Parents signed informed consent.

For first permanent molars:

  • Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007)
  • Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
  • Immature with open apex as revealed by periapical X-ray.

Exclusion criteria

For children:

  • Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
  • Children unable to return for recall visits.

For first permanent molars:

  • Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
  • Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
  • Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

Treatment and study plan

Silver diamine fluoride/ potassium iodide

Drug

Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.

Other names: SDF/KI

Silver diamine fluoride

Drug

Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.

Other names: SDF

resin modified glass ionomer cement

Drug

Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.

Other names: RMGIC

Primary outcomes

  1. Postoperative pain

    Time frame: 6 months

    Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  2. Postoperative pain

    Time frame: 12 months

    Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  3. Tooth Vitality

    Time frame: 6 months

    Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  4. Tooth Vitality

    Time frame: 12 months

    Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)

  5. Success of the restoration

    Time frame: 6 months

    Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)

  6. Success of the restoration

    Time frame: 12 months

    Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)

  7. Radiographic evaluation or root lengthening

    Time frame: 6 months

    Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)

  8. Radiographic evaluation or root lengthening

    Time frame: 12 months

    Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)

  9. Radiographic evaluation of reparative dentin formation

    Time frame: 6 months

    Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)

  10. Radiographic evaluation of reparative dentin formation

    Time frame: 12 months

    Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)

  11. Radiographic evaluation of reparative dentin volume

    Time frame: 12 months

    This was measured using cone beam computed Tomography (CBCT). Reparative dentin radiodensity will be measured in Hounsfield units (HU). (Mathur VP, Dhillon JK, Logani A, Kalra G. 2016)

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
May 19, 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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