Post-operative Sensitivity in Composite Restorations

NCT ID: NCT06092567

Last Updated: 2023-10-23

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-07-24

Brief Summary

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

Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.

Detailed Description

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

After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.

Conditions

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

Class II Dental Caries Sensitivity, Tooth

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

In this study, participants allocated in two groups by Consecutive non-random sampling technique
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
This is a double-blinded study in which the participant and the outcome assessor masked.

Study Groups

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

Group A (Oblique Incremental Placement Techniique)

In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.

Group Type EXPERIMENTAL

Group A ( Oblique Incremental Placement Technique)

Intervention Type PROCEDURE

In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.

Group B (Bulk-fill Placement Technique)

In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm.

Group Type EXPERIMENTAL

Group B (Bulk-fill Placement technique)

Intervention Type PROCEDURE

In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm

Interventions

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

Group A ( Oblique Incremental Placement Technique)

In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.

Intervention Type PROCEDURE

Group B (Bulk-fill Placement technique)

In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Minimum 18 years of age with good general health
* Vital and Periodontally stable teeth
* Class-II primary carious lesions with a cavity depth of 3 to 5 mm
* Established contact with adjacent and opposing natural or prosthetic teeth
* Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)

Exclusion Criteria

* Teeth with a history of spontaneous pain
* Compromised oral health status
* Patients with parafunctional habits or temporomandibular disorders
* Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis
* Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 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

Pakistan Institute of Medical Sciences

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.

Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.

Reference Type BACKGROUND
PMID: 31592052 (View on PubMed)

Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.

Reference Type BACKGROUND
PMID: 31531552 (View on PubMed)

Other Identifiers

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

SOD/ERB/2022/04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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