Skip to content

Immunological Responses to Different Crown Restorations in Primary Molars: A Randomized Controlled Clinical Trial

Comparative Effects of Stainless Steel, Prefabricated Zirconia, Indirect Composite Resin, and 3D-Printed Crowns on Clinical Parameters and Immunological Biomarkers in Mandibular Second Primary Molars: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260424003
Enrollment
48
Registered
2026-04-24
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Dental Caries

Interventions

Prefabricated stainless steel crowns will be placed on primary mandibular second molars with multiple carious surfaces or loss of proximal contact after standard tooth preparation and cementation proc
Stainless Steel Crown (SSC) Restoration Group in Primary Mandibular Second Molars with Multi-surface Caries or Loss of Proximal Contact,Prefabricated zirconia crowns Restoration Group in Primary Mandi

Sponsors

Ataturk University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1.Age between 5 and 8 years 2.Good general health status ASA I 3.Children eligible for full coverage restoration with multiple carious surfaces or proximal caries in 4.mandibular first primary molars requiring full coverage restoration 5.Presence of a sound contralateral primary molar for each crown type 6.Teeth with non pulp involved limited dentin caries ICDAS 3 to 5 7.No antibiotic use within the last two months 8.Willingness to attend all study visits including baseline 1st day 7th day and 45th day follow up examinations 9.Written informed consent obtained from parents or legal guardians 10.Child willingness to participate and verbal assent appropriate for age

Exclusion criteria

Exclusion criteria: 1.Systemic disease or ASA II and above status 2.Periodontal disease presence 3.Long term antimicrobial therapy use in children 4.Advanced carious lesion in primary second molars ICDAS 6 5.Severe mouth breathing excessive salivation or clinical conditions preventing isolation 6.Lack of cooperation Frankl behavior scale negative or definitely negative behavior 7.Inability to attend regular follow up visits 8.No written informed consent from parents or refusal of child participation

Design outcomes

Primary

MeasureTime frame
Clinical periodontal outcomes of different crown types in primary mandibular second molars Baseline (before crown preparation) Plaque Index PI and Gingival Index GI will be recorded using Silness and Loe criteria. DMFT and CAST indices will be assessed through clinical oral examination using WHO diagnostic criteria

Secondary

MeasureTime frame
Inflammatory and immunological biomarker levels in gingival crevicular fluid after crown placement Baseline, 1 day, 7 days, and 45 days after crown placement Gingival crevicular fluid samples will be collected from study and control teeth at time points and analyzed for RANKL OPG TNF alpha IL 1 beta IL 6 PGE2 and TGF beta using ELISA

Countries

Turkey

Contacts

Public ContactPeris Celikel

Ataturk University

celikelperis@gmail.com5425050919

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026