Clinical Success of Stainless Steel Crowns Applied Using Different Cements

NCT06318520 | Active Not Recruiting

• 1 other identifier: AFSU-DHF-TOPAL-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Enamel Hypomineralization

Keywords

Dental Anomaly; Enamel; Stainless Steel Crowns

Outcome Measures

Primary Outcomes (6)

• Anatomical Integrity

  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.

  3. month, 6. month, 9. month, 12. month

• Marginal Compliance

  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.

  3. month, 6. month, 9. month, 12. month

• Proximal Contact

  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.

  3. month, 6. month, 9. month, 12. month

• Crown Marginal Location

  1. Subgingival 2. Gingival level 3.Supragingival

  3. month, 6. month, 9. month, 12. month

• Restoration success

  1. Crown appearance normal, no cracks, fractures, chips 2. Inconspicuously small loss of material 3. Huge loss of material

  3. month, 6. month, 9. month, 12. month

• Green and Vermillion's Oral Hygiene Index

  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

  3. month, 6. month, 9. month, 12. month

Secondary Outcomes (1)

• Marginal Fit of the Crown (RADIOLOGICAL)

  6. month, 12. month

Study Arms (2)

Arm 1

EXPERIMENTAL

Calcium silicate based resin cement

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

Arm 2

EXPERIMENTAL

Resin modified glass ionomer cement

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

Interventions

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

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Burcu GUCYETMEZ TOPAL, Asc. Prof.

  Afyonkarahisar Health Sciences University

  STUDY DIRECTOR

• Esma ATIS, Res. Ass.

  Afyonkarahisar Health Sciences University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asc. Prof.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)