Clincosm LogoSign in Get a demo

Post Restorative Sensitivity in Adhesive Resin Restoration Using Titania Nanoparticles Reinforced Bonding Agent

Sponsor
Pakistan Institute of Medical Sciences (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05744648
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6.1
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adhesive resin restoration using Titania nanoparticle reinforced bonding agent
  • Procedure: Adhesive resin restoration without Titania nanoparticle incorporated bonding agen
 N/A

Detailed Description

In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in adhesive resin 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 rubberdam 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 day 1, after 1 week and after 1 month. Sensitivity will be assessed using Visual analog scale (VAS)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked.
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Novel Titania Nanoparticle-reinforced Bonding Agent on Post-restorative Sensitivity in Adhesive Resin Restoration
Actual Study Start Date :
Dec 26, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Group A will recieve Adhesive resin restoration with Titania nanoparticle incorporated bonding agent

Procedure: Adhesive resin restoration using Titania nanoparticle reinforced bonding agent
Each group will receive Adhesive resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used
Experimental: Group B

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

Procedure: Adhesive resin restoration without Titania nanoparticle incorporated bonding agen
Adhesive resin restoration without Titania nanoparticle incorporated bonding agen

Outcome Measures

Primary Outcome Measures

  1. Post-restorative sensitivity in adhesive resin restoration [1 month]

    Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Participants with good general health

  • Selected teeth should be vital and periodontically healthy

  • Class-I and Class-II carious lesion with minimum depth of 2mm

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Dentistry, Pakistan Institute of Medical Sciences Islamabad Pakistan

Sponsors and Collaborators

  • Pakistan Institute of Medical Sciences

Investigators

  • Principal Investigator: Nehal Amir, BDS, Pakistan Institute of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
NEHAL AMIR, NAMIR, Pakistan Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05744648
Other Study ID Numbers:
  • NAMIR
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries
Titanium dioxide

Study Results

No Results Posted as of Feb 27, 2023