NCT05744648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

February 16, 2023

Last Update Submit

September 9, 2023

Conditions

Carious Lesion

Keywords

Composite resinsDentin bonding agentsDentin SensitivityNanoparticlesTitania

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (2)

Group A

EXPERIMENTAL

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

Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent

Group B

EXPERIMENTAL

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

Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent

Interventions

Composite resin restoration using Titania nanoparticle reinforced bonding agentPROCEDURE

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

Group A
Composite resin restoration without Titania nanoparticle incorporated bonding agentPROCEDURE

Composite resin restoration without Titania nanoparticle incorporated bonding agent

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Pakistan Institute of Medical Sciences

Islamabad, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 31592280BACKGROUND

  • 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.

    PMID: 23138046BACKGROUND

MeSH Terms

Conditions

Dental CariesDentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Nehal Amir, BDS

    Pakistan Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

January 5, 2023

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)