CompletedPhase 2/3

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

Egypt108 participantsStarted 2019-11-01

Plain-language 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.

Who can participate

Age range

6 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. Immature with open apex as revealed by periapical X-ray.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain

Timeframe: 6 months

Postoperative pain

Timeframe: 12 months

Tooth Vitality

Timeframe: 6 months

Tooth Vitality

Timeframe: 12 months

Success of the restoration

Timeframe: 6 months

Success of the restoration

Timeframe: 12 months

Radiographic evaluation or root lengthening

Timeframe: 6 months

Radiographic evaluation or root lengthening

Timeframe: 12 months

Trial details

NCT IDNCT04236830

SponsorNourhan M.Aly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Tertiary Dentine trials

Who can participate

Age range

6 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. Immature with open apex as revealed by periapical X-ray.

Exclusion criteria

. 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).

What they're measuring

Postoperative pain

Timeframe: 6 months

Postoperative pain

Timeframe: 12 months

Tooth Vitality

Timeframe: 6 months

Tooth Vitality

Timeframe: 12 months

Success of the restoration

Timeframe: 6 months

Success of the restoration

Timeframe: 12 months

Radiographic evaluation or root lengthening

Timeframe: 6 months

Radiographic evaluation or root lengthening

Timeframe: 12 months