Comparison of Postoperative Sensitivity in Posterior Teeth Using Conventional and Bulkfill Composites

February 25, 2025 updated by: Zahra Zubair, 28 Military Dental Centre Lahore

The purpose of this study is to compare the onset and severity of pain and postoperative sensitivity in patients after using conventional nanohybrid and bulkfill composites

Null Hypothesis:

There is no significant difference in mean postoperative sensitivity exhibited with conventional nano-hybrid versus bulkfill composites in mandibular molars with class 1 cavity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include 79 patients with class 1 carious mandibular molars. Teeth are divided into two groups based on composite placement techniques. In group 1, 39 patients are restored with conventional nanohybrid composites using an incremental layering technique. In group 2, 40 patients are restored with bulk-fill composites containing a single increment. After taking a brief history, informed consent will be taken from patients. The depth of the cavity will be determined using a periodontal probe not extending more than 3 mm. Preoperatively, pulp vitality will be assessed using the cold thermal test. A preoperative radiograph will also be taken. A rubber dam will be used. The cavity will be prepared and a selective etch technique will be used. Patients will be recalled after 24 hours and 1 week, thermal cold tests will be performed and a questionnaire containing the Numerical Rating Scale will be given to each patient for evaluation of post-operative pain felt after 24 hours and 1 week.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 042
        • Zahra Zubir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 1. Patients with ages range from 18- 55 years. 2. Male/ Female. 3. Mandibular molars with class 1 shallow-sized cavity with no history of pre-operative pain or sensitivity.

4. Ability to understand the use of pain and sensitivity scale. 5. Patients with adequate oral hygiene and willingness to participate in this study.

Exclusion Criteria:

- 1. Patients with deep caries of tooth associated with pain and sensitivity. 2. Patients who have consumed any type of medication before treatment. 3. Periapical pathologies (periapical abscess, sinus tract, periapical cyst, pulpal abscess.

4. Unfavorable location of the tooth, severe tooth malposition, and trismus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Nano-hybrid composites
Coltene Brilliant NG Conventional Nanohybrid composites
Device: conventional nanohybrid composites
Incremental layering technique is used for restoration
Other Names:
  • Coltene Brilliant NG conventional Nanohybrid
Experimental: Bulk fill composites
Coltene Fillup! Bulk fill COMPOSITES
Device: Bulk fill composites
Single increment in bulk form is applied for restoration
Other Names:
  • Coltene Fill up! BULKFILL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoidance of Postoperative sensitivity in posterior class 1 carious mandibular molars restored with composites
Time Frame: 24 hours and 1 week after restoring Class 1 caries
Numerical Rating Scale
24 hours and 1 week after restoring Class 1 caries

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

28 Military Dental Centre Lahore

Investigators

  • Principal Investigator: Zahra Zubair, BDS, 28 Military Dental Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPOSITES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Name, Gender, Age, and Tooth no., Diagnosed class 1 caries

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

zahra_zubair@hotmail.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Class I Dental Caries

Clinical Trials on conventional nanohybrid composites

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe