Tertiary DentinePhase 2/3NCT04236830
Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars
A Phase 2/3 study testing Silver diamine fluoride/ potassium iodide, Silver diamine fluoride and Resin modified glass ionomer cement in people with Tertiary Dentine and Indirect Pulp Capping, run by Nourhan M.Aly at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Tertiary Dentine, Indirect Pulp Capping
- What is being tested?
- Silver diamine fluoride/ potassium iodide, Silver diamine fluoride and Resin modified glass ionomer cement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 25 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For children:
- Children who are generally healthy.
- Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
- Parents signed informed consent.
- For first permanent molars:
- 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)
- 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)
- Immature with open apex as revealed by periapical X-ray.
Who cannot join
- For children:
- Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
- Children unable to return for recall visits.
- For first permanent molars:
- Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
- Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
- Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)
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.
Read the 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.
- Conditions
- Tertiary Dentine, Indirect Pulp Capping
- Being tested
- Silver diamine fluoride/ potassium iodide, Silver diamine fluoride, Resin modified glass ionomer cement
- Keywords
- Silver diamine fluoride/ potassium iodide, glass ionomer cement
- Medical subject headings
- Dentin, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluoride/ potassium iodideDrug
Also called SDF/KI
Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.
Silver diamine fluorideDrug
Also called SDF
Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.
Resin modified glass ionomer cementDrug
Also called RMGIC
Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.
| Study group | Role | What they receive |
|---|---|---|
| Silver diamine fluoride/ potassium iodide group | Experimental | Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia Receives: Drug: Silver diamine fluoride/ potassium iodide |
| Silver diamine fluoride group | Experimental | Advantage arrest TM, Elevate Oral Care, USA Receives: Drug: Silver diamine fluoride |
| Resin modified glass ionomer cement group | Active comparator | Riva light cure, SDI, Bayswater, Australia Receives: Drug: Resin modified glass ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 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)
Measured: 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)
Measured: 6 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)
Measured: 12 months
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)
Measured: 6 months
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tertiary DentineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Marwa Baraka, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMagda El-Tekeya, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptNiveen Bakry, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptFontana Margherita, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236830
- Sponsor's protocol ID
- SDF/potassium iodide
- Status last verified
- May 2022
- First submitted
- 17 Jan 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17555173Dikmen 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.
PubMed 28955548Crystal 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.
PubMed 29070149Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.
PubMed 27931467Baraka MMAL, Cevidanes L, Tekeya M, Bakry N, Ruellas A, Botero T, Benavides E, Fontana M. Three-Dimensional Assessment of Radiographic Changes after Indirect Pulp Capping Using Silver Diamine Fluoride with or without Potassium Iodide in Young Permanent Teeth (12-Month RCT). Caries Res. 2023;57(2):177-188. doi: 10.1159/000529893. Epub 2023 Mar 6.
PubMed 36878216Baraka 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.
PubMed 36253166
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04236830
- Acronym / sponsor ID
- SDF/potassium iodide
- Conditions
- Tertiary Dentine, Indirect Pulp Capping
- Keywords
- Silver diamine fluoride/ potassium iodide, glass ionomer cement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silver diamine fluoride/ potassium iodide group | Experimental | Drug: Silver diamine fluoride/ potassium iodideRiva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia |
| Silver diamine fluoride group | Experimental | Drug: Silver diamine fluorideAdvantage arrest TM, Elevate Oral Care, USA |
| Resin modified glass ionomer cement group | Active comparator | Drug: Resin modified glass ionomer cementRiva light cure, SDI, Bayswater, Australia |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children who are generally healthy.
- Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
- Parents signed informed consent.
- 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)
- 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)
Key exclusion criteria (7 listed)
- Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
- Children unable to return for recall visits.
- Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
- Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
- Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver diamine fluoride/ potassium iodideAlso: SDF/KIThirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material. | Drug | Silver diamine fluoride/ potassium iodide group |
| Silver diamine fluorideAlso: SDFThirty six first permanent molars will receive 38% SDF as an indirect pulp capping material. | Drug | Silver diamine fluoride group |
| Resin modified glass ionomer cementAlso: RMGICThirty six first permanent molars will receive RMGIC as an indirect pulp capping material. | Drug | Resin modified glass ionomer cement group |
Primary outcome
Postoperative pain
Time frame: 6 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)
Postoperative pain
Time frame: 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
Time frame: 6 months
Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)
Tooth Vitality
Time frame: 12 months
Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)
Success of the restoration
Time frame: 6 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)
Success of the restoration
Time frame: 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)
Radiographic evaluation or root lengthening
Time frame: 6 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 or root lengthening
Time frame: 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 formation
Time frame: 6 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)
Radiographic evaluation of reparative dentin formation
Time frame: 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)
Radiographic evaluation of reparative dentin volume
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 17555173Ekstrand 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.
- Background: PubMed 28955548Dikmen 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.
- Background: PubMed 29070149Crystal 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.
- Background: PubMed 27931467Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available.
- Derived from this study: PubMed 36878216Baraka MMAL, Cevidanes L, Tekeya M, Bakry N, Ruellas A, Botero T, Benavides E, Fontana M. Three-Dimensional Assessment of Radiographic Changes after Indirect Pulp Capping Using Silver Diamine Fluoride with or without Potassium Iodide in Young Permanent Teeth (12-Month RCT). Caries Res. 2023;57(2):177-188. doi: 10.1159/000529893. Epub 2023 Mar 6.
- Derived from this study: PubMed 36253166Baraka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Baraka, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Magda El-Tekeya, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Niveen Bakry, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Silver diamine fluoride/ potassium iodide, Silver diamine fluoride and Resin modified glass ionomer cement in people with Tertiary Dentine and Indirect Pulp Capping, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236830, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.