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OpenTrials
Completed

NCT Number: NCT06092567

Post-operative Sensitivity in Composite Restorations

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A ( Oblique Incremental Placement Technique)

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)

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

Primary outcomes

  1. Post-operative sensitivity in composite resin restoration

    Time frame: Two weeks

    Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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