Post-operative Sensitivity in Resin Composites

Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06242184

Enrollment

Registered

2024-02-05

Start date

2023-05-15

Completion date

2023-11-25

Last updated

2024-02-06

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

Conditions

Caries,Dental, Sensitivity, Tooth

Brief summary

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Detailed description

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Interventions

PROCEDUREGroup A(Nano-fortified Adhesive)

Nano-fortified dentin adhesive

PROCEDUREGroup B(Adhesive without nanoparticles)

Conventional adhesives without nanoparticles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* participants with goof general health status * Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm. * Vital and Periodontally sound teeth

Exclusion criteria

* Patient with Temporomandibular dysfunction * History of spontaneous pain * Endodontically treated teeth * Patient on analgesics within the past two weeks

Design outcomes

Primary

Measure	Time frame	Description
Post-operative sensitivity	One month	Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026