Clinical trial NCT05744648: Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity
Official title: Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carious Lesion
Keywords: Composite resins
Dentin bonding agents
Dentin Sensitivity
Nanoparticles
Titania
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-restorative sensitivity in composite resin restoration
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Pakistan Institute of Medical Sciences
Study officials:
affiliation: Pakistan Institute of Medical Sciences
name: Nehal Amir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.
citation: Melo MA, Cheng L, Zhang K, Weir MD, Rodrigues LK, Xu HH. Novel dental adhesives containing nanoparticles of silver and amorphous calcium phosphate. Dent Mater. 2013 Feb;29(2):199-210. doi: 10.1016/j.dental.2012.10.005. Epub 2012 Nov 6.