A clinical trial to compare the efficacy of various esthetic crowns in primary posterior teeth requiring full coverage restorations.

Phase 3

Not yet recruiting

• Conditions: Patients requiring full coverage restorations on primary posterior teeth.

• Registration Number: CTRI/2024/07/071685
• Lead Sponsor: Dr Ankita Mishra

Brief Summary

In young children, caries more often involves the primary molars, and the early loss of these teeth has detrimental effects such as potentially compromising the dentition’s integrity, impaired nutrition due to pain, negative effects on growth and development, and producing an undesirable esthetic appearance. The fundamental objective of restorative therapy in primary dentition is to retain them until exfoliation, which is justified from the biological, functional, psychological, and esthetic point of view.

When a tooth undergoes endodontic intervention, it is advisable to place a dental crown subsequently as it maintains the form and function of the tooth, prevents microleakage and re-infection, maintains esthetics, and provides strength to the tooth. Hence, dental crowns have become a salient factor in the restoration of the extensively carious lesion. The preformed metal crowns, also known as stainless steel crowns have been the benchmark restoration for primary molars after pulpal treatment. However, their advantages are insufficient to compensate for their unappealing appearance, and their metallic aspect remains a problem. On that account, to overcome the esthetic concern Zirconia crowns were introduced in pediatric dentistry, to provide white full coronal restorations for primary teeth.Zirconia crowns are anatomically contoured, metal-free, bio-inert, white-colored, and resistant to dental decay.The most important advantage of the zirconia crown is its “gingival friendly†property compared to other crowns. However, these crowns have some drawbacks, including the need for extensive tooth preparation to achieve a passive fit, a higher price tag than most other crowns, and the inability to be adjusted, crimped, or shaped. To address these drawbacks, different pediatric crowns made up of densely filled composite with laser-sintered barium glass have been added to the array of pediatric esthetic full-coverage restorations in 2018.These crowns permit minimally invasive, quick, and safe treatment with maximum aesthetic results. They have an outline that resembles the primary tooth’s anatomy and features antibacterial and plaque-resistance properties. Additionally, these crowns are said to be biocompatible, and bio-functional, and exhibit natural abrasion behavior which prevents them from damaging their antagonists. However, these crowns are expensive and they are yet to be clinically experimented.

The most recent introduction in the preformed esthetic crowns is the Bioflx crown - made up of high-impact hybrid resin polymer, they are metal and Bis-GMA free. The manufacturers claim that the Bioflx Crowns are the world’s first flexible, durable, self-adaptable with snug/active fit, and an ideal full coverage restoration that offer properties of both stainless steel crowns and zirconia crowns.

There is limited research available that directly compares the clinical outcomes of various aesthetic crowns. Therefore, this study is done to comparatively evaluate three esthetic crowns in primary molars in terms of their retention, marginal integrity, discoloration, secondary caries, gingival health, and patient satisfaction.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-07-30
• Study Start: 2024-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Primary molars with adequate crown structure, requiring full coverage restorations.
• Parents/patient’s esthetic requirements.

Exclusion Criteria

Less than 1/3rd crown structure left, teeth indicated for extraction, uncooperative children.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention, marginal integrity, discoloration and patient satisfaction of full coverage restorations. Effect on gingival health and the ability of crowns to prevent secondary caries.	12 months

Secondary Outcome Measures

Name	Time	Method
Effect on gingival health and the ability of crowns to prevent secondary caries.	12 months

Trial Locations

Locations (1)

Subharti Dental College and Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Subharti Dental College and Hospital

🇮🇳Meerut, UTTAR PRADESH, India

Dr Ankita Mishra

Principal investigator

09934795930

ankitamishra1012@gmail.com