跳至主要内容
临床试验/CTRI/2025/07/090298
CTRI/2025/07/090298尚未招募2/3 期

COMPARATIVE EVALUATION OF STREPTOCOCCUS MUTANS ADHESION, ORAL HYGIENE STATUS, AND CLINICAL SUCCESS IN PRIMARY MOLARS RESTORED WITH PREFORMED STAINLESS STEEL CROWNS, TITANIUM-NITRIDE COATED STAINLESS STEEL CROWNS, AND VITRIFIED COMPOSITE CROWNS: A RANDOMIZED CONTROLLED TRIAL

Kamesh Bhamare1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月27日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
There is some difference in the Streptococcus mutans adhesion, oral hygiene status, and clinical success of primary molars restored

研究概览

简要总结

TITLE - COMPARATIVE EVALUATION OF STREPTOCOCCUS MUTANS ADHESION, ORAL HYGIENE STATUS, AND CLINICAL SUCCESS IN PRIMARY MOLARS RESTORED WITH PREFORMED STAINLESS STEEL CROWNS, TITANIUM-NITRIDE COATED STAINLESS STEEL CROWNS, AND VITRIFIED COMPOSITE CROWNS: A RANDOMIZED CONTROLLED TRIAL

INTRODUCTION - Stainless steel crowns (SSCs) have been widely used to restore primary teeth that are badly decaying and carious, and teeth requiring pulp therapy procedures or where other restorative materials are ineffective. SSCs are considered one of the best full coverage restorative materials because of easy placement as they are inexpensive, and have the desirable longevity. Braff stated that SSCs were significantly superior to multi-surface amalgams in the restorations of primary molars. Despite its poor aesthetics, it has been extensively used due to its resistance. The development of periodontal disease and secondary caries is thought to be significantly influenced by the adherence and colonization of oral microorganisms on dental surfaces and restoratives. According to research done both in vivo and in vitro, Streptococcus mutans (S. mutans) is one of the bacteria that are isolated from plaque samples from natural to artificial surfaces during the early stages of the development of caries. The first step in a microorganism’s colonization process is the organism’s adherence to a host surface. Accordingly, the assessment of Streptococcus mutans adherence on dental surfaces and restorative materials is crucial to the effective completion of these procedures. Surface-related characteristics, such as roughness, free surface energy, surface tension, wettability, hydrophobicity, hydrophilicity, electrostatic interactions, and microhardness, are among the necessary materials used in dental restorations. These characteristics are clinically significant because they may have an impact on plaque accumulation and staining. Microorganisms will cling more readily to surfaces with higher surface free energy; conversely, a more hydrophobic surface will result in less predicted adherence of microorganisms9. For primary teeth, the prefabricated crowns are available in various sizes and have a well-defined contour. Traditional prefabricated SSCs are widely utilized, and one of the most common issues connected to SSC is gingival tissue inflammation. Bacterial plaque causes gingivitis surrounding restorative materials10. Despite the extensive use of stainless steel crowns in the Pediatric patients, one cannot ignore the fact that they lack antimicrobial properties. Therefore, Titanium nitride coated crowns have been introduced recently. The crown seems bright and golden because of the titanium-nitride coating. The coating might contribute to the surface’s increased hardness. Also, Biradar R. et al (2024) concluded that the microbial adhesion of Streptococcus mutans and plaque accumulation was seen less on the Titanium-coated SSC when compared with conventional SSC, which was statistically significant11. Recently, new preformed aesthetic crowns have been introduced in the market which are manufactured using laser sintering procedure and consist of Vitrified Composite. They have similar flexural modulus as that of natural tooth. They also claim to be highly antibacterial and plaque resistant; however, the comparison of adhesion of microorganisms, especially Streptococcus mutans on Pediatric vitrified composite crowns against Titanium-coated stainless-steel crowns has not been reported before and towards this aim; Also, comparative clinical durability of these crowns has not been evaluated yet. Therefore, we aim to conduct a randomized trial to compare the Streptococcus mutans adhesion, oral hygiene and clinical success of conventional preformed stainless steel crowns with Ti-coated stainless steel crowns and vitrified composite crowns on primary molars.

METHODOLOGY -

Study Design:

Multi-arm, prospective, randomized controlled trial.

Study Setting:

Conducted in the Department of Pediatric and Preventive Dentistry and Microbiology Laboratory after ethical clearance.

Study Population:

Children aged 4–8 years requiring pulpectomy in primary molars.

Sample Size:

60 teeth (20 per group), calculated using OpenEpi software, considering a 15% dropout rate.

Sampling Technique:

Simple random sampling using AI-generated random allocation tables.

Group A: Stainless Steel Crowns

Group B: Vitrified Composite Crowns

Group C: Titanium-Nitride Coated Stainless Steel Crowns

Inclusion Criteria:

Children aged 4–8 years

Primary molars indicated for pulpectomy with sufficient remaining tooth structure

Cooperative patients (Frankl’s positive behavior)

Written parental consent

Exclusion Criteria:

Special needs children

Severely decayed or infra-occluded teeth

Malocclusions, parafunctional habits

Allergies to local anesthetics, chromium, or nickel

Subject Withdrawal:

Voluntary exit, non-compliance, or meeting exclusion criteria later.

Study Materials:

Three types of crowns: stainless steel, titanium-nitride coated, vitrified composite.

Procedure Overview:

Pulpectomy followed by crown placement per standard guidelines for each crown type.

Crown cementation:

SSCs and TiN crowns: Glass ionomer cement

Vitrified composite crowns: Composite cement with etching and bonding

Outcome Measures:

Streptococcus mutans adhesion: Evaluated at baseline, 3, 6, and 12 months via plaque sampling, cultured on MSB agar.

Oral Hygiene Status: Plaque and Gingival Index recorded at each follow-up.

Clinical Success: Assessed using Modified USPHS criteria for retention, occlusion, crown integrity, occlusal wear, marginal adaptation, anatomical form, and secondary caries.

Follow-up Period:

Baseline, 3 months, 6 months, and 12 months.

Data Recording:

Systematic documentation at each follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children with one or more primary molars indicated for pulpectomy.
  • Teeth with at least 50% of tooth structure intact, functioning in occlusion with an opposing tooth.
  • Frankl’s positive and definitely positive patients.
  • Parents/ guardians willing to provide written consent.

排除标准

  • Children with special needs.
  • Severely decayed Primary molars prohibiting the retention and sealing of the restoration.
  • Inadequate root length.
  • The child allergic to local anesthesia, chromium, or nickel.
  • Primary molar in infra-occlusion.
  • Presence of malocclusions such as crossbite or scissor bite.
  • Child with parafunctional habits.

结局指标

主要结局

There is some difference in the Streptococcus mutans adhesion, oral hygiene status, and clinical success of primary molars restored

时间窗: 2 years, 2 months

with preformed stainless steel crowns, titanium-nitride coated stainless steel crowns, and vitrified composite crowns.

时间窗: 2 years, 2 months

次要结局

  • There is no significant difference in the Streptococcus mutans(adhesion, oral hygiene status, and clinical success of primary molars restored with preformed stainless steel crowns, titanium nitride coated stainless steel crowns, and vitrified composite crowns.)

研究者

发起方
Kamesh Bhamare
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR YOGESH KALE

Maharashtra Institute of Dental Sciences and Research, Latur, Maharashtra

研究点 (1)

Loading locations...

相似试验