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

Indirect Pulp Capping Clinical Trial

Official title:

Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236830
• Other study ID #: SDF/potassium iodide
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 1, 2019
• Est. completion date: March 25, 2021

Study information

• Verified date: May 2022
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 25, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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)

Related Conditions & MeSH terms

• Indirect Pulp Capping
• Tertiary Dentine

Intervention

Drug:
• Silver diamine fluoride/ potassium iodide
Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.
• Silver diamine fluoride
Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.
• Resin modified glass ionomer cement
Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. Review. — View 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. — View Citation

Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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