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

Nourhan M.Aly108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Tertiary Dentine Indirect Pulp Capping

Interventions

Silver diamine fluoride/ potassium iodideDRUG

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

Silver diamine fluorideDRUG

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

Resin modified glass ionomer cementDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 9 Years

Medical Language ↔ Plain English

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)

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 6 months

Success of the restoration

Time frame: 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)

Data from ClinicalTrials.gov

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