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

NCT06852586 | Completed FDA Device

• 1 other identifier: COMPOSITES
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class I Dental Caries

Keywords

Conventional nanohybrid composites, Bulk fill composites

Outcome Measures

Primary Outcomes (1)

• Avoidance of Postoperative sensitivity in posterior class 1 carious mandibular molars restored with composites

  Numerical Rating Scale

  24 hours and 1 week after restoring Class 1 caries

Study Arms (2)

Conventional Nano-hybrid composites

EXPERIMENTAL

Coltene Brilliant NG Conventional Nanohybrid composites

Device: conventional nanohybrid composites

Bulk fill composites

EXPERIMENTAL

Coltene Fillup! Bulk fill COMPOSITES

Device: Bulk fill composites

Interventions

conventional nanohybrid composites DEVICE

Incremental layering technique is used for restoration

Also known as: Coltene Brilliant NG conventional Nanohybrid

Conventional Nano-hybrid composites

Bulk fill composites DEVICE

Single increment in bulk form is applied for restoration

Also known as: Coltene Fill up! BULKFILL

Bulk fill composites

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.
• \. Unfavorable location of the tooth, severe tooth malposition, and trismus.

Sponsors & Collaborators

• 28 Military Dental Centre Lahore: lead

Study Sites (1)

Zahra Zubir

Lahore, Punjab Province, 042, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 31592052 BACKGROUND

• Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15.

  PMID: 34129074 BACKGROUND

• 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.

  PMID: 31531552 BACKGROUND

• Chiodera G, Orsini G, Tosco V, Monterubbianesi R, Manauta J, Devoto W, Putignano A. Essential Lines: a simplified filling and modeling technique for direct posterior composite restorations. Int J Esthet Dent. 2021 May 10;16(2):168-184.

  PMID: 33969973 BACKGROUND

• Veloso SRM, Lemos CAA, de Moraes SLD, do Egito Vasconcelos BC, Pellizzer EP, de Melo Monteiro GQ. Clinical performance of bulk-fill and conventional resin composite restorations in posterior teeth: a systematic review and meta-analysis. Clin Oral Investig. 2019 Jan;23(1):221-233. doi: 10.1007/s00784-018-2429-7. Epub 2018 Mar 28.

  PMID: 29594349 BACKGROUND

• Nascimento AS, Rodrigues JFB, Torres RHN, Santos KO, Fook MVL, Albuquerque MS, Lima EA, Filgueira PTD, Santos JBMD, Oliveira LJR, Braz R. Physicomechanical and thermal analysis of bulk-fill and conventional composites. Braz Oral Res. 2019 Mar 18;33:e008. doi: 10.1590/1807-3107bor-2019.vol33.0008.

  PMID: 30892408 BACKGROUND

• Yazici AR, Kutuk ZB, Ergin E, Karahan S, Antonson SA. Six-year clinical evaluation of bulk-fill and nanofill resin composite restorations. Clin Oral Investig. 2022 Jan;26(1):417-426. doi: 10.1007/s00784-021-04015-2. Epub 2021 Jun 10.

  PMID: 34110494 BACKGROUND

• Burke FJT, Mackenzie L. Bonding to dentine: an update on universal adhesives. Dent Update. 2021;48(8):620-31. doi: 10.12968/denu.2021.48.8.620.

  BACKGROUND

• Burke FJT, Mackenzie L, Sands P, Shortall ACC. Ten tips for avoiding post-operative sensitivity with posterior composite restorations. Dent Update. 2021;48(10):823-32. DOI: 10.12968/denu.2021.48.10.823.

  BACKGROUND

Study Officials

• Zahra Zubair, BDS

  28 Military Dental Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Zahra Zubair

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: August 26, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: February 28, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication
• Access Criteria: zahra\ zubair@hotmail.com

Locations

PA (1)