Clinical trial NCT04236830: Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars
Official title: Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tertiary Dentine
Indirect Pulp Capping
Keywords: Silver diamine fluoride/ potassium iodide
glass ionomer cement
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-01-22
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

For children:

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

For first permanent molars:

1. 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)
2. 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)
3. Immature with open apex as revealed by periapical X-ray.

Exclusion Criteria:

For children:

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

For first permanent molars:

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

Primary outcomes:
measure: Postoperative pain
timeFrame: 6 months
measure: Postoperative pain
timeFrame: 12 months
measure: Tooth Vitality
timeFrame: 6 months
measure: Tooth Vitality
timeFrame: 12 months
measure: Success of the restoration
timeFrame: 6 months
measure: Success of the restoration
timeFrame: 12 months
measure: Radiographic evaluation or root lengthening
timeFrame: 6 months
measure: Radiographic evaluation or root lengthening
timeFrame: 12 months
measure: Radiographic evaluation of reparative dentin formation
timeFrame: 6 months
measure: Radiographic evaluation of reparative dentin formation
timeFrame: 12 months
measure: Radiographic evaluation of reparative dentin volume
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Marwa Baraka, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Magda El-Tekeya, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Niveen Bakry, PhD
role: STUDY_CHAIR
affiliation: University of Michigan
name: Fontana Margherita
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.
citation: 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.