BIS prepares new rules for materials used in root canal treatment

With more than 1.5 crore root canal treatments performed annually in India, the Bureau of Indian Standards (BIS) has proposed revised specifications for materials used in this procedure. According to a report by Mint, BIS has issued draft standards for both root canal filling materials and sealers used to seal canals.

The primary objective of these new rules is to standardise the size of materials, improve their X-ray visibility, and introduce a common colour-coding and labelling system. This will make it easier for dentists to select the appropriate product for the procedure. These revised standards aim to reduce variations among manufacturers and improve the clinical decision-making process.

Under the new rules, materials must be clearly visible on X-rays so that dentists can verify if they have been placed correctly. Standardised numerical and colour coding will also make it easier to differentiate between various product sizes. This step has been taken in view of increasing evidence of disparities in products available in the market. A 2025 study showed significant differences in the properties of four root canal sealers, such as flow, X-ray visibility, and solubility, with some products failing to meet international ISO standards.

According to two government officials, these proposals are in two draft Indian Standards: one for materials to fill root canals and another for sealing materials used in root canal procedures and other dental treatments. One official stated that the revised standards aim to assist dentists in selecting filling materials according to the requirements of different root canals. By determining radiopacity, materials will appear in X-ray images, helping dentists assess their position.

These draft proposals also specify requirements for product marking, labelling, packaging, and instructions for use, to ensure that manufacturers provide consistent information about their products. The standards on sealing materials will apply to other treatments such as apexification, perforation filling, resorption treatment, and retrograd root-end filling, in addition to traditional root canal procedures.

Dr Pawan Kumar, dentist and Director of Delhi-based Dentmark Dental Clinic, stated that root canal treatment requires precision, as the materials used to fill and seal the root canal play a crucial role in the procedure. He added that standardising their dimensions, radiopacity, and identification system could help dentists select the right materials and assess their position via dental X-rays. Kumar further noted that clear specifications and better instructions from manufacturers could alleviate the confusion dentists face while working with various materials. He termed this a useful step towards consistent practice, though he added that the final outcome depends on the dentist's skill and the overall treatment.

The market for root canal filling and sealing materials in India was $24.48 million in 2025. The spokesperson for the Ministry of Consumer Affairs was approached for comment on this matter but received no response.

The Bureau of Indian Standards (BIS) is an institution of the Government of India that works to set national standards for the quality, specification, and reliability of products and services in the country.