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

Primary Purpose

Carious Lesion

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Composite resin restoration using Titania nanoparticle reinforced bonding agent
Composite resin restoration without Titania nanoparticle incorporated bonding agent
Sponsored by
Pakistan Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Lesion focused on measuring Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry, Pakistan Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent

Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent

Outcomes

Primary Outcome Measures

Post-restorative sensitivity in composite resin restoration
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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
September 9, 2023
Sponsor
Pakistan Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05744648
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Lesion
Keywords
Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked.
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent
Intervention Type
Procedure
Intervention Name(s)
Composite resin restoration using Titania nanoparticle reinforced bonding agent
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Composite resin restoration without Titania nanoparticle incorporated bonding agent
Intervention Description
Composite resin restoration without Titania nanoparticle incorporated bonding agent
Primary Outcome Measure Information:
Title
Post-restorative sensitivity in composite resin restoration
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehal Amir, BDS
Organizational Affiliation
Pakistan Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Pakistan Institute of Medical Sciences
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31592280
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.
Results Reference
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PubMed Identifier
23138046
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.
Results Reference
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Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity

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