Actively Recruiting

Phase Not Applicable
Age: 6Years - 9Years
All Genders
Healthy Volunteers
NCT06801561

EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)

Led by Alexandria University · Updated on 2025-01-30

134

Participants Needed

1

Research Sites

117 weeks

Total Duration

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AI-Summary

What this Trial Is About

Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrical involvement of one to four permanent first molars (PFM) with or without incisor teeth involvement. MIH molars are prone to post-eruptive breakdown (PEB) and to the development of atypical caries lesions. Aim of the study: To evaluate and compare the preventive effect of glass ionomer sealant and laser therapy (LT) against dental caries and PEB on molars affected by molar incisor hypomineralisation (MIH) Materials and Method: This study is a two-arm, parallel group, randomized clinical trial. A sample of children (n=134) with an age range of 6-9 years old, having a first permanent molar erupted with MIH without PEB or 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 134 first permanent molars will be randomly and equally allocated into two groups. Group 1(n=67): LT and Group 2 (n=67): Glass ionomer sealant (Fuji triage). Dental caries, PEB, retention of sealant and child-self-reported discomfort will be clinically evaluated after 6, 12 and 18months. Associations between dental caries and PEB with independent variables will be evaluated using logistic regression analysis (p \< 0.05).

CONDITIONS

Official Title

EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)

Who Can Participate

Age: 6Years - 9Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 9 years
  • One first permanent molar with molar incisor hypomineralisation (MIH) without post-eruptive breakdown
  • MIH tooth with ICDAS scores 0, 1, or 2 (no or minimal decay)
  • Good overall health (ASA I classification)
Not Eligible

You will not qualify if you...

  • First permanent molars with active cavities (ICDAS scores 5 or 6) or defective restorations
  • Teeth with enough dentin loss to require restorative treatment
  • Presence of clinical signs of dental infection such as abscess or fistula

AI-Screening

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Trial Site Locations

Total: 1 location

1

Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

M

Marwa Baraka

CONTACT

R

Rodaina H Helmy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL) | DecenTrialz