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Clinical Trials/CTRI/2024/12/077528
CTRI/2024/12/077528
Not yet recruiting
Not Applicable

Comparative evaluation of clinical and radiographic success of titanium nitride coated stainless steel crowns and stainless steel crowns in primary molars: A Randomized Controlled Study

Dr Ramya T R1 site in 1 country58 target enrollmentStarted: December 20, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Ramya T R
Enrollment
58
Locations
1
Primary Endpoint
Percentage of clinical and radiographic success of Titanium nitride coated stainless

Overview

Brief Summary

Dental caries is one of the widespread medical conditions in adults and children. According to WHO Oral Health facts, more than 530 million children suffer from dental caries of primary teeth. The management of multi-surface carious primary molar is challenging to clinician, there are variety of materials such as amalgam, composites, and stainless steel crowns (SSC’s) used to reconstruct the carious teeth. SSC’s are widely used and are very popular in pediatric dentistry due to its superiority and durability compared to multi surface amalgam restorations. However, the disadvantage is poor esthetics and perforation rate of approximately 2%. Titanium nitride coated stainless steel crowns (TiNC’s) is newly introduced, which have golden colour and its hardness have been proposed to be better than that of conventional SSC’s. It is also esthetically more appreciated by parents. Titanium is widely used in Medical and Dentistry, with high success rates, due to its high corrosion resistance, low toxicity, very low allergic potential and biocompatibility. The introduction of TiNCs has broadened the range of options for posterior teeth restoration.1 Titanium nitride coating makes the crown appear yellow/golden color, it tends to attract children’s attention and seemed to be more likeable. However no long-term studies are available regarding TiNCs. It is important to assess gingival health, oral hygiene status of the teeth restored with SSC’s and TiNC’s. Keeping in mind the paucity of literature, this study is designed to explore the clinical and radiographic success, gingival health and plaque accumulation of TiNC’s against SSC’s in primary molars.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Healthy Co-operative child patients aged 6-9 years with primary mandibular molars treated with pulp therapy (Pulpotomy and Pulpectomy) or with multi-surface carious lesions.

Exclusion Criteria

  • Tooth with internal resorption, tooth with more than 2/3 root resorption, Patients with very poor oral hygiene and DMFT score more than 5, Patients with known allergy to nickel and titanium, Patients with bruxism habit.

Outcomes

Primary Outcomes

Percentage of clinical and radiographic success of Titanium nitride coated stainless

Time Frame: 1 3 6 and 12 months

Steel crowns and stainless steel crowns at the end of on year

Time Frame: 1 3 6 and 12 months

Secondary Outcomes

  • Percentage of success of gingival health and plaque accumulation of Titanium(Nitride coated stainless steel crowns and stainless steel crowns at the end of one year.)

Investigators

Sponsor
Dr Ramya T R
Sponsor Class
Other [nil]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ramya T R

Government Dental College and Research Institute, Bangalore

Study Sites (1)

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