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

Phase 2

Completed

• Conditions: Tertiary Dentine; Indirect Pulp Capping
• Interventions: Drug: Silver diamine fluoride; Drug: Silver diamine fluoride/ potassium iodide; Drug: Resin modified glass ionomer cement

• Registration Number: NCT04236830
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver diamine fluoride group	Silver diamine fluoride	Advantage arrest TM, Elevate Oral Care, USA
Silver diamine fluoride/ potassium iodide group	Silver diamine fluoride/ potassium iodide	Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia
Resin modified glass ionomer cement group	Resin modified glass ionomer cement	Riva light cure, SDI, Bayswater, Australia

Primary Outcome Measures

Name	Time	Method
Radiographic evaluation of reparative dentin formation	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)
Success of the restoration	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)
Postoperative pain	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)
Tooth Vitality	12 months	Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)
Radiographic evaluation or root lengthening	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)
Radiographic evaluation of reparative dentin volume	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)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt