Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity

Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05744648

Enrollment

Registered

2023-02-27

Start date

2023-01-05

Completion date

2023-06-20

Last updated

2023-09-13

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

Conditions

Carious Lesion

Keywords

Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania

Brief summary

Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations. Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.

Detailed description

In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.

Interventions

PROCEDUREComposite resin restoration using Titania nanoparticle reinforced bonding agent

Each group will receive Composite resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used

PROCEDUREComposite resin restoration without Titania nanoparticle incorporated bonding agent

Composite resin restoration without Titania nanoparticle incorporated bonding agent

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked.

Intervention model description

In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Participants with good general health * Selected teeth should be vital and periodontally healthy * Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm * Defective previous restorations in need of replacement (secondary caries/fractures) * Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth

Exclusion criteria

* Patients with Temporomandibular disorders * Extremely poor oral hygiene status * Teeth with very deep carious lesions * Teeth with periapical or periodontal pathology * Patients taking anti-inflammatory, analgesics or psychotropic drugs * History of spontaneous pain * Previously root canal treated teeth

Design outcomes

Primary

Measure	Time frame	Description
Post-restorative sensitivity in composite resin restoration	1 month	Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 means worst outcomes

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026