Post-operative Sensitivity in Composite Restorations

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative sensitivity in composite resin restoration	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).	Two weeks

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences
• Investigators: Principal Investigator: Nehal Amir, BDS, Pakistan Institute of Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Hypersensitivity; Dental Caries; Dentin Sensitivity
• Other Study ID Numbers: SOD/ERB/2022/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No