Post-operative Sensitivity in Resin Composites

NCT ID: NCT06242184

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-11-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caries,Dental Sensitivity, Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (Nano-fortified Adhesive)

Titanium dioxide nanoparticles incorporated in dentin adhesive

Group Type EXPERIMENTAL

Group A(Nano-fortified Adhesive)

Intervention Type PROCEDURE

Nano-fortified dentin adhesive

Group B (Adhesive without Nanoparticles)

Adhesive without nanoparticles

Group Type EXPERIMENTAL

Group B(Adhesive without nanoparticles)

Intervention Type PROCEDURE

Conventional adhesives without nanoparticles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group A(Nano-fortified Adhesive)

Nano-fortified dentin adhesive

Intervention Type PROCEDURE

Group B(Adhesive without nanoparticles)

Conventional adhesives without nanoparticles

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* participants with goof general health status
* Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
* Vital and Periodontally sound teeth

Exclusion Criteria

* Patient with Temporomandibular dysfunction
* History of spontaneous pain
* Endodontically treated teeth
* Patient on analgesics within the past two weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NEHAL AMIR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nehal Amir, BDS

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31592280 (View on PubMed)

Amir N, Mansoor A, Eeman N, Ahmed MN, Mansoor E, Hussain K, Palma PJ. Postoperative sensitivity of composites using novel Bacillus subtilis nanofortified adhesives: a triple-blind study. BMC Oral Health. 2024 Sep 12;24(1):1077. doi: 10.1186/s12903-024-04825-2.

Reference Type DERIVED
PMID: 39267015 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NAMIR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.