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Active, not recruiting Not applicable

Clinical Success of Stainless Steel Crowns Applied Using Different Cements

NCT06318520 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-08-01
Last updated
2025-01-30

Condition(s) studied

Dental Enamel Hypomineralization

Investigational drug(s) / intervention(s)

Use of Calcium silicate based resin cement and resin modified glass ionomer cement

Use of Calcium silicate based resin cement and resin modified glass ionomer cement: Investigators will restore MIH teeth with stainless steel crowns using calcium silicate-based resin cement and resin-modified glass ionomer cement and evaluate their 1-year success.

Study summary

The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement.

Eligibility

Sex
ALL
Min age
9 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Not having any systemic disease * No history of allergy to any medication or restorative material (local anesthesia, nickel, etc.) * No bad habits (mouth breathing, finger sucking, etc.) * Score 3 or score 4 on the Frankl behavior scale * Children between the ages of 9 and 12 * Agree to come to the controls regularly during the working period Exclusion Criteria: * Score 1 or 2 on the Frankl behavior scale * Molar incisor hypomineralization has not been diagnosed * Indication for unilateral crown * Indication for extraction * Gingival pocket depth exceeding 3 mm * Presence of tooth mobility, abscess, fistula * The opposite tooth of the affected tooth is absent or not in occlusion

Primary outcome measure(s)

  • Anatomical Integrity — 3. month, 6. month, 9. month, 12. month
    0: The crown retains its anatomical integrity. 1. The anatomical integrity of the restoration is impaired but functional. 2. The restoration is fractured, displaced or completely lost.
  • Marginal Compliance — 3. month, 6. month, 9. month, 12. month
    0: Clinically ideal. No opening is observed between crown and gingiva, no sonde enters. 1. Clinically acceptable. There is an opening between the crown and gingiva that does not extend to the prepared tooth. 2. Clinically unacceptable, tooth mobility and an opening extending to the prepared tooth.
  • Proximal Contact — 3. month, 6. month, 9. month, 12. month
    0: Clinically ideal. It is possible to clean the proximal contact area with dental floss. 1. Clinically acceptable. Floss passes hard or loose through the proximal contact area. 2. Clinically unacceptable, proximal contact is not present.
  • Crown Marginal Location — 3. month, 6. month, 9. month, 12. month
    1. Subgingival 2. Gingival level 3.Supragingival
  • Restoration success — 3. month, 6. month, 9. month, 12. month
    1. Crown appearance normal, no cracks, fractures, chips 2. Inconspicuously small loss of material 3. Huge loss of material
  • Green and Vermillion's Oral Hygiene Index — 3. month, 6. month, 9. month, 12. month
    0 No plaque and discoloration 1. Plaque accumulation of less than 1/3 of the tooth surface or extrinsic staining without plaque accumulation and regardless of the surface covered 2. Plaque accumulation more than 1/3 and less than 2/3 of the tooth surface 3. Plaque accumulation covering more than 2/3 of the tooth surface

Trial sites (1)

FacilityCityRegionStatus
Afyonkarahisar Health Sciences University Afyonkarahisar Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06318520 on ClinicalTrials.gov ↗ ← All trials in Turkey