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

NCT04236830 | Completed Phase 2

• 1 other identifier: SDF/potassium iodide
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tertiary Dentine; Indirect Pulp Capping

Keywords

Silver diamine fluoride/ potassium iodide; glass ionomer cement

Outcome Measures

Primary Outcomes (11)

• Postoperative pain

  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)

  6 months

• Postoperative pain

  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)

  12 months

• Tooth Vitality

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

  6 months

• Tooth Vitality

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

  12 months

• Success of the restoration

  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 months

• Success of the restoration

  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)

  12 months

• Radiographic evaluation or root lengthening

  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)

  6 months

• Radiographic evaluation or root lengthening

  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)

  12 months

• Radiographic evaluation of reparative dentin formation

  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)

  6 months

• Radiographic evaluation of reparative dentin formation

  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)

  12 months

• Radiographic evaluation of reparative dentin volume

  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)

  12 months

Study Arms (3)

Silver diamine fluoride/ potassium iodide group

EXPERIMENTAL

Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia

Drug: Silver diamine fluoride/ potassium iodide

Silver diamine fluoride group

EXPERIMENTAL

Advantage arrest TM, Elevate Oral Care, USA

Drug: Silver diamine fluoride

Resin modified glass ionomer cement group

ACTIVE COMPARATOR

Riva light cure, SDI, Bayswater, Australia

Drug: Resin modified glass ionomer cement

Interventions

Silver diamine fluoride/ potassium iodide DRUG

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

Also known as: SDF/KI

Silver diamine fluoride/ potassium iodide group

Silver diamine fluoride DRUG

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

Also known as: SDF

Silver diamine fluoride group

Resin modified glass ionomer cement DRUG

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

Also known as: RMGIC

Resin modified glass ionomer cement group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (6)

• Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.

  PMID: 17555173 BACKGROUND

• Dikmen B. Icdas II criteria (international caries detection and assessment system). J Istanb Univ Fac Dent. 2015 Oct 21;49(3):63-72. doi: 10.17096/jiufd.38691. eCollection 2015.

  PMID: 28955548 BACKGROUND

• Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, Fontana M, Graham L. Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2017 Sep 15;39(5):135-145.

  PMID: 29070149 BACKGROUND

• Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.

  PMID: 27931467 BACKGROUND

• Baraka MMAL, Cevidanes L, Tekeya M, Bakry N, Ruellas A, Botero T, Benavides E, Fontana M. Three-Dimensional Assessment of Radiographic Changes after Indirect Pulp Capping Using Silver Diamine Fluoride with or without Potassium Iodide in Young Permanent Teeth (12-Month RCT). Caries Res. 2023;57(2):177-188. doi: 10.1159/000529893. Epub 2023 Mar 6.

  PMID: 36878216 DERIVED

• Baraka M, Tekeya M, Bakry NS, Fontana M. Twelve-month randomized controlled trial of 38% silver diamine fluoride with or without potassium iodide in indirect pulp capping of young permanent molars. J Am Dent Assoc. 2022 Dec;153(12):1121-1133.e1. doi: 10.1016/j.adaj.2022.08.008. Epub 2022 Oct 15.

  PMID: 36253166 DERIVED

MeSH Terms

Conditions

Dentin, Secondary

Interventions

silver diamine fluoride; Potassium Iodide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Study Officials

• Marwa Baraka, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Magda El-Tekeya, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Niveen Bakry, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Fontana Margherita

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dental Public Health clinical instructor and study statistician

Model Details: This is a 3 arm clinical trial. All selected first permanent molars will be randomly equally allocated into three groups according to capping material used.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: November 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 25, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

EG (1)