Preventive treatment for hypomineralised molars in children

Evaluation of the preventive efficacy of silver diamine fluoride in comparison to MI varnish in molars affected with molar incisor hypomineralisation in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54243749

Enrollment

100

Registered

2022-01-13

Start date

2021-10-15

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar incisor hypomineralisation Oral Health

Interventions

Silver diamine fluoride (SDF) and MI Varnish will be applied on two permanent molars with MIH, in a split-mouth design. 100 patients will be included in the study. The teeth will be randomized into tw

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients and parents of the patients who accept to participate and sign the informed consent 2. Healthy children aged between 6 and 9 years, with cooperative behavior, presenting at least 2 MIH-affected molars in the same arch 3. Teeth that are fully erupted

Exclusion criteria

Exclusion criteria: 1. Children with ongoing orthodontic treatment 2. Permanent molars affected by dental fluorosis, amelogenesis, or dentinogenesis imperfecta 3. Children with syndromes or developmental disorders 4. MIH-affected molars with clinically visible caries lesions and/or any PEB, restorations, or sealants 5. MIH-affected molars with the occlusal surface totally or partially covered by a gingival operculum 6. Children who are allergic to silver or milk products

Design outcomes

Primary

Measure	Time frame
1. Dental caries evaluated according to International Caries Detection and Assessment System (ICDAS) criteria and given one of the following scores: 0, sound surface; A, initial stage caries (first visual change in enamel); B, moderate stage caries (localized enamel breakdown or underlying dark shadow); or C, extensive-stage caries (visible cavitation in dentin). Scored after 3, 6, 9 and 12 months from baseline 2. Posteruptive Enamel Breakdown (PEB) scored according to the criteria proposed by Ghanim et al. (2017). Each molar will be given one of the following scores: 0, no visible enamel break down; 2, less than one-third of the tooth is affected; 3, at least one third but less than two-thirds of the tooth are affected; and 4, at least two-thirds of the tooth are affected. Scored after 3, 6, 9 and 12 months from baseline	—

Measure

Time frame

1. Dental caries evaluated according to International Caries Detection and Assessment System (ICDAS) criteria and given one of the following scores: 0, sound surface; A, initial stage caries (first visual change in enamel); B, moderate stage caries (localized enamel breakdown or underlying dark shadow); or C, extensive-stage caries (visible cavitation in dentin). Scored after 3, 6, 9 and 12 months from baseline 2. Posteruptive Enamel Breakdown (PEB) scored according to the criteria proposed by Ghanim et al. (2017). Each molar will be given one of the following scores: 0, no visible enamel break down; 2, less than one-third of the tooth is affected; 3, at least one third but less than two-thirds of the tooth are affected; and 4, at least two-thirds of the tooth are affected. Scored after 3, 6, 9 and 12 months from baseline

—

Secondary

Measure	Time frame
Hypomineralised lesion color stability measured using the vita easy shade device at baseline, 6 and 12 months	—

Countries

Syria

Contacts

Public ContactZuhair Al-Nerabieah

zuhairmajid@gmail.com+963 (0)969960118

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026