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

Nourhan M.Aly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Indirect Pulp Capping; Tertiary Dentine

Treatments: Drug: Resin modified glass ionomer cement; Drug: Silver diamine fluoride; Drug: Silver diamine fluoride/ potassium iodide

Study type: Interventional

Funder types: Other

Identifiers

NCT04236830

SDF/potassium iodide

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

108 participants in 3 patient groups

Silver diamine fluoride/ potassium iodide group

Experimental group

Description:

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

Treatment:

Drug: Silver diamine fluoride/ potassium iodide

Silver diamine fluoride group

Experimental group

Description:

Advantage arrest TM, Elevate Oral Care, USA

Treatment:

Drug: Silver diamine fluoride

Resin modified glass ionomer cement group

Active Comparator group

Description:

Riva light cure, SDI, Bayswater, Australia

Treatment:

Drug: Resin modified glass ionomer cement