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A clinical study Comparing the clinical performance of nanofilled and suprananofilled composite resin material in class 1 cavities of posterior teeth.

Comparative evaluation of the clinical performance of nanofilled and suprananofilled composite resin as direct restorative material in Class I cavities of posterior teeth- A double blind randomized clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046833
Enrollment
35
Registered
2022-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Omnichroma suprananofilled composite (Tokuyama Dental America Inc. Encinitas, CA, U.S): The intervention agents will be placed on the dentinal floor of the tooth after complete caries

Sponsors

MGM Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female adult subjects within the age group of 18-40 years.2. Initial and moderate carious lesions of ICDAS two code 1-4, with atleast 2 teeth in every patient regardless of the location of tooth in the dental arch.3. Human permanent 1st and 2nd maxillary and mandibular premolars and molars with mature apex.4. Only those teeth chosen where proper isolation by rubber dam is possible.5. Teeth to be restored should be in occlusion with its natural antagonist and adjacent teeth.6. Teeth with occlusal class 1 carious lesions.7. Available for follow up visits.8. Low caries index.9. Normal response to electric pulp test and cold test.10. No involvement of pulp viewed on intraoral periapical radiographs.11. Patients with good oral hygiene.

Exclusion criteria

Exclusion criteria: 1. Caries extending sub gingivally. 2. Clinical symptoms of irreversible pulpitis requiring endodontic treatment. 3. Grossly carious teeth. 4. Non-vital teeth with delayed or no response to electric pulp test or thermal stimulation. 5. Participants younger than 18 year of age and older than 40 years of age. 6. Participants with systemic health conditions. 7. Patients with xerostomia, bruxism and traumatic malocclusion. 8. Endodontically treated teeth. 9. Patients with clinical history of allergies to any dental products. 10. Patients who are pregnant and lactating women. 12.Patient undergoing any kind of treatment using analgesics or consuming any anti-inflammatory drugs for a period of one week to 10 days.

Design outcomes

Primary

MeasureTime frame
Evaluation will be performed based on modified USPHS criteria by using probe, explorer, and taking intraoral periapical radiograph after the procedure for anatomic form, marginal adaptation, marginal discolouration, colour match, post operative sensitivity, retention and surface texture.Timepoint: Outcome will be assessed at baseline, after 48 hours, 6 months and 12 months.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Anuradha Patil

MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE

MANASISURWADE14@GMAIL.COM9699374343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026