Post-operative Sensitivity in Composite Restorations

Not Applicable

Completed

• Conditions: Sensitivity, Tooth; Class II Dental Caries
• Interventions: Procedure: Group A ( Oblique Incremental Placement Technique); Procedure: Group B (Bulk-fill Placement technique)

• Registration Number: NCT06092567
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-12-20
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Study First Submitted: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-14
• Last Update Submitted: 2023-10-14
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Oblique Incremental Placement Techniique)	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.
Group B (Bulk-fill Placement Technique)	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.

Primary Outcome Measures

Name	Time	Method
Post-operative sensitivity in composite resin restoration	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).

Trial Locations

Locations (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University; 🇵🇰 Islamabad, Pakistan