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 range6 Years – 9 Years

SexALL

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).
✕. Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

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

Radiographic evaluation of reparative dentin formation

Timeframe: 6 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 range6 Years – 9 Years

SexALL

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).
✕. Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)

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

Radiographic evaluation of reparative dentin formation

Timeframe: 6 months